Trial Outcomes & Findings for Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older (NCT NCT04762680)
NCT ID: NCT04762680
Last Updated: 2025-09-18
Results Overview
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
3159 participants
Primary outcome timeframe
Up to 30 minutes after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)
Results posted on
2025-09-18
Participant Flow
The Phase 2 of study was conducted at 20 centers between 24 February 2021 and 01 May 2021. The Phase 3 of study was conducted at 110 centers between 29 July 2021 and 06 January 2023. CoV2 preS dTM= Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prefusion Spike delta TM, PBP=Pfizer/BioNTech Primed, MP= Moderna Primed, OUAP= Oxford University/AstraZeneca Primed, JJJP= J\&J/Janssen Primed and PP= Protein Primed.
722 participants were enrolled in Phase 2 and 2647 participants (supplemental Phase 3=2617 and exploratory Phase 3=30) were enrolled in Phase 3 of the study. A total of 3159 unique participants were enrolled in the study. Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. To be eligible, participants in the Booster Cohorts were required to have received a primary series, as administered in the Original Cohort.
Participant milestones
| Measure |
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant intermuscular (IM) injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant IM injection between 4 to 10 months after priming vaccine.
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Phase 2
STARTED
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0
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Phase 2
COMPLETED
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204
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Phase 2
NOT COMPLETED
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42
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35
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38
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Phase 3
STARTED
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0
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0
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0
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329
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378
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378
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113
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112
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108
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127
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101
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101
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105
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38
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38
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132
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78
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479
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0
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0
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0
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Phase 3
COMPLETED
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0
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0
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302
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338
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337
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102
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105
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100
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119
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95
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98
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94
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32
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31
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126
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71
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368
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0
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0
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0
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0
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Phase 3
NOT COMPLETED
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0
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0
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0
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27
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40
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41
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11
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7
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8
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8
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6
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3
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11
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6
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7
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6
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7
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111
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0
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0
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0
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0
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Phase 3 - Exploratory
STARTED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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4
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8
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9
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9
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Phase 3 - Exploratory
COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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4
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7
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9
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8
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Phase 3 - Exploratory
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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1
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Reasons for withdrawal
| Measure |
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant intermuscular (IM) injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Phase 2
Adverse Event
|
0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Phase 2
Protocol Violation
|
5
|
5
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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|
Phase 2
Withdrawal by Subject
|
23
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21
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28
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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|
Phase 2
Lost to Follow-up
|
14
|
8
|
9
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Phase 3
Adverse Event
|
0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
3
|
0
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0
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0
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0
|
|
Phase 3
Protocol Violation
|
0
|
0
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0
|
4
|
1
|
5
|
1
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0
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0
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0
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0
|
2
|
3
|
0
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0
|
1
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0
|
10
|
0
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0
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0
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0
|
|
Phase 3
Withdrawal by Subject
|
0
|
0
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0
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13
|
17
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12
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8
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3
|
2
|
4
|
3
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1
|
3
|
2
|
1
|
4
|
6
|
32
|
0
|
0
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0
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0
|
|
Phase 3
Lost to Follow-up
|
0
|
0
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0
|
9
|
22
|
24
|
2
|
4
|
6
|
4
|
3
|
0
|
5
|
4
|
6
|
1
|
1
|
66
|
0
|
0
|
0
|
0
|
|
Phase 3 - Exploratory
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase 3 - Exploratory
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
1
|
0
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0
|
Baseline Characteristics
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
Baseline characteristics by cohort
| Measure |
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=241 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=239 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=242 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=329 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=378 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=378 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=113 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=112 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=108 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=127 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=101 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=101 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=105 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
n=132 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
n=78 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
n=479 Participants
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)
n=4 Participants
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)
n=8 Participants
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)
n=9 Participants
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
n=9 Participants
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Total
n=3369 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
Phase 2 · <=18 years
|
0 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=722 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Age, Categorical
Phase 2 · Between 18 and 65 years
|
195 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
196 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
196 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
587 Participants
n=722 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Age, Categorical
Phase 2 · >=65 years
|
46 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
42 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
46 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
134 Participants
n=722 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Age, Categorical
Phase 3 · <=18 years
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
4 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
9 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
17 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Age, Categorical
Phase 3 · Between 18 and 65 years
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
266 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
357 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
353 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
88 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
97 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
94 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
95 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
86 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
87 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
98 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
35 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
36 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
92 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
40 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
467 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2291 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Age, Categorical
Phase 3 · >=65 years
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
63 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
17 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
23 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
25 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
15 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
13 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
32 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
15 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
14 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
40 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
38 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
309 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Age, Categorical
Phase 3 - Exploratory · <=18 years
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Age, Categorical
Phase 3 - Exploratory · Between 18 and 65 years
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
4 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
7 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
9 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
8 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
28 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Age, Categorical
Phase 3 - Exploratory · >=65 years
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Sex: Female, Male
Phase 2 · Female
|
123 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
114 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
122 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
359 Participants
n=722 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Sex: Female, Male
Phase 2 · Male
|
118 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
125 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
120 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
363 Participants
n=722 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Sex: Female, Male
Phase 3 · Female
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
181 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
208 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
199 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
68 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
60 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
64 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
59 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
42 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
48 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
63 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
19 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
20 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
64 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
38 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
215 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1348 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Sex: Female, Male
Phase 3 · Male
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
148 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
170 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
179 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
45 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
52 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
44 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
68 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
59 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
53 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
42 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
19 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
18 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
68 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
40 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
264 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1269 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Sex: Female, Male
Phase 3 - Exploratory · Female
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
8 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
20 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Sex: Female, Male
Phase 3 - Exploratory · Male
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
5 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
10 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 2 · American Indian or Alaska Native
|
22 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
24 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
20 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
5 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
5 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
4 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
20 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
14 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
15 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
148 Participants
n=3369 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 2 · Asian
|
13 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
10 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
10 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
19 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
12 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
13 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
7 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
11 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
4 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
7 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
18 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
136 Participants
n=3369 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 2 · Black or African American
|
14 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
23 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
20 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
15 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
54 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
61 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
16 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
32 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
5 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
16 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
10 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
7 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
52 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
337 Participants
n=3369 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 2 · Multiple
|
5 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
4 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
8 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
39 Participants
n=3369 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 2 · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
10 Participants
n=3369 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 2 · White
|
156 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
149 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
156 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
252 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
247 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
240 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
100 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
79 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
61 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
104 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
92 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
87 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
99 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
15 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
21 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
80 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
37 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
372 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2347 Participants
n=3369 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 2 · Missing
|
29 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
30 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
30 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
89 Participants
n=3369 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 2 · Not Reported
|
0 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
33 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
44 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
49 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
10 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
4 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
7 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
8 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
9 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
179 Participants
n=3369 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 2 · Unknown
|
0 Participants
n=241 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=239 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=242 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
4 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
8 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
23 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
22 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
10 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
84 Participants
n=3369 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 · American Indian or Alaska Native
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
5 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
5 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
4 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
20 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
14 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
15 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
82 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 · Asian
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
19 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
12 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
13 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
7 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
11 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
4 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
7 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
18 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
103 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 · Black or African American
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
15 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
54 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
61 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
16 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
32 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
5 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
16 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
10 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
7 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
52 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
280 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 · Multiple
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
8 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
28 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 · Native Hawaiian or Other Pacific Islander
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
5 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 · White
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
252 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
247 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
240 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
100 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
79 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
61 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
104 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
92 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
87 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
99 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
15 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
21 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
80 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
37 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
372 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1886 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 · Missing
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 · Not Reported
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
33 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
44 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
49 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
10 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
151 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 · Unknown
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
4 Participants
n=329 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
8 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=378 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=113 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
6 Participants
n=112 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
3 Participants
n=108 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=127 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=101 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=105 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=38 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
23 Participants
n=132 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
22 Participants
n=78 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
10 Participants
n=479 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
82 Participants
n=2617 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 - Exploratory · American Indian or Alaska Native
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 - Exploratory · Asian
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 - Exploratory · Black or African American
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 - Exploratory · Multiple
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 - Exploratory · Native Hawaiian or Other Pacific Islander
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 - Exploratory · White
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 - Exploratory · Missing
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 - Exploratory · Not Reported
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
4 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
7 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
8 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
9 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
28 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
|
Race/Ethnicity, Customized
Phase 3 - Exploratory · Unknown
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=4 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=8 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
1 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
0 Participants
n=9 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
2 Participants
n=30 Participants • Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
|
PRIMARY outcome
Timeframe: Up to 30 minutes after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)Population: Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=103 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=127 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=113 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=108 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
n=132 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
n=78 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
n=473 Participants
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=241 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=328 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=378 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=375 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=111 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)Population: The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants. Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF, and were considered to be related to the study vaccine administered. An injection site reaction was an AR at and around the injection site of the study vaccine. Systemic AR were all ARs that were not injection site reactions.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=102 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=127 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=113 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=108 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
n=132 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
n=78 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
n=460 Participants
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=238 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=237 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=239 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=326 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=367 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=370 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=110 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Injection site reaction
|
87 Participants
|
87 Participants
|
81 Participants
|
104 Participants
|
90 Participants
|
74 Participants
|
19 Participants
|
19 Participants
|
98 Participants
|
46 Participants
|
375 Participants
|
201 Participants
|
196 Participants
|
200 Participants
|
262 Participants
|
300 Participants
|
303 Participants
|
82 Participants
|
|
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Systemic reaction
|
61 Participants
|
75 Participants
|
62 Participants
|
75 Participants
|
67 Participants
|
65 Participants
|
14 Participants
|
17 Participants
|
88 Participants
|
36 Participants
|
359 Participants
|
191 Participants
|
191 Participants
|
185 Participants
|
198 Participants
|
238 Participants
|
242 Participants
|
67 Participants
|
PRIMARY outcome
Timeframe: Up to 21 days after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)Population: Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=103 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=127 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=113 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=108 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
n=132 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
n=78 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
n=473 Participants
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=241 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=328 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=378 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=375 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=111 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events
|
27 Participants
|
35 Participants
|
16 Participants
|
34 Participants
|
29 Participants
|
22 Participants
|
7 Participants
|
7 Participants
|
25 Participants
|
11 Participants
|
199 Participants
|
88 Participants
|
81 Participants
|
91 Participants
|
76 Participants
|
106 Participants
|
96 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.Population: Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=103 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=127 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=113 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=108 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
n=132 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
n=78 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
n=473 Participants
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=241 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=328 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=378 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=375 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=111 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
SAE
|
4 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
14 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
8 Participants
|
9 Participants
|
11 Participants
|
1 Participants
|
|
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
AESI
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
MAAE
|
24 Participants
|
29 Participants
|
19 Participants
|
31 Participants
|
28 Participants
|
19 Participants
|
7 Participants
|
7 Participants
|
42 Participants
|
32 Participants
|
110 Participants
|
42 Participants
|
48 Participants
|
59 Participants
|
80 Participants
|
106 Participants
|
117 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: Pre-vaccination on Day 1Population: The per-protocol analysis set (PPAS) Naïve-D01+D22 is a subset of the full analysis set (FAS).
Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=167 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=170 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=171 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20.0 titers
Since all participants have 20 titers at Day 1, leading to a zero standard error, this makes it impossible to calculate a meaningful confidence interval.
|
20.0 titers
Since all participants have 20 titers at Day 1, leading to a zero standard error, this makes it impossible to calculate a meaningful confidence interval.
|
20.0 titers
Since all participants have 20 titers at Day 1, leading to a zero standard error, this makes it impossible to calculate a meaningful confidence interval.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 36Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at Day 36 are reported.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=162 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=163 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=167 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2132 titers
Interval 1690.0 to 2688.0
|
2376 titers
Interval 1873.0 to 3015.0
|
2903 titers
Interval 2289.0 to 3683.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 36Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) were analyzed.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=159 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=158 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=161 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36
>=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
155 Participants
|
156 Participants
|
158 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36
>=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
154 Participants
|
154 Participants
|
157 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 36Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at Day 36 are reported.
Responders were participants who had baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=159 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=158 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=161 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
155 Participants
|
156 Participants
|
158 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-vaccination on Day 1Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter are reported.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=36 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=36 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=108 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=89 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=120 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=97 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=68 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=301 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=348 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=345 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=107 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=107 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=101 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=90 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Cohorts 1 and 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 1
B.1.351
|
345 titers
Interval 167.0 to 714.0
|
122 titers
Interval 55.3 to 268.0
|
97.7 titers
Interval 68.0 to 140.0
|
42.6 titers
Interval 32.5 to 55.7
|
54.1 titers
Interval 41.4 to 70.7
|
36.8 titers
Interval 28.8 to 47.1
|
70.3 titers
Interval 47.9 to 103.0
|
—
|
—
|
—
|
—
|
70.1 titers
Interval 60.3 to 81.4
|
176 titers
Interval 142.0 to 217.0
|
149 titers
Interval 120.0 to 184.0
|
122 titers
Interval 95.4 to 157.0
|
258 titers
Interval 182.0 to 364.0
|
296 titers
Interval 207.0 to 424.0
|
43.3 titers
Interval 32.0 to 58.5
|
|
Phase 3: Cohorts 1 and 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 1
D614G
|
1188 titers
Interval 567.0 to 2490.0
|
447 titers
Interval 217.0 to 921.0
|
274 titers
Interval 182.0 to 413.0
|
222 titers
Interval 155.0 to 318.0
|
265 titers
Interval 190.0 to 369.0
|
134 titers
Interval 95.7 to 186.0
|
159 titers
Interval 97.4 to 260.0
|
—
|
—
|
—
|
—
|
320 titers
Interval 275.0 to 373.0
|
678 titers
Interval 558.0 to 824.0
|
579 titers
Interval 478.0 to 701.0
|
668 titers
Interval 537.0 to 830.0
|
1107 titers
Interval 816.0 to 1503.0
|
1347 titers
Interval 977.0 to 1858.0
|
137 titers
Interval 98.0 to 193.0
|
PRIMARY outcome
Timeframe: Cohorts 1 and 2: 14 days post-vaccination on Day 1, Day 15; Comparator: 14 days post-vaccination on Day 22, Day 36Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter are reported.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=31 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=34 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=119 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=91 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=118 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=93 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=72 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=307 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=301 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=325 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=334 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=101 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=93 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=96 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=94 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Cohorts 1, 2 and Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination
B.1.351
|
6872 titers
Interval 4482.0 to 10537.0
|
5057 titers
Interval 3416.0 to 7488.0
|
7452 titers
Interval 6212.0 to 8939.0
|
2054 titers
Interval 1642.0 to 2568.0
|
2062 titers
Interval 1708.0 to 2489.0
|
3099 titers
Interval 2386.0 to 4026.0
|
13300 titers
Interval 9817.0 to 18018.0
|
413 titers
Interval 346.0 to 493.0
|
—
|
—
|
—
|
2610 titers
Interval 2316.0 to 2942.0
|
7021 titers
Interval 6262.0 to 7873.0
|
4900 titers
Interval 4370.0 to 5494.0
|
2222 titers
Interval 1754.0 to 2814.0
|
9449 titers
Interval 7376.0 to 12104.0
|
6581 titers
Interval 5340.0 to 8111.0
|
4610 titers
Interval 3689.0 to 5760.0
|
|
Phase 3: Cohorts 1, 2 and Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination
D614G
|
11005 titers
Interval 7533.0 to 16078.0
|
11624 titers
Interval 8086.0 to 16710.0
|
22457 titers
Interval 19123.0 to 26374.0
|
6875 titers
Interval 5587.0 to 8460.0
|
6257 titers
Interval 5313.0 to 7369.0
|
5855 titers
Interval 4669.0 to 7344.0
|
25002 titers
Interval 18441.0 to 33897.0
|
3611 titers
Interval 3086.0 to 4224.0
|
—
|
—
|
—
|
6964 titers
Interval 6268.0 to 7737.0
|
9995 titers
Interval 8976.0 to 11129.0
|
8430 titers
Interval 7572.0 to 9386.0
|
6347 titers
Interval 5207.0 to 7736.0
|
14240 titers
Interval 11257.0 to 18013.0
|
12522 titers
Interval 10368.0 to 15123.0
|
5536 titers
Interval 4436.0 to 6910.0
|
PRIMARY outcome
Timeframe: Day 36Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter are reported.
Responders were participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=301 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Comparator: Percentage of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 36
D614G
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
99.3 percentage of participants
Interval 97.6 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Percentage of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 36
B.1.351
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
91.0 percentage of participants
Interval 87.1 to 94.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-vaccination on Days 22, 78, 134, 202, 292, and 387Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=159 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=160 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=160 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 134
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
225 titers
Interval 160.0 to 318.0
|
249 titers
Interval 182.0 to 340.0
|
260 titers
Interval 190.0 to 358.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 202
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
254 titers
Interval 158.0 to 408.0
|
344 titers
Interval 208.0 to 570.0
|
259 titers
Interval 159.0 to 421.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
36.0 titers
Interval 29.4 to 44.2
|
39.6 titers
Interval 32.3 to 48.6
|
47.3 titers
Interval 37.8 to 59.1
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
467 titers
Interval 361.0 to 606.0
|
558 titers
Interval 438.0 to 711.0
|
569 titers
Interval 458.0 to 707.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 292
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12145 titers
Interval 3643.0 to 40491.0
|
2518 titers
Interval 335.0 to 18928.0
|
804 titers
Interval 108.0 to 6014.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 387
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17837 titers
Interval 9491.0 to 33522.0
|
46305 titers
Interval 24179.0 to 88677.0
|
8353 titers
Interval 1414.0 to 49336.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and Post-vaccination on Days 22, 78, 134, 202, 292, and 387Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) were analyzed.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=159 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=160 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=159 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 78: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
105 Participants
|
115 Participants
|
110 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 387: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 22: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
35 Participants
|
44 Participants
|
53 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 22: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
28 Participants
|
36 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 78: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
108 Participants
|
116 Participants
|
113 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 134: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
85 Participants
|
87 Participants
|
82 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 134: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
75 Participants
|
83 Participants
|
76 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 202: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
57 Participants
|
62 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 202: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
53 Participants
|
57 Participants
|
60 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 292: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
|
10 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 292: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
|
9 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 387: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-vaccination on Days 22, 78, 134, 202, 292, and 387Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Responders were participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay).
