Trial Outcomes & Findings for Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (NCT NCT04889209)
NCT ID: NCT04889209
Last Updated: 2025-04-20
Results Overview
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against D614G
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
867 participants
Primary outcome timeframe
Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
Results posted on
2025-04-20
Participant Flow
Participants that enrolled in Cohort 1 Group 4E and then rolled over into Cohort 1 Group 15E signed separate informed consent documents prior to successful enrollment in each group. Cohort 1Group 15E referred to as Co 1 Gr 15E below.
Cohort 1 provided rapid information about the safety, reactogenicity, and immunogenicity of delayed boost in a previously EUA-dosed group. Cohort 2 was an adaptive cohort that was vaccine-naïve that evaluated the safety, reactogenicity and immunogenicity of EUA-dosed vaccine followed by delayed boost.
Participant milestones
| Measure |
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose). N = 50
mRNA-1273: 0.5mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n ˜ 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10\^10 vp stratified with two age ranges of 18-55 years (n=˜ 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA- 1273 N = 50
mRNA-1273: 0.25 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: 0.25 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: 0.25 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10\^10 vp for one or two doses stratified with two age ranges of 18-55 years (n= 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
|
Cohort 2
Prospective cohort with naïve to COVID-19 vaccine and infection participants \>/= 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval N=250
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
mRNA-1273.222: Formulated the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
All Cohorts Except 15E
STARTED
|
53
|
51
|
50
|
50
|
49
|
51
|
53
|
51
|
50
|
43
|
50
|
47
|
50
|
46
|
0
|
16
|
31
|
106
|
|
All Cohorts Except 15E
COMPLETED
|
50
|
47
|
47
|
31
|
41
|
46
|
48
|
46
|
45
|
35
|
44
|
39
|
43
|
44
|
0
|
10
|
22
|
56
|
|
All Cohorts Except 15E
NOT COMPLETED
|
3
|
4
|
3
|
19
|
8
|
5
|
5
|
5
|
5
|
8
|
6
|
8
|
7
|
2
|
0
|
6
|
9
|
50
|
|
Direct Enroll, Rollover to Co 1 Gr 15E
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
0
|
0
|
0
|
|
Direct Enroll, Rollover to Co 1 Gr 15E
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
18
|
0
|
0
|
0
|
|
Direct Enroll, Rollover to Co 1 Gr 15E
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose). N = 50
mRNA-1273: 0.5mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n ˜ 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10\^10 vp stratified with two age ranges of 18-55 years (n=˜ 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA- 1273 N = 50
mRNA-1273: 0.25 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: 0.25 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: 0.25 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10\^10 vp for one or two doses stratified with two age ranges of 18-55 years (n= 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
|
Cohort 2
Prospective cohort with naïve to COVID-19 vaccine and infection participants \>/= 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval N=250
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
mRNA-1273.222: Formulated the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
All Cohorts Except 15E
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
All Cohorts Except 15E
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
All Cohorts Except 15E
Lost to Follow-up
|
0
|
0
|
1
|
2
|
4
|
1
|
0
|
1
|
2
|
2
|
2
|
4
|
2
|
2
|
0
|
5
|
5
|
28
|
|
All Cohorts Except 15E
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
All Cohorts Except 15E
Withdrawal by Subject
|
1
|
1
|
2
|
5
|
2
|
3
|
3
|
1
|
3
|
3
|
3
|
3
|
3
|
0
|
0
|
1
|
3
|
16
|
|
All Cohorts Except 15E
Participant relocated, no follow-up planned
|
2
|
2
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
All Cohorts Except 15E
Cohort 1 group 4E Participant rolled over into Cohort 1 group 15E
|
0
|
0
|
0
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
All Cohorts Except 15E
Participant unable to adhere to visit schedule
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
All Cohorts Except 15E
Became ineligible after enrollment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
All Cohorts Except 15E
Confirmed SARS CoV-2 infection
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
|
Direct Enroll, Rollover to Co 1 Gr 15E
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
Baseline Characteristics
All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
Baseline characteristics by cohort
| Measure |
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n ˜ 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (delayed boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (delayed boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (delayed boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10\^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=53 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10\^10 vp stratified with two age ranges of 18-55 years (n=˜ 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=43 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=47 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10\^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA- 1273 N = 50
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=20 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10\^10 vp for one or two doses stratified with two age ranges of 18-55 years (n= 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=16 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=31 Participants
Adaptive design cohort with participants that previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume \[w/v\]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
|
Cohort 2
n=106 Participants
Prospective cohort with naïve to COVID-19 vaccine and infection participants \>/= 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval N=250
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
mRNA-1273.222: Formulated the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273.
|
Total
n=867 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
All Cohorts except 15E
|
56.8 years
STANDARD_DEVIATION 14.5 • n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
53.1 years
STANDARD_DEVIATION 16.2 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
54.8 years
STANDARD_DEVIATION 17.4 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
50.1 years
STANDARD_DEVIATION 13.9 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
49.9 years
STANDARD_DEVIATION 16.8 • n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
50.3 years
STANDARD_DEVIATION 15.4 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
47.7 years
STANDARD_DEVIATION 14.5 • n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
54.3 years
STANDARD_DEVIATION 16.8 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
50.4 years
STANDARD_DEVIATION 17.9 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
49.4 years
STANDARD_DEVIATION 13.6 • n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
48.3 years
STANDARD_DEVIATION 16.8 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
48.3 years
STANDARD_DEVIATION 13.4 • n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
52.9 years
STANDARD_DEVIATION 17.2 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
47.8 years
STANDARD_DEVIATION 16.4 • n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
48.4 years
STANDARD_DEVIATION 14.7 • n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
43.2 years
STANDARD_DEVIATION 11.9 • n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
39.5 years
STANDARD_DEVIATION 13.6 • n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
49.3 years
STANDARD_DEVIATION 16.0 • n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Age, Continuous
Cohort 1 Group 15E
|
—
|
—
|
—
|
—
|
—
|
—
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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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50.3 years
STANDARD_DEVIATION 15.9 • n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
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—
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—
|
50.3 years
STANDARD_DEVIATION 15.9 • n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Sex: Female, Male
All Cohorts Except 15E · Female
|
26 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
32 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
29 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
16 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
23 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
29 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
26 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
23 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
22 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
23 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
21 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
24 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
6 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
16 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
55 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
425 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Sex: Female, Male
All Cohorts Except 15E · Male
|
27 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
19 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
21 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
23 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
33 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
28 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
24 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
25 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
21 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
26 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
26 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
19 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
10 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
15 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
51 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
422 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Sex: Female, Male
Cohort 1 Group 15E · Female
|
—
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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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—
|
9 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
9 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Sex: Female, Male
Cohort 1 Group 15E · Male
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
11 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Ethnicity (NIH/OMB)
All Cohorts Except 15E · Hispanic or Latino
|
4 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
4 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
3 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
3 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
5 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
2 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
3 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
5 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
41 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Ethnicity (NIH/OMB)
All Cohorts Except 15E · Not Hispanic or Latino
|
49 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
46 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
47 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
47 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
49 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
48 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
51 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
50 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
45 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
42 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
47 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