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=159 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=160 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=159 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
35 Participants
|
44 Participants
|
53 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
108 Participants
|
116 Participants
|
113 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 134
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
85 Participants
|
87 Participants
|
82 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 202
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
57 Participants
|
62 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 292
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
|
10 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
Day 387
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-enzyme-linked immunosorbent assay (ELISA) and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=169 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=172 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=176 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387
Day 134
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2750 titers
Interval 2104.0 to 3594.0
|
2977 titers
Interval 2305.0 to 3846.0
|
2696 titers
Interval 2064.0 to 3521.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387
Day 202
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1414 titers
Interval 983.0 to 2033.0
|
1961 titers
Interval 1369.0 to 2809.0
|
1438 titers
Interval 978.0 to 2113.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387
Day 292
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
40589 titers
Interval 10633.0 to 155000.0
|
9247 titers
Interval 1625.0 to 52615.0
|
5557 titers
Interval 1183.0 to 26116.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387
Day 387
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
61087 titers
Interval 40242.0 to 92728.0
|
58674 titers
Interval 12370.0 to 278000.0
|
16234 titers
Interval 3146.0 to 83760.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.3 titers
Interval 9.54 to 11.1
|
9.99 titers
Interval 9.52 to 10.5
|
10.2 titers
Interval 9.77 to 10.7
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387
Day 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
103 titers
Interval 80.6 to 131.0
|
149 titers
Interval 119.0 to 187.0
|
228 titers
Interval 182.0 to 285.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387
Day 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
15533 titers
Interval 13000.0 to 18560.0
|
17176 titers
Interval 14468.0 to 20390.0
|
18003 titers
Interval 15039.0 to 21550.0
|
—
|
—
|
—
|
—
|
|
Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387
Day 78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6572 titers
Interval 5469.0 to 7897.0
|
7526 titers
Interval 6112.0 to 9267.0
|
7133 titers
Interval 5848.0 to 8700.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay. Participants with binding antibodies concentration \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) were analyzed.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=166 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=170 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=175 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 22: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
117 Participants
|
136 Participants
|
156 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 22: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
141 Participants
|
155 Participants
|
161 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 36: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
159 Participants
|
160 Participants
|
165 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 36: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
158 Participants
|
160 Participants
|
165 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 78: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
121 Participants
|
124 Participants
|
124 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 78: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
121 Participants
|
124 Participants
|
124 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 134: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
101 Participants
|
109 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 134: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
101 Participants
|
109 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 202: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
85 Participants
|
91 Participants
|
86 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 202: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
85 Participants
|
91 Participants
|
85 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 292: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11 Participants
|
12 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 292: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11 Participants
|
12 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 387: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
|
10 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 387: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
|
10 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Responders were participants who had baseline values below LLOQ with detectable antibody concentration above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=166 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=170 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=175 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
159 Participants
|
160 Participants
|
165 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
139 Participants
|
154 Participants
|
161 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
121 Participants
|
124 Participants
|
124 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 134
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
101 Participants
|
109 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 202
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
85 Participants
|
91 Participants
|
86 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 292
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11 Participants
|
12 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387
Day 387
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10 Participants
|
10 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-vaccination on Days 29, 91, 181, and 366Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=311 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=106 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=117 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=96 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366
Day 91: B.1.351
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1522 titers
Interval 1304.0 to 1776.0
|
1254 titers
Interval 920.0 to 1711.0
|
949 titers
Interval 702.0 to 1281.0
|
711 titers
Interval 540.0 to 936.0
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366
Day 29: D614G
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5795 titers
Interval 5222.0 to 6432.0
|
5743 titers
Interval 4668.0 to 7065.0
|
4869 titers
Interval 4113.0 to 5764.0
|
4400 titers
Interval 3566.0 to 5430.0
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366
Day 29: B.1.351
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2078 titers
Interval 1844.0 to 2342.0
|
1726 titers
Interval 1355.0 to 2198.0
|
1790 titers
Interval 1452.0 to 2207.0
|
1390 titers
Interval 1095.0 to 1764.0
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366
Day 91: D614G
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4623 titers
Interval 4037.0 to 5295.0
|
4879 titers
Interval 3774.0 to 6308.0
|
2704 titers
Interval 2065.0 to 3541.0
|
2509 titers
Interval 1954.0 to 3223.0
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366
Day 181: D614G
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7502 titers
Interval 6161.0 to 9135.0
|
10068 titers
Interval 6940.0 to 14605.0
|
2658 titers
Interval 1834.0 to 3852.0
|
5649 titers
Interval 3695.0 to 8635.0
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366
Day 181: B.1.351
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2328 titers
Interval 1827.0 to 2966.0
|
3217 titers
Interval 2073.0 to 4992.0
|
1035 titers
Interval 650.0 to 1648.0
|
1853 titers
Interval 1095.0 to 3134.0
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366
Day 366: D614G
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10224 titers
Interval 8101.0 to 12903.0
|
10567 titers
Interval 6608.0 to 16898.0
|
2940 titers
Interval 1779.0 to 4858.0
|
6314 titers
Interval 3847.0 to 10361.0
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366
Day 366: B.1.351
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3419 titers
Interval 2572.0 to 4545.0
|
3349 titers
Interval 1929.0 to 5812.0
|
942 titers
Interval 533.0 to 1664.0
|
2233 titers
Interval 1267.0 to 3937.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) were analyzed.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=290 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=104 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=114 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=87 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
D614G; Day 29: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
266 Participants
|
91 Participants
|
97 Participants
|
73 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
D614G; Day 15: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
263 Participants
|
86 Participants
|
95 Participants
|
70 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
D614G; Day 15: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
252 Participants
|
70 Participants
|
87 Participants
|
66 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
D614G; Day 29: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
250 Participants
|
79 Participants
|
87 Participants
|
68 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
D614G; Day 91: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
208 Participants
|
74 Participants
|
67 Participants
|
62 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
D614G; Day 91: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
187 Participants
|
57 Participants
|
58 Participants
|
56 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
D614G; Day 181: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
167 Participants
|
50 Participants
|
54 Participants
|
51 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
D614G; Day 181: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
149 Participants
|
44 Participants
|
42 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
D614G; Day 366: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
141 Participants
|
38 Participants
|
33 Participants
|
31 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
D614G; Day 366: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
129 Participants
|
34 Participants
|
28 Participants
|
31 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
B.1.351; Day 15: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
258 Participants
|
76 Participants
|
109 Participants
|
78 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
B.1.351; Day 15: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
246 Participants
|
67 Participants
|
103 Participants
|
76 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
B.1.351; Day 29: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
261 Participants
|
79 Participants
|
109 Participants
|
83 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
B.1.351; Day 29: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
245 Participants
|
70 Participants
|
103 Participants
|
80 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
B.1.351; Day 91: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
203 Participants
|
64 Participants
|
75 Participants
|
68 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
B.1.351; Day 91: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
189 Participants
|
54 Participants
|
67 Participants
|
66 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
B.1.351; Day 181: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
162 Participants
|
38 Participants
|
59 Participants
|
54 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
B.1.351; Day 181: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
145 Participants
|
38 Participants
|
51 Participants
|
46 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
B.1.351; Day 366: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
137 Participants
|
32 Participants
|
36 Participants
|
34 Participants
|
—
|
—
|
—
|
|
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
B.1.351; Day 366: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
127 Participants
|
30 Participants
|
34 Participants
|
30 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1 and 2: 14 days post-vaccination on Day 1 (Day 15); Comparator: 14 days post-vaccination on Day 22 (Day 36)Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
Seroresponse was defined as a \>=4-fold rise in serum neutralization titer against SARS-CoV-2 D614G strain and B.1.351 variant (post/pre) at Day 15 or Day 36 relative to Day 0 or Day 22. Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with serum neutralization assay (monogram assay). Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=31 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=33 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=99 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=81 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=114 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=91 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=64 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=301 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=278 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=315 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=320 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=98 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=92 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=91 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=87 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Cohorts 1, 2 and Comparator: Percentage of Participants With Seroresponse Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination
B.1.351
|
75.9 percentage of participants
Interval 56.5 to 89.7
|
77.4 percentage of participants
Interval 58.9 to 90.4
|
85.9 percentage of participants
Interval 77.4 to 92.0
|
93.8 percentage of participants
Interval 86.2 to 98.0
|
90.4 percentage of participants
Interval 83.4 to 95.1
|
96.7 percentage of participants
Interval 90.7 to 99.3
|
90.6 percentage of participants
Interval 80.7 to 96.5
|
86.6 percentage of participants
Interval 82.1 to 90.3
|
—
|
—
|
—
|
92.5 percentage of participants
Interval 88.6 to 95.3
|
83.3 percentage of participants
Interval 78.6 to 87.3
|
82.9 percentage of participants
Interval 78.1 to 87.0
|
84.8 percentage of participants
Interval 75.0 to 91.9
|
83.3 percentage of participants
Interval 73.6 to 90.6
|
80.0 percentage of participants
Interval 69.9 to 87.9
|
95.4 percentage of participants
Interval 88.6 to 98.7
|
|
Phase 3: Cohorts 1, 2 and Comparator: Percentage of Participants With Seroresponse Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination
D614G
|
58.1 percentage of participants
Interval 39.1 to 75.5
|
78.8 percentage of participants
Interval 61.1 to 91.0
|
84.8 percentage of participants
Interval 76.2 to 91.3
|
88.0 percentage of participants
Interval 78.4 to 94.4
|
86.1 percentage of participants
Interval 77.8 to 92.2
|
89.8 percentage of participants
Interval 81.5 to 95.2
|
90.6 percentage of participants
Interval 80.7 to 96.5
|
99.0 percentage of participants
Interval 97.1 to 99.8
|
—
|
—
|
—
|
90.6 percentage of participants
Interval 86.6 to 93.8
|
73.7 percentage of participants
Interval 68.4 to 78.4
|
75.6 percentage of participants
Interval 70.5 to 80.2
|
71.4 percentage of participants
Interval 61.4 to 80.1
|
72.8 percentage of participants
Interval 62.6 to 81.6
|
63.7 percentage of participants
Interval 53.0 to 73.6
|
89.7 percentage of participants
Interval 81.3 to 95.2
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, 91, 181, and 366Population: The PPAS is a subset of the FAS. Only participants analyzed at specific timepoint are reported. Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort. No participants were analyzed and thus data was not collected at Day 366 for "Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)" reporting group.
Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=37 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=37 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=130 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=99 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=125 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=99 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=77 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=326 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=362 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=361 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=110 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=108 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=107 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=97 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366
Day 1
|
2290 titers
Interval 1068.0 to 4908.0
|
996 titers
Interval 491.0 to 2021.0
|
1357 titers
Interval 1004.0 to 1834.0
|
608 titers
Interval 457.0 to 809.0
|
993 titers
Interval 781.0 to 1262.0
|
537 titers
Interval 420.0 to 687.0
|
969 titers
Interval 688.0 to 1365.0
|
—
|
—
|
—
|
—
|
1888 titers
Interval 1687.0 to 2114.0
|
3032 titers
Interval 2621.0 to 3507.0
|
2580 titers
Interval 2228.0 to 2987.0
|
3236 titers
Interval 2729.0 to 3839.0
|
3285 titers
Interval 2534.0 to 4259.0
|
3505 titers
Interval 2747.0 to 4471.0
|
564 titers
Interval 427.0 to 747.0
|
|
Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366
Day 181
|
11275 titers
Interval 7727.0 to 16451.0
|
19231 titers
Interval 12448.0 to 29712.0
|
21387 titers
Interval 17825.0 to 25661.0
|
12342 titers
Interval 8420.0 to 18092.0
|
7281 titers
Interval 5366.0 to 9880.0
|
10649 titers
Interval 7312.0 to 15510.0
|
20803 titers
Interval 16151.0 to 26794.0
|
—
|
—
|
—
|
—
|
20073 titers
Interval 17076.0 to 23596.0
|
20450 titers
Interval 18029.0 to 23195.0
|
18628 titers
Interval 16117.0 to 21530.0
|
25701 titers
Interval 17854.0 to 36998.0
|
25615 titers
Interval 20346.0 to 32248.0
|
24500 titers
Interval 19714.0 to 30448.0
|
8665 titers
Interval 6100.0 to 12311.0
|
|
Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366
Day 15
|
31067 titers
Interval 24221.0 to 39849.0
|
34534 titers
Interval 26146.0 to 45614.0
|
65824 titers
Interval 57576.0 to 75254.0
|
21758 titers
Interval 18254.0 to 25935.0
|
21654 titers
Interval 18927.0 to 24775.0
|
28783 titers
Interval 24417.0 to 33930.0
|
77057 titers
Interval 61772.0 to 96125.0
|
—
|
—
|
—
|
—
|
26710 titers
Interval 24337.0 to 29314.0
|
36428 titers
Interval 33227.0 to 39938.0
|
30892 titers
Interval 27925.0 to 34174.0
|
27390 titers
Interval 23220.0 to 32309.0
|
43611 titers
Interval 35852.0 to 53049.0
|
34704 titers
Interval 29398.0 to 40968.0
|
23775 titers
Interval 19137.0 to 29537.0
|
|
Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366
Day 29
|
29315 titers
Interval 22236.0 to 38647.0
|
24388 titers
Interval 17369.0 to 34243.0
|
60707 titers
Interval 52764.0 to 69845.0
|
14014 titers
Interval 11798.0 to 16647.0
|
13305 titers
Interval 11657.0 to 15186.0
|
17729 titers
Interval 14944.0 to 21034.0
|
65974 titers
Interval 53800.0 to 80902.0
|
—
|
—
|
—
|
—
|
20212 titers
Interval 18487.0 to 22097.0
|
33416 titers
Interval 30407.0 to 36723.0
|
27083 titers
Interval 24480.0 to 29964.0
|
23079 titers
Interval 19417.0 to 27431.0
|
48428 titers
Interval 39336.0 to 59623.0
|
41018 titers
Interval 34290.0 to 49065.0
|
16401 titers
Interval 13253.0 to 20296.0
|
|
Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366
Day 91
|
18463 titers
Interval 13497.0 to 25255.0
|
16236 titers
Interval 9684.0 to 27219.0
|
41282 titers
Interval 34967.0 to 48736.0
|
9032 titers
Interval 7387.0 to 11043.0
|
9792 titers
Interval 8093.0 to 11849.0
|
13189 titers
Interval 10078.0 to 17261.0
|
40566 titers
Interval 32032.0 to 51373.0
|
—
|
—
|
—
|
—
|
18845 titers
Interval 16780.0 to 21165.0
|
29384 titers
Interval 25972.0 to 33244.0
|
23908 titers
Interval 20860.0 to 27402.0
|
20758 titers
Interval 16506.0 to 26107.0
|
37791 titers
Interval 29062.0 to 49140.0
|
35363 titers
Interval 28656.0 to 43639.0
|
10365 titers
Interval 8105.0 to 13255.0
|
|
Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366
Day 366
|
12176 titers
Interval 8897.0 to 16664.0
|
12002 titers
Interval 8266.0 to 17425.0
|
32168 titers
Interval 25602.0 to 40417.0
|
14545 titers
Interval 4542.0 to 46582.0
|
—
|
10937 titers
Interval 6565.0 to 18220.0
|
33194 titers
Interval 24774.0 to 44476.0
|
—
|
—
|
—
|
—
|
41232 titers
Interval 28233.0 to 60218.0
|
19545 titers
Interval 17037.0 to 22422.0
|
19989 titers
Interval 17351.0 to 23028.0
|
32368 titers
Interval 16026.0 to 65374.0
|
25800 titers
Interval 20031.0 to 33232.0
|
19848 titers
Interval 15543.0 to 25345.0
|
10382 titers
Interval 6531.0 to 16505.0
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported. Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort. No participants were analyzed and thus data was not collected at Day 366 for "Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)" reporting group.
Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay. Participants with binding antibodies concentration \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) were analyzed.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=34 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=34 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=124 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=96 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=119 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=93 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=72 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=312 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=332 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=340 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=106 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=98 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=101 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=94 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366
Day 15: >=2-fold rise
|
24 Participants
|
29 Participants
|
108 Participants
|
88 Participants
|
114 Participants
|
92 Participants
|
69 Participants
|
—
|
—
|
—
|
—
|
287 Participants
|
276 Participants
|
292 Participants
|
94 Participants
|
84 Participants
|
87 Participants
|
92 Participants
|
|
Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366
Day 15: >=4-fold rise
|
19 Participants
|
28 Participants
|
103 Participants
|
84 Participants
|
106 Participants
|
90 Participants
|
67 Participants
|
—
|
—
|
—
|
—
|
265 Participants
|
234 Participants
|
265 Participants
|
72 Participants
|
73 Participants
|
69 Participants
|
85 Participants
|
|
Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366
Day 29: >=4-fold rise
|
19 Participants
|
27 Participants
|
109 Participants
|
84 Participants
|
96 Participants
|
86 Participants
|
66 Participants
|
—
|
—
|
—
|
—
|
253 Participants
|
243 Participants
|
254 Participants
|
71 Participants
|
75 Participants
|
74 Participants
|
85 Participants
|
|
Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366
Day 181: >=4-fold rise
|
11 Participants
|
17 Participants
|
89 Participants
|
51 Participants
|
45 Participants
|
40 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
146 Participants
|
160 Participants
|
167 Participants
|
38 Participants
|
55 Participants
|
48 Participants
|
45 Participants
|
|
Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366
Day 366: >=4-fold rise
|
11 Participants
|
14 Participants
|
77 Participants
|
7 Participants
|
—
|
23 Participants
|
52 Participants
|
—
|
—
|
—
|
—
|
26 Participants
|
147 Participants
|
165 Participants
|
13 Participants
|
56 Participants
|
37 Participants
|
23 Participants
|
|
Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366
Day 91: >=2-fold rise
|
17 Participants
|
23 Participants
|
105 Participants
|
79 Participants
|
82 Participants
|
59 Participants
|
65 Participants
|
—
|
—
|
—
|
—
|
227 Participants
|
210 Participants
|
217 Participants
|
73 Participants
|
70 Participants
|
76 Participants
|
61 Participants
|
|
Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366
Day 181: >=2-fold rise
|
14 Participants
|
20 Participants
|
98 Participants
|
56 Participants
|
59 Participants
|
49 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
175 Participants
|
189 Participants
|
193 Participants
|
43 Participants
|
63 Participants
|
59 Participants
|
53 Participants
|
|
Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366
Day 91: >=4-fold rise
|
14 Participants
|
22 Participants
|
98 Participants
|
72 Participants
|
69 Participants
|
56 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
197 Participants
|
183 Participants
|
184 Participants
|
60 Participants
|
62 Participants
|
58 Participants
|
57 Participants
|
|
Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366
Day 366: >=2-fold rise
|
12 Participants
|
17 Participants
|
83 Participants
|
9 Participants
|
—
|
27 Participants
|
53 Participants
|
—
|
—
|
—
|
—
|
27 Participants
|
174 Participants
|
184 Participants
|
15 Participants
|
62 Participants
|
49 Participants
|
26 Participants
|
|
Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366
Day 29: >=2-fold rise
|
24 Participants
|
27 Participants
|
115 Participants
|
91 Participants
|
111 Participants
|
90 Participants
|
69 Participants
|
—
|
—
|
—
|
—
|
285 Participants
|
278 Participants
|
285 Participants
|
93 Participants
|
87 Participants
|
87 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, and 91Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported. Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=72 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=36 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=123 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=348 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=345 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=107 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=101 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=94 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=97 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=36 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, and 91
Day 29: D614G
|
—
|
—
|
—
|
16425 titers
Interval 12103.0 to 22291.0
|
9711 titers
Interval 6526.0 to 14450.0
|
16032 titers
Interval 13535.0 to 18989.0
|
—
|
—
|
—
|
—
|
—
|
14065 titers
Interval 12399.0 to 15954.0
|
10885 titers
Interval 9664.0 to 12261.0
|
16286 titers
Interval 12808.0 to 20710.0
|
16874 titers
Interval 13763.0 to 20688.0
|
6320 titers
Interval 4941.0 to 8083.0
|
6370 titers
Interval 5014.0 to 8093.0
|
9521 titers
Interval 6555.0 to 13828.0
|
|
Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, and 91
Day 91: D614G
|
—
|
—
|
—
|
13641 titers
Interval 9766.0 to 19055.0
|
5797 titers
Interval 3725.0 to 9024.0
|
14498 titers
Interval 11931.0 to 17618.0
|
—
|
—
|
—
|
—
|
—
|
11037 titers
Interval 9530.0 to 12782.0
|
8523 titers
Interval 7284.0 to 9973.0
|
13701 titers
Interval 10206.0 to 18392.0
|
12424 titers
Interval 9586.0 to 16103.0
|
3620 titers
Interval 2680.0 to 4891.0
|
3981 titers
Interval 2812.0 to 5637.0
|
5880 titers
Interval 3125.0 to 11064.0
|
|
Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, and 91
Day 91: B.1.351
|
—
|
—
|
—
|
8990 titers
Interval 6284.0 to 12861.0
|
3374 titers
Interval 2161.0 to 5269.0
|
6455 titers
Interval 5117.0 to 8143.0
|
—
|
—
|
—
|
—
|
—
|
6557 titers
Interval 5617.0 to 7654.0
|
4359 titers
Interval 3673.0 to 5172.0
|
8141 titers
Interval 5982.0 to 11080.0
|
5474 titers
Interval 4176.0 to 7175.0
|
2456 titers
Interval 1792.0 to 3364.0
|
2029 titers
Interval 1376.0 to 2993.0
|
2405 titers
Interval 1093.0 to 5295.0
|
|
Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, and 91
Day 1: D614G
|
—
|
—
|
—
|
159 titers
Interval 97.4 to 260.0
|
1188 titers
Interval 567.0 to 2490.0
|
274 titers
Interval 182.0 to 413.0
|
—
|
—
|
—
|
—
|
—
|
678 titers
Interval 558.0 to 824.0
|
579 titers
Interval 478.0 to 701.0
|
1107 titers
Interval 816.0 to 1503.0
|
1347 titers
Interval 977.0 to 1858.0
|
137 titers
Interval 98.0 to 193.0
|
134 titers
Interval 95.7 to 186.0
|
447 titers
Interval 217.0 to 921.0
|
|
Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, and 91
Day 1: B.1.351
|
—
|
—
|
—
|
70.3 titers
Interval 47.9 to 103.0
|
345 titers
Interval 167.0 to 714.0
|
97.7 titers
Interval 68.0 to 140.0
|
—
|
—
|
—
|
—
|
—
|
176 titers
Interval 142.0 to 217.0
|
149 titers
Interval 120.0 to 184.0
|
258 titers
Interval 182.0 to 364.0
|
296 titers
Interval 207.0 to 424.0
|
43.3 titers
Interval 32.0 to 58.5
|
36.8 titers
Interval 28.8 to 47.1
|
122 titers
Interval 55.3 to 268.0
|
|
Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, and 91
Day 15: D614G
|
—
|
—
|
—
|
25002 titers
Interval 18441.0 to 33897.0
|
11005 titers
Interval 7533.0 to 16078.0
|
22457 titers
Interval 19123.0 to 26374.0
|
—
|
—
|
—
|
—
|
—
|
9995 titers
Interval 8976.0 to 11129.0
|
8430 titers
Interval 7572.0 to 9386.0
|
14240 titers
Interval 11257.0 to 18013.0
|
12522 titers
Interval 10368.0 to 15123.0
|
5536 titers
Interval 4436.0 to 6910.0
|
5855 titers
Interval 4669.0 to 7344.0
|
11624 titers
Interval 8086.0 to 16710.0
|
|
Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, and 91
Day 15: B.1.351
|
—
|
—
|
—
|
13300 titers
Interval 9817.0 to 18018.0
|
6872 titers
Interval 4482.0 to 10537.0
|
7452 titers
Interval 6212.0 to 8939.0
|
—
|
—
|
—
|
—
|
—
|
7021 titers
Interval 6262.0 to 7873.0
|
4900 titers
Interval 4370.0 to 5494.0
|
9449 titers
Interval 7376.0 to 12104.0
|
6581 titers
Interval 5340.0 to 8111.0
|
4610 titers
Interval 3689.0 to 5760.0
|
3099 titers
Interval 2386.0 to 4026.0
|
5057 titers
Interval 3416.0 to 7488.0
|
|
Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, and 91
Day 29: B.1.351
|
—
|
—
|
—
|
12712 titers
Interval 9376.0 to 17234.0
|
6028 titers
Interval 3889.0 to 9342.0
|
7185 titers
Interval 5841.0 to 8838.0
|
—
|
—
|
—
|
—
|
—
|
8947 titers
Interval 7845.0 to 10203.0
|
6045 titers
Interval 5307.0 to 6886.0
|
10264 titers
Interval 7924.0 to 13296.0
|
8139 titers
Interval 6470.0 to 10239.0
|
4736 titers
Interval 3680.0 to 6096.0
|
3103 titers
Interval 2340.0 to 4115.0
|
4007 titers
Interval 2553.0 to 6290.0
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, and 91Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported. Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) were analyzed.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=64 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=33 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=103 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=318 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=324 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=99 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=95 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=87 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=91 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=33 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
D614G; Day 15: >=2-fold rise
|
—
|
—
|
—
|
60 Participants
|
26 Participants
|
86 Participants
|
—
|
—
|
—
|
—
|
—
|
267 Participants
|
269 Participants
|
79 Participants
|
77 Participants
|
85 Participants
|
84 Participants
|
30 Participants
|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
D614G; Day 29: >=4-fold rise
|
—
|
—
|
—
|
56 Participants
|
15 Participants
|
85 Participants
|
—
|
—
|
—
|
—
|
—
|
240 Participants
|
251 Participants
|
74 Participants
|
67 Participants
|
80 Participants
|
80 Participants
|
23 Participants
|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
D614G; Day 91: >=2-fold rise
|
—
|
—
|
—
|
57 Participants
|
16 Participants
|
81 Participants
|
—
|
—
|
—
|
—
|
—
|
199 Participants
|
208 Participants
|
69 Participants
|
70 Participants
|
57 Participants
|
51 Participants
|
20 Participants
|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