46 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
48 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
45 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
14 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
101 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
802 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Ethnicity (NIH/OMB)
All Cohorts Except 15E · Unknown or Not Reported
|
0 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
0 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
4 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Ethnicity (NIH/OMB)
Cohort 1 Group 15E · Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
2 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Ethnicity (NIH/OMB)
Cohort 1 Group 15E · Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
17 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Ethnicity (NIH/OMB)
Cohort 1 Group 15E · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
1 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
All Cohorts Except 15E · American Indian or Alaska Native
|
0 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
0 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
All Cohorts Except 15E · Black or African American
|
1 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
3 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
3 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
4 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
5 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
10 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
32 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
67 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
All Cohorts Except 15E · Asian
|
4 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
5 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
4 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
3 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
5 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
6 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
6 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
7 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
4 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
7 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
0 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
4 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
62 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
All Cohorts Except 15E · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
0 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
All Cohorts Except 15E · White
|
46 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
41 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
43 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
44 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
43 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
40 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
51 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
47 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
43 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
38 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
37 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
40 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
37 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
35 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
10 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
15 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
70 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
680 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
All Cohorts Except 15E · Multi-Racial
|
1 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
3 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
3 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
4 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
3 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
4 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
3 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
1 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
2 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
31 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
All Cohorts Except 15E · Not Reported
|
0 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
0 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
3 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
All Cohorts Except 15E · Other
|
1 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
0 Participants
n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
0 Participants
n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
1 Participants
n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
4 Participants
n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
Cohort 1 Group 15E · American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
0 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
Cohort 1 Group 15E · Asian
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
0 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
Cohort 1 Group 15E · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
0 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
Cohort 1 Group 15E · Black or African American
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
3 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
Cohort 1 Group 15E · White
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
13 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
Cohort 1 Group 15E · Multi-Racial
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
4 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
Cohort 1 Group 15E · Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
0 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Race/Ethnicity, Customized
Cohort 1 Group 15E · Other
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
0 Participants
n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Height
All Cohorts except 15E
|
170.595 cm
STANDARD_DEVIATION 10.875 • n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
168.104 cm
STANDARD_DEVIATION 10.253 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
169.330 cm
STANDARD_DEVIATION 10.421 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
171.636 cm
STANDARD_DEVIATION 10.273 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
172.547 cm
STANDARD_DEVIATION 9.613 • n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
170.231 cm
STANDARD_DEVIATION 10.639 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
171.604 cm
STANDARD_DEVIATION 9.582 • n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
170.448 cm
STANDARD_DEVIATION 9.331 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
171.115 cm
STANDARD_DEVIATION 9.965 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
171.344 cm
STANDARD_DEVIATION 9.844 • n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
172.266 cm
STANDARD_DEVIATION 10.431 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
173.072 cm
STANDARD_DEVIATION 10.633 • n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
169.714 cm
STANDARD_DEVIATION 11.691 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
169.990 cm
STANDARD_DEVIATION 8.949 • n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
172.038 cm
STANDARD_DEVIATION 10.676 • n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
170.835 cm
STANDARD_DEVIATION 10.766 • n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
171.326 cm
STANDARD_DEVIATION 10.134 • n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
170.927 cm
STANDARD_DEVIATION 10.203 • n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Height
Cohort 1 Group 15E
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
172.151 cm
STANDARD_DEVIATION 6.268 • n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
172.151 cm
STANDARD_DEVIATION 6.268 • n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Weight
All Groups Except 15E
|
82.474 kg
STANDARD_DEVIATION 22.586 • n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
79.960 kg
STANDARD_DEVIATION 17.572 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
82.877 kg
STANDARD_DEVIATION 23.870 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
80.705 kg
STANDARD_DEVIATION 18.437 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
83.536 kg
STANDARD_DEVIATION 20.798 • n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
80.229 kg
STANDARD_DEVIATION 17.936 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
78.743 kg
STANDARD_DEVIATION 24.710 • n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
80.766 kg
STANDARD_DEVIATION 17.668 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
80.935 kg
STANDARD_DEVIATION 18.560 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
79.649 kg
STANDARD_DEVIATION 18.894 • n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
80.050 kg
STANDARD_DEVIATION 19.014 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
81.383 kg
STANDARD_DEVIATION 18.374 • n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
76.205 kg
STANDARD_DEVIATION 18.407 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
78.521 kg
STANDARD_DEVIATION 18.593 • n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
79.03 kg
STANDARD_DEVIATION 14.60 • n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
93.17 kg
STANDARD_DEVIATION 26.77 • n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
88.771 kg
STANDARD_DEVIATION 21.467 • n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
81.935 kg
STANDARD_DEVIATION 20.458 • n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
Weight
Cohort 1 Group 15E
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
88.15 kg
STANDARD_DEVIATION 20.08 • n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
88.15 kg
STANDARD_DEVIATION 20.08 • n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
BMI
All Cohorts except 15E
|
28.30 kg/m2
STANDARD_DEVIATION 7.94 • n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
28.34 kg/m2
STANDARD_DEVIATION 6.10 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
28.79 kg/m2
STANDARD_DEVIATION 7.45 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27.32 kg/m2
STANDARD_DEVIATION 5.55 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27.97 kg/m2
STANDARD_DEVIATION 6.40 • n=49 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27.58 kg/m2
STANDARD_DEVIATION 5.06 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
26.57 kg/m2
STANDARD_DEVIATION 7.64 • n=53 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27.71 kg/m2
STANDARD_DEVIATION 5.21 • n=51 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27.76 kg/m2
STANDARD_DEVIATION 6.67 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
26.96 kg/m2
STANDARD_DEVIATION 5.02 • n=43 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27.02 kg/m2
STANDARD_DEVIATION 6.61 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27.01 kg/m2
STANDARD_DEVIATION 4.97 • n=47 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
26.37 kg/m2
STANDARD_DEVIATION 5.53 • n=50 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27.13 kg/m2
STANDARD_DEVIATION 6.08 • n=46 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
26.62 kg/m2
STANDARD_DEVIATION 4.21 • n=16 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
31.66 kg/m2
STANDARD_DEVIATION 7.73 • n=31 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
30.36 kg/m2
STANDARD_DEVIATION 7.52 • n=106 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
27.99 kg/m2
STANDARD_DEVIATION 6.54 • n=847 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
|
BMI
Cohort 1 Group 15E
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
29.60 kg/m2
STANDARD_DEVIATION 5.84 • n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
—
|
—
|
—
|