B.1.351; Day 15: >=4-fold rise
|
—
|
—
|
—
|
58 Participants
|
22 Participants
|
85 Participants
|
—
|
—
|
—
|
—
|
—
|
249 Participants
|
247 Participants
|
70 Participants
|
68 Participants
|
83 Participants
|
88 Participants
|
24 Participants
|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
B.1.351; Day 29: >=2-fold rise
|
—
|
—
|
—
|
62 Participants
|
28 Participants
|
95 Participants
|
—
|
—
|
—
|
—
|
—
|
278 Participants
|
277 Participants
|
81 Participants
|
79 Participants
|
86 Participants
|
87 Participants
|
26 Participants
|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
B.1.351; Day 29: >=4-fold rise
|
—
|
—
|
—
|
58 Participants
|
20 Participants
|
92 Participants
|
—
|
—
|
—
|
—
|
—
|
258 Participants
|
261 Participants
|
75 Participants
|
70 Participants
|
84 Participants
|
87 Participants
|
25 Participants
|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
B.1.351; Day 91: >=2-fold rise
|
—
|
—
|
—
|
58 Participants
|
22 Participants
|
87 Participants
|
—
|
—
|
—
|
—
|
—
|
212 Participants
|
207 Participants
|
69 Participants
|
68 Participants
|
56 Participants
|
56 Participants
|
21 Participants
|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
B.1.351; Day 91: >=4-fold rise
|
—
|
—
|
—
|
55 Participants
|
16 Participants
|
80 Participants
|
—
|
—
|
—
|
—
|
—
|
195 Participants
|
197 Participants
|
62 Participants
|
60 Participants
|
56 Participants
|
53 Participants
|
17 Participants
|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
D614G; Day 15: >=4-fold rise
|
—
|
—
|
—
|
58 Participants
|
18 Participants
|
84 Participants
|
—
|
—
|
—
|
—
|
—
|
232 Participants
|
242 Participants
|
67 Participants
|
58 Participants
|
78 Participants
|
79 Participants
|
26 Participants
|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
D614G; Day 29: >=2-fold rise
|
—
|
—
|
—
|
58 Participants
|
22 Participants
|
89 Participants
|
—
|
—
|
—
|
—
|
—
|
272 Participants
|
283 Participants
|
83 Participants
|
76 Participants
|
84 Participants
|
83 Participants
|
28 Participants
|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
D614G; Day 91: >=4-fold rise
|
—
|
—
|
—
|
53 Participants
|
12 Participants
|
78 Participants
|
—
|
—
|
—
|
—
|
—
|
175 Participants
|
187 Participants
|
57 Participants
|
54 Participants
|
55 Participants
|
48 Participants
|
16 Participants
|
|
Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, and 91
B.1.351; Day 15: >=2-fold rise
|
—
|
—
|
—
|
62 Participants
|
28 Participants
|
88 Participants
|
—
|
—
|
—
|
—
|
—
|
275 Participants
|
269 Participants
|
77 Participants
|
79 Participants
|
85 Participants
|
88 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=330 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
B.1.351: Day 1
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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20.3 titers
Interval 19.7 to 20.8
|
—
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—
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—
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—
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—
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—
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|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
B.1.351: Day 22
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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29.4 titers
Interval 25.7 to 33.5
|
—
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—
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—
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—
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—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
B.1.351: Day 36
|
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
413 titers
Interval 346.0 to 493.0
|
—
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—
|
—
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—
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—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
B.1.351: Day 387
|
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
1033 titers
Interval 686.0 to 1555.0
|
—
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—
|
—
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—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
D614G: Day 1
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—
|
—
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—
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—
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—
|
—
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—
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—
|
—
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—
|
20.3 titers
Interval 19.7 to 21.0
|
—
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—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
D614G: Day 22
|
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—
|
—
|
—
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—
|
—
|
—
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—
|
—
|
—
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—
|
53.3 titers
Interval 44.6 to 63.8
|
—
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—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
D614G: Day 36
|
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—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
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—
|
3658 titers
Interval 3123.0 to 4286.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
D614G: Day 134
|
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
1050 titers
Interval 743.0 to 1486.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
D614G: Day 202
|
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—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
1685 titers
Interval 1142.0 to 2487.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
D614G: Day 292
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1943 titers
Interval 1294.0 to 2918.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
D614G: Day 387
|
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—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
|
1973 titers
Interval 1344.0 to 2897.0
|
—
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—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
B.1.351: Day 134
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
496 titers
Interval 330.0 to 745.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
B.1.351: Day 202
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
671 titers
Interval 441.0 to 1022.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387
B.1.351: Day 292
|
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—
|
—
|
—
|
—
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—
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—
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—
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—
|
—
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—
|
867 titers
Interval 560.0 to 1342.0
|
—
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—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) were analyzed.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=325 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 22: >=2-fold rise
|
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—
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—
|
—
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—
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—
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—
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—
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—
|
—
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—
|
99 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 134: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
134 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 387: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
96 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 387: >=4-fold rise
|
—
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—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
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|
94 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 22: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
88 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 36: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
299 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 36: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
298 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 134: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
131 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 202: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
120 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 202: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
119 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 292: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
108 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 292: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
105 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 387: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
105 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
D614G; Day 387: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
101 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 22: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
39 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 22: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
32 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 36: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
264 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 36: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
251 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 134: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
99 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 134: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
89 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 202: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 202: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
97 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 292: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
98 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387
B.1.351; Day 292: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
91 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387Population: The PPAS is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=330 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.7 titers
Interval 9.91 to 11.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387
Day 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
212 titers
Interval 183.0 to 246.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387
Day 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
24278 titers
Interval 21681.0 to 27185.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387
Day 134
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6593 titers
Interval 4952.0 to 8779.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387
Day 202
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6667 titers
Interval 4833.0 to 9197.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387
Day 292
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6868 titers
Interval 4919.0 to 9587.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387
Day 387
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7112 titers
Interval 5216.0 to 9697.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay. Participants with binding antibodies concentration \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) were analyzed.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=331 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 387: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
117 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 22: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
312 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 22: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
290 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 36: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
302 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 36: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
302 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 134: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
149 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 134: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
148 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 202: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
133 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 202: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
133 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 292: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
123 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 292: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
123 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 387: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
117 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-vaccination on Days 22, 36, 134, 202, 292, and 387Population: The PPAS is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Responders were participants who had baseline values below LLOQ with detectable antibody concentration above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=331 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
94.3 percentage of participants
Interval 91.2 to 96.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
99.7 percentage of participants
Interval 98.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 134
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
98.7 percentage of participants
Interval 95.5 to 99.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 202
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
99.3 percentage of participants
Interval 96.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 292
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
99.3 percentage of participants
Interval 95.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387
Day 387
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
99.2 percentage of participants
Interval 95.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study vaccine administration (Day 1) up to 387 daysPopulation: The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
Blood samples collected from participants were used for serological assessments in the study. Serologically-confirmed SARS-CoV-2 infection was defined as a positive result in a serum sample for antibodies specific to the nucleocapsid of SARS-CoV-2 detected by electrochemiluminescence immunoassay. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=241 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.1 percentage of participants
Interval 8.2 to 16.9
|
10.8 percentage of participants
Interval 7.2 to 15.5
|
14.1 percentage of participants
Interval 10.0 to 19.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.Population: Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Laboratory-confirmed SARS-CoV-2 infection was defined as a positive result for SARS-CoV-2 by nucleic acid amplification test (done by the central laboratory or locally) on at least 1 respiratory sample. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=103 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=127 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=113 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=108 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
n=132 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
n=78 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
n=473 Participants