29.60 kg/m2
STANDARD_DEVIATION 5.84 • n=20 Participants • All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
|
PRIMARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Geometric Mean AUC of Antibody Against WA-1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. Units are Electrochemiluminescence (ECL) Signal x 1/dilution (integrated).
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=42 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1
Day 273
|
24139.14 Arbitrary Unit*1/dilution
Interval 16057.25 to 36288.79
|
46337.63 Arbitrary Unit*1/dilution
Interval 39831.8 to 53906.06
|
33341.39 Arbitrary Unit*1/dilution
Interval 26883.01 to 41351.34
|
43013.25 Arbitrary Unit*1/dilution
Interval 30391.43 to 60877.02
|
25844.56 Arbitrary Unit*1/dilution
Interval 19147.02 to 34884.88
|
38808.82 Arbitrary Unit*1/dilution
Interval 32552.83 to 46267.09
|
25855.31 Arbitrary Unit*1/dilution
Interval 19486.0 to 34306.52
|
45909.39 Arbitrary Unit*1/dilution
Interval 40465.43 to 52085.74
|
30573.66 Arbitrary Unit*1/dilution
Interval 21592.2 to 43291.02
|
—
|
—
|
—
|
34368.23 Arbitrary Unit*1/dilution
Interval 27632.83 to 42745.35
|
20331.28 Arbitrary Unit*1/dilution
Interval 14197.27 to 29115.54
|
34556.56 Arbitrary Unit*1/dilution
Interval 27979.01 to 42680.42
|
36651.20 Arbitrary Unit*1/dilution
Interval 30142.19 to 44565.78
|
35196.75 Arbitrary Unit*1/dilution
Interval 25622.52 to 48348.54
|
—
|
|
Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1
Day 15
|
—
|
—
|
—
|
50130.93 Arbitrary Unit*1/dilution
Interval 44100.34 to 56986.18
|
—
|
—
|
—
|
—
|
44295.72 Arbitrary Unit*1/dilution
Interval 39894.34 to 49182.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
22969.71 Arbitrary Unit*1/dilution
Interval 15905.34 to 33171.74
|
—
|
|
Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1
Day 1, Pre-Dose
|
2926.70 Arbitrary Unit*1/dilution
Interval 2128.92 to 4023.44
|
20715.09 Arbitrary Unit*1/dilution
Interval 17568.48 to 24425.28
|
11448.89 Arbitrary Unit*1/dilution
Interval 9385.87 to 13965.38
|
17749.73 Arbitrary Unit*1/dilution
Interval 10968.1 to 28724.48
|
4198.32 Arbitrary Unit*1/dilution
Interval 2966.41 to 5941.81
|
12104.83 Arbitrary Unit*1/dilution
Interval 9827.34 to 14910.12
|
2314.29 Arbitrary Unit*1/dilution
Interval 1712.29 to 3127.94
|
13480.35 Arbitrary Unit*1/dilution
Interval 10994.14 to 16528.79
|
13682.64 Arbitrary Unit*1/dilution
Interval 8804.3 to 21263.99
|
2940.97 Arbitrary Unit*1/dilution
Interval 2349.82 to 3680.83
|
26101.97 Arbitrary Unit*1/dilution
Interval 22876.53 to 29782.18
|
14223.28 Arbitrary Unit*1/dilution
Interval 11259.42 to 17967.32
|
11549.69 Arbitrary Unit*1/dilution
Interval 9316.31 to 14318.48
|
3790.32 Arbitrary Unit*1/dilution
Interval 2857.23 to 5028.13
|
23437.84 Arbitrary Unit*1/dilution
Interval 20581.58 to 26690.49
|
8895.46 Arbitrary Unit*1/dilution
Interval 7293.62 to 10849.1
|
4423.99 Arbitrary Unit*1/dilution
Interval 2495.03 to 7844.25
|
—
|
|
Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1
Day 29
|
11221.56 Arbitrary Unit*1/dilution
Interval 9150.39 to 13761.55
|
51277.70 Arbitrary Unit*1/dilution
Interval 48148.69 to 54610.04
|
47695.55 Arbitrary Unit*1/dilution
Interval 42234.81 to 53862.32
|
46053.86 Arbitrary Unit*1/dilution
Interval 38716.71 to 54781.48
|
49577.25 Arbitrary Unit*1/dilution
Interval 45525.67 to 53989.4
|
60745.09 Arbitrary Unit*1/dilution
Interval 59183.24 to 62348.16
|
46758.48 Arbitrary Unit*1/dilution
Interval 44178.01 to 49489.67
|
59407.62 Arbitrary Unit*1/dilution
Interval 57066.79 to 61844.47
|
42857.80 Arbitrary Unit*1/dilution
Interval 38031.14 to 48297.02
|
46396.64 Arbitrary Unit*1/dilution
Interval 43261.81 to 49758.63
|
58170.70 Arbitrary Unit*1/dilution
Interval 56455.39 to 59938.12
|
53826.28 Arbitrary Unit*1/dilution
Interval 50861.98 to 56963.33
|
41335.27 Arbitrary Unit*1/dilution
Interval 37689.91 to 46688.47
|
42955.92 Arbitrary Unit*1/dilution
Interval 39545.96 to 46659.91
|
58564.74 Arbitrary Unit*1/dilution
Interval 56547.13 to 60654.33
|
58728.16 Arbitrary Unit*1/dilution
Interval 56832.02 to 60687.56
|
20950.53 Arbitrary Unit*1/dilution
Interval 13923.52 to 31523.99
|
—
|
|
Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1
Day 91
|
8387.48 Arbitrary Unit*1/dilution
Interval 6856.62 to 10260.14
|
49339.52 Arbitrary Unit*1/dilution
Interval 45671.1 to 53302.59
|
38564.83 Arbitrary Unit*1/dilution
Interval 35140.64 to 42322.68
|
44220.57 Arbitrary Unit*1/dilution
Interval 35889.03 to 54486.24
|
34007.68 Arbitrary Unit*1/dilution
Interval 29150.94 to 39673.58
|
48892.87 Arbitrary Unit*1/dilution
Interval 45640.19 to 52377.36
|
30620.81 Arbitrary Unit*1/dilution
Interval 27303.51 to 34341.16
|
51633.60 Arbitrary Unit*1/dilution
Interval 48114.98 to 55409.53
|
38320.95 Arbitrary Unit*1/dilution
Interval 30415.62 to 48280.95
|
31618.63 Arbitrary Unit*1/dilution
Interval 28253.56 to 35384.5
|
47163.57 Arbitrary Unit*1/dilution
Interval 44641.79 to 49827.82
|
42511.10 Arbitrary Unit*1/dilution
Interval 38846.21 to 46521.74
|
39977.61 Arbitrary Unit*1/dilution
Interval 36170.95 to 44184.88
|
28807.64 Arbitrary Unit*1/dilution
Interval 25302.68 to 32798.11
|
48358.86 Arbitrary Unit*1/dilution
Interval 45418.4 to 51489.69
|
47222.88 Arbitrary Unit*1/dilution
Interval 43132.31 to 51701.38
|
15093.62 Arbitrary Unit*1/dilution
Interval 9651.71 to 23603.84
|
—
|
|
Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1
Day 181
|
12896.71 Arbitrary Unit*1/dilution
Interval 9184.15 to 18110.0
|
45772.37 Arbitrary Unit*1/dilution
Interval 40542.78 to 51676.52
|
28640.42 Arbitrary Unit*1/dilution
Interval 24374.56 to 33652.85
|
38984.11 Arbitrary Unit*1/dilution
Interval 26907.57 to 56480.79
|
27894.31 Arbitrary Unit*1/dilution
Interval 22343.65 to 34823.87
|
35751.04 Arbitrary Unit*1/dilution
Interval 31937.3 to 40020.19
|
20954.21 Arbitrary Unit*1/dilution
Interval 17277.95 to 25412.67
|
42109.89 Arbitrary Unit*1/dilution
Interval 37225.34 to 47635.38
|
31129.10 Arbitrary Unit*1/dilution
Interval 22535.88 to 42999.02
|
17458.61 Arbitrary Unit*1/dilution
Interval 14702.34 to 20731.61
|
32351.89 Arbitrary Unit*1/dilution
Interval 29022.64 to 36063.04
|
28690.99 Arbitrary Unit*1/dilution
Interval 24256.45 to 33936.24
|
35430.22 Arbitrary Unit*1/dilution
Interval 30680.95 to 40914.66
|
19889.46 Arbitrary Unit*1/dilution
Interval 15887.09 to 24900.12
|
37981.19 Arbitrary Unit*1/dilution
Interval 33589.63 to 42946.91
|
40408.83 Arbitrary Unit*1/dilution
Interval 35846.96 to 45551.24
|
20826.02 Arbitrary Unit*1/dilution
Interval 12090.96 to 35871.7
|
—
|
|
Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1
Day 366
|
26224.15 Arbitrary Unit*1/dilution
Interval 18621.08 to 36931.58
|
47342.92 Arbitrary Unit*1/dilution
Interval 41185.51 to 54420.89
|
36487.96 Arbitrary Unit*1/dilution
Interval 30305.41 to 43931.79
|
49916.77 Arbitrary Unit*1/dilution
Interval 38057.55 to 65471.49
|
38505.13 Arbitrary Unit*1/dilution
Interval 30222.07 to 49058.36
|
46309.04 Arbitrary Unit*1/dilution
Interval 39804.39 to 53876.66
|
32151.88 Arbitrary Unit*1/dilution
Interval 25389.43 to 40715.52
|
47851.89 Arbitrary Unit*1/dilution
Interval 42364.97 to 54049.45
|
37897.76 Arbitrary Unit*1/dilution
Interval 26382.63 to 54438.84
|
16279.54 Arbitrary Unit*1/dilution
Interval 11655.92 to 22737.22
|
30329.85 Arbitrary Unit*1/dilution
Interval 23407.8 to 39298.85
|
33164.24 Arbitrary Unit*1/dilution
Interval 30222.07 to 49058.36
|
41154.35 Arbitrary Unit*1/dilution
Interval 34353.09 to 49302.13
|
34832.97 Arbitrary Unit*1/dilution
Interval 27370.95 to 44329.33
|
37066.79 Arbitrary Unit*1/dilution
Interval 30111.92 to 45628.0
|
44965.48 Arbitrary Unit*1/dilution
Interval 38241.12 to 52872.25
|
31119.43 Arbitrary Unit*1/dilution
Interval 22820.78 to 42435.85
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Geometric Mean AUC of Antibody Against B.1.351 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=42 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1
Day 91
|
2898.58 Arbitrary Unit*1/dilution
Interval 2337.97 to 3593.63
|
25421.46 Arbitrary Unit*1/dilution
Interval 21951.5 to 29439.92
|
20818.34 Arbitrary Unit*1/dilution
Interval 18206.42 to 23804.98
|
26478.42 Arbitrary Unit*1/dilution
Interval 19068.38 to 36768.01
|
19023.81 Arbitrary Unit*1/dilution
Interval 15438.33 to 23442.0
|
33082.45 Arbitrary Unit*1/dilution
Interval 29822.29 to 36699.02
|
15586.43 Arbitrary Unit*1/dilution
Interval 13174.8 to 18439.51
|
33595.91 Arbitrary Unit*1/dilution
Interval 30011.95 to 37607.86
|
24620.13 Arbitrary Unit*1/dilution
Interval 18379.45 to 32979.82
|
15169.94 Arbitrary Unit*1/dilution
Interval 13027.23 to 17665.07
|
27671.50 Arbitrary Unit*1/dilution
Interval 25424.22 to 30117.43
|
26254.53 Arbitrary Unit*1/dilution
Interval 23442.83 to 29403.47
|
19134.05 Arbitrary Unit*1/dilution
Interval 16141.1 to 22681.95
|
14117.54 Arbitrary Unit*1/dilution
Interval 12056.77 to 16530.55
|
27268.18 Arbitrary Unit*1/dilution
Interval 24809.44 to 29970.6
|
31546.58 Arbitrary Unit*1/dilution
Interval 27868.57 to 35710.0
|
6723.73 Arbitrary Unit*1/dilution
Interval 3990.92 to 11327.86
|
—
|
|
Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1
Day 181
|
5927.70 Arbitrary Unit*1/dilution
Interval 3823.13 to 9190.78
|
25363.92 Arbitrary Unit*1/dilution
Interval 20471.42 to 31425.7
|
15227.63 Arbitrary Unit*1/dilution
Interval 12263.23 to 18908.62
|
22911.81 Arbitrary Unit*1/dilution
Interval 13567.88 to 38690.73
|
14797.17 Arbitrary Unit*1/dilution
Interval 11037.51 to 19837.46
|
21187.80 Arbitrary Unit*1/dilution
Interval 18057.84 to 24860.28
|
9654.27 Arbitrary Unit*1/dilution
Interval 7577.47 to 12300.25
|
24777.00 Arbitrary Unit*1/dilution
Interval 20635.24 to 29750.06
|
19694.67 Arbitrary Unit*1/dilution
Interval 13281.97 to 29203.48
|
7471.43 Arbitrary Unit*1/dilution
Interval 6153.36 to 9071.84
|
15948.35 Arbitrary Unit*1/dilution
Interval 13679.33 to 18593.74
|
15594.79 Arbitrary Unit*1/dilution
Interval 12707.95 to 19137.42
|
17961.00 Arbitrary Unit*1/dilution
Interval 14221.54 to 22683.74
|
9676.46 Arbitrary Unit*1/dilution
Interval 7422.32 to 12615.18
|
20240.62 Arbitrary Unit*1/dilution
Interval 17078.35 to 23988.42
|
24443.88 Arbitrary Unit*1/dilution
Interval 20492.73 to 29156.85
|
10607.87 Arbitrary Unit*1/dilution
Interval 5511.13 to 20418.12
|
—
|
|
Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1
Day 1, Pre-Dose
|
954.30 Arbitrary Unit*1/dilution
Interval 685.96 to 1327.62
|
8076.74 Arbitrary Unit*1/dilution
Interval 6708.27 to 9724.36
|
5572.24 Arbitrary Unit*1/dilution
Interval 4706.89 to 6596.69
|
8253.24 Arbitrary Unit*1/dilution
Interval 4414.58 to 15429.76
|
1157.98 Arbitrary Unit*1/dilution
Interval 829.29 to 1616.95
|
4842.69 Arbitrary Unit*1/dilution
Interval 3832.48 to 6119.18
|
814.66 Arbitrary Unit*1/dilution
Interval 600.25 to 1105.67
|
5850.30 Arbitrary Unit*1/dilution
Interval 4659.22 to 7345.86
|
7414.32 Arbitrary Unit*1/dilution
Interval 4422.53 to 12430.01
|
942.30 Arbitrary Unit*1/dilution
Interval 744.4 to 1192.81
|
11013.62 Arbitrary Unit*1/dilution
Interval 9254.21 to 13107.54
|
6047.85 Arbitrary Unit*1/dilution
Interval 4839.0 to 7558.69
|
5201.78 Arbitrary Unit*1/dilution
Interval 4221.65 to 6409.48
|
1402.70 Arbitrary Unit*1/dilution
Interval 1044.97 to 1882.89
|
10079.24 Arbitrary Unit*1/dilution
Interval 8831.54 to 11503.21
|
4007.33 Arbitrary Unit*1/dilution
Interval 3251.91 to 4938.22
|
1525.71 Arbitrary Unit*1/dilution
Interval 874.39 to 2662.2
|
—
|
|
Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1
Day 15
|
—
|
—
|
—
|
35359.98 Arbitrary Unit*1/dilution
Interval 29312.98 to 42654.43
|
—
|
—
|
—
|
—
|
29907.22 Arbitrary Unit*1/dilution
Interval 25349.53 to 35284.34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12221.52 Arbitrary Unit*1/dilution