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=241 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=328 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=378 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=375 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=111 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19
|
25.0 percentage of participants
Interval 16.9 to 34.7
|
29.0 percentage of participants
Interval 20.4 to 38.9
|
9.7 percentage of participants
Interval 4.8 to 17.1
|
24.4 percentage of participants
Interval 17.2 to 32.8
|
12.4 percentage of participants
Interval 6.9 to 19.9
|
10.2 percentage of participants
Interval 5.2 to 17.5
|
0 percentage of participants
Interval 0.0 to 9.3
|
18.4 percentage of participants
Interval 7.7 to 34.3
|
18.9 percentage of participants
Interval 12.6 to 26.7
|
19.2 percentage of participants
Interval 11.2 to 29.7
|
8.2 percentage of participants
Interval 5.9 to 11.1
|
3.3 percentage of participants
Interval 1.4 to 6.5
|
1.7 percentage of participants
Interval 0.5 to 4.2
|
5.4 percentage of participants
Interval 2.9 to 9.0
|
14.0 percentage of participants
Interval 10.5 to 18.3
|
20.9 percentage of participants
Interval 16.9 to 25.4
|
23.5 percentage of participants
Interval 19.3 to 28.1
|
10.8 percentage of participants
Interval 5.7 to 18.1
|
SECONDARY outcome
Timeframe: Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.Population: Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Symptomatic COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=103 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=127 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=113 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=108 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
n=132 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
n=78 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
n=473 Participants
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=241 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=328 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=378 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=375 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=111 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization
|
0 percentage of participants
Interval 0.0 to 3.6
|
0 percentage of participants
Interval 0.0 to 3.6
|
0 percentage of participants
Interval 0.0 to 3.5
|
0.8 percentage of participants
Interval 0.0 to 4.3
|
0 percentage of participants
Interval 0.0 to 3.2
|
0 percentage of participants
Interval 0.0 to 3.4
|
0 percentage of participants
Interval 0.0 to 9.3
|
0 percentage of participants
Interval 0.0 to 9.3
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 4.6
|
0 percentage of participants
Interval 0.0 to 0.8
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 1.1
|
0 percentage of participants
Interval 0.0 to 1.0
|
0.3 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 3.3
|
SECONDARY outcome
Timeframe: Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.Population: Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Severe COVID-19 was defined as COVID-19 with any 1: Any clinical signs of severe illness measured at least on 2 occasions separated by 30 minutes, supplemental oxygen administration for \>1 hour, use of invasive or non-invasive ventilation or Extracorporeal Membrane Oxygenation, clinical diagnosis of respiratory failure, significant acute renal, hepatic, or neurologic dysfunction, shock (defined by systolic blood pressure ˂90 millimeter of mercury (mmHg), or diastolic blood pressure ˂60 mmHg or requiring vasopressors), admission to an intensive care unit, or death. Symptomatic COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=103 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=127 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=113 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=108 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
n=132 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
n=78 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
n=473 Participants
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=241 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=328 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=378 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=375 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=111 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19
|
0 percentage of participants
Interval 0.0 to 3.6
|
0 percentage of participants
Interval 0.0 to 3.6
|
0 percentage of participants
Interval 0.0 to 3.5
|
0 percentage of participants
Interval 0.0 to 2.9
|
0 percentage of participants
Interval 0.0 to 3.2
|
0 percentage of participants
Interval 0.0 to 3.4
|
0 percentage of participants
Interval 0.0 to 9.3
|
0 percentage of participants
Interval 0.0 to 9.3
|
0.8 percentage of participants
Interval 0.0 to 4.1
|
0 percentage of participants
Interval 0.0 to 4.6
|
0 percentage of participants
Interval 0.0 to 0.8
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 1.1
|
0 percentage of participants
Interval 0.0 to 1.0
|
0.3 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 3.3
|
SECONDARY outcome
Timeframe: Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.Population: Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Death associated with COVID-19 was defined as death in a participant with COVID-19 who died within 28 days of the first positive specimen date OR died more than 28 days after the first specimen date and COVID-19 was mentioned as an immediate or underlying cause of death on the death certificate. Symptomatic COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=100 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=103 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=127 Participants
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=113 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=108 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=38 Participants
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
n=132 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
n=78 Participants
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
n=473 Participants
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=240 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=241 Participants
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=328 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=378 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=375 Participants
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=111 Participants
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19
|
0 percentage of participants
Interval 0.0 to 3.6
|
0 percentage of participants
Interval 0.0 to 3.6
|
0 percentage of participants
Interval 0.0 to 3.5
|
0 percentage of participants
Interval 0.0 to 2.9
|
0 percentage of participants
Interval 0.0 to 3.2
|
0 percentage of participants
Interval 0.0 to 3.4
|
0 percentage of participants
Interval 0.0 to 9.3
|
0 percentage of participants
Interval 0.0 to 9.3
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 4.6
|
0 percentage of participants
Interval 0.0 to 0.8
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 1.1
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 3.3
|
Adverse Events
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
Serious events: 2 serious events
Other events: 217 other events
Deaths: 0 deaths
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Serious events: 6 serious events
Other events: 215 other events
Deaths: 0 deaths
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Serious events: 4 serious events
Other events: 219 other events
Deaths: 0 deaths
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
Serious events: 8 serious events
Other events: 281 other events
Deaths: 0 deaths
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
Serious events: 9 serious events
Other events: 328 other events
Deaths: 0 deaths
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Serious events: 11 serious events
Other events: 331 other events
Deaths: 0 deaths
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
Serious events: 3 serious events
Other events: 97 other events
Deaths: 0 deaths
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
Serious events: 1 serious events
Other events: 88 other events
Deaths: 0 deaths
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Serious events: 4 serious events
Other events: 83 other events
Deaths: 0 deaths
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
Serious events: 3 serious events
Other events: 115 other events
Deaths: 0 deaths
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
Serious events: 4 serious events
Other events: 92 other events
Deaths: 0 deaths
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Serious events: 0 serious events
Other events: 97 other events
Deaths: 0 deaths
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Serious events: 1 serious events
Other events: 89 other events
Deaths: 0 deaths
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
Serious events: 3 serious events
Other events: 112 other events
Deaths: 0 deaths
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Serious events: 3 serious events
Other events: 59 other events
Deaths: 0 deaths
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
Serious events: 14 serious events
Other events: 421 other events
Deaths: 1 deaths
Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=240 participants at risk
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=240 participants at risk
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=241 participants at risk
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=328 participants at risk
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=378 participants at risk
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=375 participants at risk
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=113 participants at risk
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=111 participants at risk
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=108 participants at risk
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=127 participants at risk
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=100 participants at risk
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=100 participants at risk
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=103 participants at risk
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=38 participants at risk
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=38 participants at risk
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
n=132 participants at risk
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
n=78 participants at risk
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
n=473 participants at risk
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)
n=4 participants at risk
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)
n=8 participants at risk
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)
n=9 participants at risk
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
n=9 participants at risk
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.93%
1/108 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.79%
1/127 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Nervous system disorders
Alcoholic Seizure
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Stoma Site Pain
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.88%
1/113 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.93%
1/108 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.76%
1/132 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Cardiac disorders
Palpitations
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.88%
1/113 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Nervous system disorders
Cervicobrachial Syndrome
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Nervous system disorders
Loss Of Consciousness
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Nervous system disorders
Motor Neurone Disease
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.3%
1/78 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Eye disorders
Blindness Unilateral
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.88%
1/113 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.88%
1/113 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.53%
2/378 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.3%
1/78 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.41%
1/241 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.90%
1/111 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.76%
1/132 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Abscess
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
25.0%
1/4 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Appendicitis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Covid-19
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.93%
1/108 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.79%
1/127 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.3%
1/78 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Cellulitis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Localised Infection
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Lung Abscess
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Necrotising Fasciitis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Neurological Infection
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.76%
1/132 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Ovarian Abscess
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Periumbilical Abscess
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Pilonidal Disease
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.88%
1/113 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Vascular disorders
Hypertension
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.79%
1/127 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal Neoplasm
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.76%
1/132 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Immune system disorders
Serum Sickness-Like Reaction
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.93%
1/108 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Social circumstances
Loss Of Personal Independence In Daily Activities
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
General disorders
Antidepressant Discontinuation Syndrome
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.79%
1/127 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.93%
1/108 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.97%
1/103 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
25.0%
1/4 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Nervous system disorders
Sciatica
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.41%
1/241 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.41%
1/241 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Breast Carcinoma
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.41%
1/241 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
Other adverse events
| Measure |
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
n=240 participants at risk
Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
n=240 participants at risk
Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
n=241 participants at risk
Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)
n=328 participants at risk
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)
n=378 participants at risk
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=375 participants at risk
Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
n=113 participants at risk
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)
n=111 participants at risk
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=108 participants at risk
Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)
n=127 participants at risk
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)