Interval 7549.8 to 19784.06
|
—
|
|
Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1
Day 29
|
4374.91 Arbitrary Unit*1/dilution
Interval 3521.79 to 5434.68
|
28074.29 Arbitrary Unit*1/dilution
Interval 24899.01 to 31654.51
|
30475.16 Arbitrary Unit*1/dilution
Interval 26260.31 to 35366.51
|
30089.60 Arbitrary Unit*1/dilution
Interval 22836.66 to 39646.08
|
30963.49 Arbitrary Unit*1/dilution
Interval 26929.55 to 35601.69
|
42846.74 Arbitrary Unit*1/dilution
Interval 40742.39 to 45059.79
|
26189.91 Arbitrary Unit*1/dilution
Interval 23594.3 to 29071.07
|
39348.91 Arbitrary Unit*1/dilution
Interval 36296.61 to 42657.88
|
28612.56 Arbitrary Unit*1/dilution
Interval 23973.55 to 34149.23
|
26285.49 Arbitrary Unit*1/dilution
Interval 23490.65 to 29412.84
|
36774.49 Arbitrary Unit*1/dilution
Interval 34659.48 to 39018.56
|
34955.90 Arbitrary Unit*1/dilution
Interval 32009.83 to 38173.12
|
21791.31 Arbitrary Unit*1/dilution
Interval 18762.06 to 25309.66
|
25833.88 Arbitrary Unit*1/dilution
Interval 22966.5 to 29059.26
|
38209.76 Arbitrary Unit*1/dilution
Interval 36117.55 to 40423.17
|
38613.53 Arbitrary Unit*1/dilution
Interval 35586.82 to 41897.66
|
10675.96 Arbitrary Unit*1/dilution
Interval 6334.38 to 17993.24
|
—
|
|
Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1
Day 273
|
13419.30 Arbitrary Unit*1/dilution
Interval 7963.82 to 22611.94
|
25606.61 Arbitrary Unit*1/dilution
Interval 19930.24 to 32899.67
|
19883.25 Arbitrary Unit*1/dilution
Interval 15075.44 to 26224.36
|
26049.67 Arbitrary Unit*1/dilution
Interval 16237.15 to 41792.13
|
13779.96 Arbitrary Unit*1/dilution
Interval 9225.46 to 20582.97
|
24867.46 Arbitrary Unit*1/dilution
Interval 19656.38 to 31460.05
|
13945.30 Arbitrary Unit*1/dilution
Interval 9762.02 to 19921.21
|
28289.22 Arbitrary Unit*1/dilution
Interval 23181.18 to 34522.83
|
19442.79 Arbitrary Unit*1/dilution
Interval 13083.34 to 28893.39
|
—
|
—
|
—
|
18677.11 Arbitrary Unit*1/dilution
Interval 13530.91 to 25780.54
|
11200.14 Arbitrary Unit*1/dilution
Interval 7325.04 to 17125.25
|
19035.58 Arbitrary Unit*1/dilution
Interval 14338.55 to 25271.26
|
23144.27 Arbitrary Unit*1/dilution
Interval 18170.67 to 29479.22
|
20832.94 Arbitrary Unit*1/dilution
Interval 13987.12 to 31029.36
|
—
|
|
Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1
Day 366
|
14562.44 Arbitrary Unit*1/dilution
Interval 9567.57 to 22164.95
|
26463.44 Arbitrary Unit*1/dilution
Interval 20623.05 to 33957.8
|
22385.67 Arbitrary Unit*1/dilution
Interval 17470.21 to 28684.16
|
31999.19 Arbitrary Unit*1/dilution
Interval 21018.85 to 48715.72
|
23311.90 Arbitrary Unit*1/dilution
Interval 17260.46 to 31484.94
|
31525.58 Arbitrary Unit*1/dilution
Interval 25510.38 to 38959.13
|
17859.94 Arbitrary Unit*1/dilution
Interval 13214.83 to 24137.84
|
30792.74 Arbitrary Unit*1/dilution
Interval 25742.82 to 36833.29
|
25344.25 Arbitrary Unit*1/dilution
Interval 16274.01 to 39469.76
|
8213.69 Arbitrary Unit*1/dilution
Interval 5532.02 to 12195.31
|
17151.09 Arbitrary Unit*1/dilution
Interval 12218.59 to 24074.79
|
19820.85 Arbitrary Unit*1/dilution
Interval 14567.28 to 26969.07
|
24277.42 Arbitrary Unit*1/dilution
Interval 18615.37 to 31661.62
|
21177.37 Arbitrary Unit*1/dilution
Interval 15796.85 to 28390.54
|
20937.42 Arbitrary Unit*1/dilution
Interval 15870.99 to 27621.2
|
29301.54 Arbitrary Unit*1/dilution
Interval 23585.66 to 36402.65
|
17064.67 Arbitrary Unit*1/dilution
Interval 11672.26 to 24948.29
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=42 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1
Day 273
|
17076.66 Arbitrary Unit*1/dilution
Interval 10473.04 to 27844.1
|
32534.84 Arbitrary Unit*1/dilution
Interval 26919.75 to 39321.16
|
23893.33 Arbitrary Unit*1/dilution
Interval 18564.9 to 30751.12
|
32425.08 Arbitrary Unit*1/dilution
Interval 21983.11 to 47826.98
|
16703.38 Arbitrary Unit*1/dilution
Interval 11834.44 to 23575.51
|
28966.27 Arbitrary Unit*1/dilution
Interval 23528.68 to 35660.51
|
17723.13 Arbitrary Unit*1/dilution
Interval 12813.36 to 24514.19
|
31957.12 Arbitrary Unit*1/dilution
Interval 26552.95 to 38461.16
|
24213.35 Arbitrary Unit*1/dilution
Interval 16852.99 to 34788.27
|
—
|
—
|
—
|
24178.96 Arbitrary Unit*1/dilution
Interval 18403.28 to 31767.28
|
14704.04 Arbitrary Unit*1/dilution
Interval 10028.46 to 21559.51
|
23258.35 Arbitrary Unit*1/dilution
Interval 18060.99 to 29951.32
|
27851.85 Arbitrary Unit*1/dilution
Interval 22434.81 to 34576.86
|
26576.68 Arbitrary Unit*1/dilution
Interval 18819.49 to 37531.31
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1
Day 366
|
18956.68 Arbitrary Unit*1/dilution
Interval 12843.92 to 27978.66
|
33290.21 Arbitrary Unit*1/dilution
Interval 27256.77 to 40659.19
|
27094.44 Arbitrary Unit*1/dilution
Interval 21748.26 to 33754.83
|
38608.31 Arbitrary Unit*1/dilution
Interval 27513.93 to 54176.26
|
28150.35 Arbitrary Unit*1/dilution
Interval 21687.99 to 36538.3
|
36376.96 Arbitrary Unit*1/dilution
Interval 30108.13 to 43951.04
|
22608.60 Arbitrary Unit*1/dilution
Interval 17315.37 to 29519.94
|
35405.05 Arbitrary Unit*1/dilution
Interval 29961.85 to 41837.12
|
30940.18 Arbitrary Unit*1/dilution
Interval 20898.62 to 45806.59
|
11447.53 Arbitrary Unit*1/dilution
Interval 7975.7 to 16430.64
|
21327.55 Arbitrary Unit*1/dilution
Interval 15785.84 to 28814.7
|
24372.65 Arbitrary Unit*1/dilution
Interval 18560.59 to 32004.71
|
30280.41 Arbitrary Unit*1/dilution
Interval 24086.36 to 38067.32
|
26161.22 Arbitrary Unit*1/dilution
Interval 19977.7 to 34258.68
|
26060.07 Arbitrary Unit*1/dilution
Interval 20334.56 to 33397.68
|
35118.48 Arbitrary Unit*1/dilution
Interval 28980.53 to 42556.43
|
21955.78 Arbitrary Unit*1/dilution
Interval 15487.15 to 31126.19
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1
Day 1, Pre-Dose
|
1422.80 Arbitrary Unit*1/dilution
Interval 1017.63 to 1989.31
|
10772.57 Arbitrary Unit*1/dilution
Interval 8973.74 to 12931.97
|
6603.35 Arbitrary Unit*1/dilution
Interval 5520.89 to 7898.04
|
11890.69 Arbitrary Unit*1/dilution
Interval 6800.37 to 20791.3
|
1730.28 Arbitrary Unit*1/dilution
Interval 1227.75 to 2438.52
|
6229.00 Arbitrary Unit*1/dilution
Interval 4948.44 to 7840.96
|
1107.26 Arbitrary Unit*1/dilution
Interval 824.3 to 1487.36
|
7371.42 Arbitrary Unit*1/dilution
Interval 5895.73 to 9216.47
|
10063.53 Arbitrary Unit*1/dilution
Interval 6193.38 to 16352.09
|
1396.82 Arbitrary Unit*1/dilution
Interval 1093.87 to 1783.67
|
14461.60 Arbitrary Unit*1/dilution
Interval 12217.34 to 17118.11
|
7615.66 Arbitrary Unit*1/dilution
Interval 6046.08 to 9592.7
|
6473.05 Arbitrary Unit*1/dilution
Interval 5240.33 to 7995.76
|
1894.19 Arbitrary Unit*1/dilution
Interval 1415.79 to 2534.24
|
12682.79 Arbitrary Unit*1/dilution
Interval 11027.18 to 14586.97
|
4897.12 Arbitrary Unit*1/dilution
Interval 3961.65 to 6053.5
|
2690.71 Arbitrary Unit*1/dilution
Interval 1617.54 to 4475.89
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1
Day 15
|
—
|
—
|
—
|
41302.86 Arbitrary Unit*1/dilution
Interval 35166.31 to 48510.25
|
—
|
—
|
—
|
—
|
35909.49 Arbitrary Unit*1/dilution
Interval 30979.84 to 41623.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17186.74 Arbitrary Unit*1/dilution
Interval 11268.72 to 26212.74
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1
Day 29
|
6193.90 Arbitrary Unit*1/dilution
Interval 4991.47 to 7685.99
|
35454.71 Arbitrary Unit*1/dilution
Interval 32016.76 to 39261.82
|
34878.85 Arbitrary Unit*1/dilution
Interval 30128.13 to 40378.68
|
37407.78 Arbitrary Unit*1/dilution
Interval 31604.6 to 44276.52
|
36782.02 Arbitrary Unit*1/dilution
Interval 32597.13 to 41504.18
|
48350.60 Arbitrary Unit*1/dilution
Interval 46008.19 to 50812.27
|
33526.55 Arbitrary Unit*1/dilution
Interval 30717.21 to 36592.83
|
45935.88 Arbitrary Unit*1/dilution
Interval 42533.31 to 49610.66
|
34856.19 Arbitrary Unit*1/dilution
Interval 29860.57 to 40687.57
|
32520.96 Arbitrary Unit*1/dilution
Interval 29393.0 to 35981.79
|
42841.53 Arbitrary Unit*1/dilution
Interval 40641.1 to 45161.11
|
40054.71 Arbitrary Unit*1/dilution
Interval 36657.11 to 43767.22
|
27283.88 Arbitrary Unit*1/dilution
Interval 23749.99 to 31343.58
|
31272.17 Arbitrary Unit*1/dilution
Interval 28043.87 to 34872.11
|
43721.86 Arbitrary Unit*1/dilution
Interval 41391.13 to 46183.83
|
45352.29 Arbitrary Unit*1/dilution
Interval 42292.27 to 48633.72
|
14825.07 Arbitrary Unit*1/dilution
Interval 9202.62 to 23882.64
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1
Day 91
|
4208.70 Arbitrary Unit*1/dilution
Interval 3415.97 to 5185.39
|
33090.44 Arbitrary Unit*1/dilution
Interval 29307.61 to 37361.54
|
26048.76 Arbitrary Unit*1/dilution
Interval 23040.07 to 29450.34
|
32383.00 Arbitrary Unit*1/dilution
Interval 25355.82 to 41357.72
|
23195.15 Arbitrary Unit*1/dilution
Interval 19169.97 to 28065.51
|
36714.60 Arbitrary Unit*1/dilution
Interval 33409.99 to 40346.06
|
19848.42 Arbitrary Unit*1/dilution
Interval 17098.69 to 23040.36
|
37238.30 Arbitrary Unit*1/dilution
Interval 33422.26 to 41490.05
|
29771.28 Arbitrary Unit*1/dilution
Interval 22790.3 to 38890.64
|
19450.29 Arbitrary Unit*1/dilution
Interval 16870.47 to 22424.61
|
31822.66 Arbitrary Unit*1/dilution
Interval 29344.28 to 34510.36
|
29761.16 Arbitrary Unit*1/dilution
Interval 26479.16 to 33449.97
|
24769.12 Arbitrary Unit*1/dilution
Interval 21201.21 to 28937.48
|
18843.89 Arbitrary Unit*1/dilution
Interval 16118.82 to 22029.67
|
33605.00 Arbitrary Unit*1/dilution
Interval 30904.7 to 36541.24
|
36641.95 Arbitrary Unit*1/dilution
Interval 32888.47 to 40823.81
|
9451.28 Arbitrary Unit*1/dilution
Interval 5664.54 to 15769.45
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1
Day 181
|
8068.78 Arbitrary Unit*1/dilution
Interval 5382.52 to 12095.67
|
31914.57 Arbitrary Unit*1/dilution
Interval 26757.61 to 38065.43
|
18216.90 Arbitrary Unit*1/dilution
Interval 14922.99 to 22237.85
|
28431.40 Arbitrary Unit*1/dilution
Interval 18586.62 to 43490.66
|
19131.14 Arbitrary Unit*1/dilution
Interval 14925.42 to 24521.95
|
25309.68 Arbitrary Unit*1/dilution
Interval 21792.52 to 29394.49
|
13553.35 Arbitrary Unit*1/dilution
Interval 10925.88 to 16812.68
|
29076.21 Arbitrary Unit*1/dilution
Interval 24647.52 to 34300.65
|
23753.89 Arbitrary Unit*1/dilution
Interval 16497.38 to 34202.24
|
10642.97 Arbitrary Unit*1/dilution
Interval 8866.09 to 12775.95
|
19755.04 Arbitrary Unit*1/dilution
Interval 17184.1 to 22710.63
|
19310.73 Arbitrary Unit*1/dilution
Interval 16064.57 to 23212.85
|
23385.30 Arbitrary Unit*1/dilution
Interval 19247.69 to 28412.35
|
12437.92 Arbitrary Unit*1/dilution
Interval 9712.65 to 15927.87
|
24536.98 Arbitrary Unit*1/dilution
Interval 21093.54 to 28542.55
|
30020.08 Arbitrary Unit*1/dilution
Interval 25781.35 to 34955.7
|
14585.46 Arbitrary Unit*1/dilution
Interval 8187.65 to 25982.52
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=42 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1
Day 366
|
6123.72 Arbitrary Unit*1/dilution
Interval 3670.11 to 10217.67
|
14026.72 Arbitrary Unit*1/dilution
Interval 9872.16 to 19929.68
|
11526.24 Arbitrary Unit*1/dilution
Interval 8306.97 to 15993.08
|
17215.73 Arbitrary Unit*1/dilution
Interval 9109.88 to 32534.08
|
11695.26 Arbitrary Unit*1/dilution
Interval 7877.62 to 17362.99
|
18446.49 Arbitrary Unit*1/dilution
Interval 13727.47 to 24787.74
|
8475.77 Arbitrary Unit*1/dilution
Interval 5826.3 to 12330.07
|
17580.65 Arbitrary Unit*1/dilution
Interval 13597.51 to 22730.58
|
13220.17 Arbitrary Unit*1/dilution
Interval 7525.15 to 23225.18
|
3412.16 Arbitrary Unit*1/dilution
Interval 2132.56 to 5459.55
|
9039.16 Arbitrary Unit*1/dilution
Interval 5869.21 to 13921.2
|
10520.02 Arbitrary Unit*1/dilution
Interval 7172.27 to 15430.37
|
11973.35 Arbitrary Unit*1/dilution
Interval 8408.1 to 17050.36
|
9769.74 Arbitrary Unit*1