n=100 participants at risk
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=100 participants at risk
Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
n=103 participants at risk
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)
n=38 participants at risk
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)
n=38 participants at risk
Participants previously vaccinated with J\&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
n=132 participants at risk
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
n=78 participants at risk
Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
n=473 participants at risk
SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.
|
Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)
n=4 participants at risk
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)
n=8 participants at risk
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)
n=9 participants at risk
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.
|
Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
n=9 participants at risk
Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant IM injection between 4 to 10 months after priming vaccine.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.42%
1/240 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.53%
2/378 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.88%
1/113 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.76%
1/132 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.53%
2/378 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.88%
1/113 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
2/473 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.76%
1/132 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.83%
2/240 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.2%
3/241 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.61%
2/328 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.3%
5/378 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.1%
4/375 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.76%
1/132 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.1%
5/473 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Nervous system disorders
Headache
|
58.8%
141/240 • Number of events 195 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
55.8%
134/240 • Number of events 187 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
55.6%
134/241 • Number of events 198 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
39.6%
130/328 • Number of events 133 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
44.2%
167/378 • Number of events 176 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
44.0%
165/375 • Number of events 179 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
41.6%
47/113 • Number of events 49 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
45.0%
50/111 • Number of events 51 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
36.1%
39/108 • Number of events 39 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
35.4%
45/127 • Number of events 46 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
48.0%
48/100 • Number of events 51 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
55.0%
55/100 • Number of events 56 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
35.9%
37/103 • Number of events 37 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
26.3%
10/38 • Number of events 10 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
26.3%
10/38 • Number of events 10 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
38.6%
51/132 • Number of events 52 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
25.6%
20/78 • Number of events 20 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
58.8%
278/473 • Number of events 406 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
50.0%
2/4 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
37.5%
3/8 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
66.7%
6/9 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
33.3%
3/9 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
2/473 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.53%
2/375 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.5%
2/132 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.5%
1/8 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Gastrointestinal disorders
Nausea
|
4.6%
11/240 • Number of events 11 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.9%
7/240 • Number of events 8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.3%
8/241 • Number of events 9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.61%
2/328 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.4%
9/378 • Number of events 9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.1%
8/375 • Number of events 8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.88%
1/113 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.90%
1/111 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.0%
2/100 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.97%
1/103 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
7.9%
3/38 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.76%
1/132 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
5.5%
26/473 • Number of events 30 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Gastrointestinal disorders
Tooth Impacted
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
44.6%
107/240 • Number of events 132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
42.5%
102/240 • Number of events 134 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
43.2%
104/241 • Number of events 131 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
27.7%
91/328 • Number of events 94 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
29.1%
110/378 • Number of events 113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
30.4%
114/375 • Number of events 115 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
27.4%
31/113 • Number of events 32 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
35.1%
39/111 • Number of events 40 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
28.7%
31/108 • Number of events 31 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
17.3%
22/127 • Number of events 22 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
30.0%
30/100 • Number of events 30 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
35.0%
35/100 • Number of events 36 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
23.3%
24/103 • Number of events 24 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
15.8%
6/38 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
18.4%
7/38 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
31.8%
42/132 • Number of events 42 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
23.1%
18/78 • Number of events 18 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
48.2%
228/473 • Number of events 308 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.5%
1/8 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
59.6%
143/240 • Number of events 196 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
56.2%
135/240 • Number of events 176 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
51.0%
123/241 • Number of events 166 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
37.5%
123/328 • Number of events 124 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
38.4%
145/378 • Number of events 148 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
40.8%
153/375 • Number of events 153 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
36.3%
41/113 • Number of events 41 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
43.2%
48/111 • Number of events 51 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
39.8%
43/108 • Number of events 43 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
31.5%
40/127 • Number of events 41 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
36.0%
36/100 • Number of events 38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
54.0%
54/100 • Number of events 54 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
32.0%
33/103 • Number of events 33 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
23.7%
9/38 • Number of events 9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
28.9%
11/38 • Number of events 11 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
46.2%
61/132 • Number of events 61 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
34.6%
27/78 • Number of events 27 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
58.1%
275/473 • Number of events 371 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
50.0%
2/4 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
25.0%
2/8 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
44.4%
4/9 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
44.4%
4/9 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Breast Abscess
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Covid-19
|
2.1%
5/240 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.2%
3/240 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.9%
7/241 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.9%
16/328 • Number of events 16 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
9.0%
34/378 • Number of events 35 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
9.9%
37/375 • Number of events 38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
5.3%
6/113 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.6%
4/111 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
8.3%
9/108 • Number of events 9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.6%
2/127 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
9.0%
9/100 • Number of events 9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
6.0%
6/100 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.9%
5/103 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
15.2%
20/132 • Number of events 20 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
16.7%
13/78 • Number of events 13 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.4%
21/473 • Number of events 21 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Nasopharyngitis
|
0.83%
2/240 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.91%
3/328 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.9%
7/378 • Number of events 9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.53%
2/375 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.9%
5/127 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.0%
2/100 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.3%
3/132 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
7.7%
6/78 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
2/473 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Pharyngitis
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.2%
3/240 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.2%
3/241 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.61%
2/328 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.9%
7/378 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.1%
4/375 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.8%
2/113 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.7%
3/111 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.93%
1/108 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.6%
2/127 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.0%
2/100 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.0%
2/100 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.97%
1/103 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.5%
2/132 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.5%
7/473 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.5%
1/8 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Post-Acute Covid-19 Syndrome
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Sinusitis
|
0.83%
2/240 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.1%
4/378 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.9%
7/375 • Number of events 8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.7%
3/113 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.7%
3/111 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.79%
1/127 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.9%
2/103 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.76%
1/132 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.63%
3/473 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Suspected Covid-19
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.53%
2/378 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.80%
3/375 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.0%
2/100 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
5.3%
2/38 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.0%
4/132 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
2/78 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.80%
3/375 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.90%
1/111 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.85%
4/473 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.2%
3/241 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.91%
3/328 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.3%
5/378 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.53%
2/375 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.8%
2/113 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.90%
1/111 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.7%
4/108 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.9%
3/103 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.76%
1/132 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
2/78 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.85%
4/473 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.5%
1/8 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Urinary Tract Infection
|
1.7%
4/240 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.2%
3/240 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.83%
2/241 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.61%
2/328 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.6%
6/378 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.3%
5/375 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.88%
1/113 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.4%
3/127 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.97%
1/103 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.3%
1/78 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.1%
5/473 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.93%
1/108 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Immune system disorders
Dust Allergy
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/375 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
General disorders
Chills
|
40.4%
97/240 • Number of events 113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
38.8%
93/240 • Number of events 103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
32.0%
77/241 • Number of events 90 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
15.2%
50/328 • Number of events 50 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
19.6%
74/378 • Number of events 75 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
20.5%
77/375 • Number of events 77 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
14.2%
16/113 • Number of events 16 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
20.7%
23/111 • Number of events 23 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
21.3%
23/108 • Number of events 23 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
18.1%
23/127 • Number of events 23 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
23.0%
23/100 • Number of events 23 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
31.0%
31/100 • Number of events 31 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
9.7%
10/103 • Number of events 10 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
13.2%
5/38 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
13.2%
5/38 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
28.8%
38/132 • Number of events 38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
19.2%
15/78 • Number of events 15 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
33.8%
160/473 • Number of events 193 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.5%
1/8 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
General disorders
Fatigue
|
9.2%
22/240 • Number of events 25 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.8%
9/240 • Number of events 11 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
7.1%
17/241 • Number of events 19 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.7%
9/328 • Number of events 9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.5%
17/378 • Number of events 18 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.5%
13/375 • Number of events 13 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.8%
2/113 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.7%
3/111 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.8%
3/108 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.1%
4/127 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
6.0%
6/100 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.9%
4/103 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.0%
4/132 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
8.5%
40/473 • Number of events 46 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
General disorders
Injection Site Erythema
|
11.7%
28/240 • Number of events 31 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
17.1%
41/240 • Number of events 46 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
10.8%
26/241 • Number of events 29 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
9.8%
32/328 • Number of events 32 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
6.1%
23/378 • Number of events 23 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
5.1%
19/375 • Number of events 19 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
7.1%
8/113 • Number of events 8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
6.3%
7/111 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.7%
4/108 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
17.3%
22/127 • Number of events 22 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
8.0%
8/100 • Number of events 8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
9.0%
9/100 • Number of events 9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.9%
5/103 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
7.9%
3/38 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
6.8%
9/132 • Number of events 9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
2/78 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
16.3%
77/473 • Number of events 92 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
General disorders
Injection Site Pain
|
82.9%
199/240 • Number of events 336 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
80.8%
194/240 • Number of events 331 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
83.0%
200/241 • Number of events 339 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
79.0%
259/328 • Number of events 260 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
78.6%
297/378 • Number of events 298 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
80.3%
301/375 • Number of events 302 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
78.8%
89/113 • Number of events 89 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
73.0%
81/111 • Number of events 81 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
69.4%
75/108 • Number of events 75 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
78.7%
100/127 • Number of events 100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
86.0%
86/100 • Number of events 86 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
85.0%
85/100 • Number of events 85 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
77.7%
80/103 • Number of events 80 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
47.4%
18/38 • Number of events 18 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
50.0%
19/38 • Number of events 19 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
72.7%
96/132 • Number of events 96 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
59.0%
46/78 • Number of events 46 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
78.6%
372/473 • Number of events 590 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
100.0%
4/4 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
62.5%
5/8 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
77.8%
7/9 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
33.3%
3/9 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
General disorders
Injection Site Swelling
|
16.7%
40/240 • Number of events 42 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
16.2%
39/240 • Number of events 46 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
15.4%
37/241 • Number of events 41 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
9.8%
32/328 • Number of events 33 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
9.8%
37/378 • Number of events 37 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
6.7%
25/375 • Number of events 25 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
8.8%
10/113 • Number of events 10 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
6.3%
7/111 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.7%
4/108 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
18.9%
24/127 • Number of events 24 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
8.0%
8/100 • Number of events 8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
5.0%
5/100 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
5.8%
6/103 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
7.9%
3/38 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
8.3%
11/132 • Number of events 11 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.8%
3/78 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
15.2%
72/473 • Number of events 86 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.5%
1/8 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
General disorders
Malaise
|
57.5%
138/240 • Number of events 189 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
59.2%
142/240 • Number of events 183 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
60.6%
146/241 • Number of events 190 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
30.8%
101/328 • Number of events 101 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
32.3%
122/378 • Number of events 124 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
32.5%
122/375 • Number of events 126 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
37.2%
42/113 • Number of events 43 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
35.1%
39/111 • Number of events 39 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
30.6%
33/108 • Number of events 33 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
31.5%
40/127 • Number of events 40 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
35.0%
35/100 • Number of events 38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
43.0%
43/100 • Number of events 43 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
30.1%
31/103 • Number of events 31 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
21.1%
8/38 • Number of events 8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
18.4%
7/38 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
46.2%
61/132 • Number of events 61 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
32.1%
25/78 • Number of events 25 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
51.0%
241/473 • Number of events 331 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
25.0%
1/4 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
37.5%
3/8 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
22.2%
2/9 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
33.3%
3/9 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
General disorders
Pyrexia
|
14.2%
34/240 • Number of events 35 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
14.6%
35/240 • Number of events 36 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.0%
29/241 • Number of events 29 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.6%
15/328 • Number of events 16 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.2%
12/378 • Number of events 12 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.8%
18/375 • Number of events 19 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.88%
1/113 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.5%
5/111 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
5.6%
6/108 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.4%
3/127 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.0%
4/100 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
7.0%
7/100 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.9%
2/103 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
8.3%
11/132 • Number of events 11 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.8%
3/78 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
8.9%
42/473 • Number of events 44 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Psychiatric disorders
Depression
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.41%
1/241 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.30%
1/328 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.79%
3/378 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.21%
1/473 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.5%
1/8 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.26%
1/378 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.53%
2/375 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.90%
1/111 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.63%
3/473 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
11.1%
1/9 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
4/240 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.2%
3/240 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.83%
2/241 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.4%
8/328 • Number of events 8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.4%
13/378 • Number of events 14 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.2%
12/375 • Number of events 12 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.5%
4/113 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.7%
3/111 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.7%
4/108 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
5.5%
7/127 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.0%
4/100 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.0%
4/100 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.97%
1/103 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
5.3%
2/38 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.0%
4/132 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.3%
1/78 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
7.0%
33/473 • Number of events 36 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.5%
1/8 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.42%
1/240 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.83%
2/240 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.61%
2/328 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.79%
3/378 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.79%
1/127 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.0%
1/100 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.0%
2/100 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.5%
7/473 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.5%
1/8 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.83%
2/240 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.7%
4/241 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.2%
4/328 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.6%
6/378 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.3%
5/375 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.88%
1/113 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.90%
1/111 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.9%
2/108 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.6%
2/127 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.0%
3/100 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.0%
4/100 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.7%
13/473 • Number of events 14 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.5%
1/8 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.7%
4/240 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.7%
4/240 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.41%
1/241 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.8%
6/328 • Number of events 6 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.4%
9/378 • Number of events 10 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.9%
11/375 • Number of events 11 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
3.5%
4/113 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.7%
3/111 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.8%
3/108 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.6%
2/127 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
5.0%
5/100 • Number of events 5 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.0%
2/100 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.97%
1/103 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.76%
1/132 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
4.7%
22/473 • Number of events 24 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
12.5%
1/8 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/240 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/241 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/328 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/378 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.27%
1/375 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/111 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/108 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/127 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/132 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/78 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/473 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
25.0%
1/4 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
|
General disorders
Injection Site Pruritus
|
2.9%
7/240 • Number of events 7 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
5.8%
14/240 • Number of events 15 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.5%
6/241 • Number of events 8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.2%
4/328 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.1%
4/378 • Number of events 4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.53%
2/375 • Number of events 2 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/113 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.90%
1/111 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.8%
3/108 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.79%
1/127 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/100 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/103 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/38 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.6%
1/38 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.3%
3/132 • Number of events 3 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
1.3%
1/78 • Number of events 1 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
2.7%
13/473 • Number of events 15 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/4 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/8 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
|
0.00%
0/9 • Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER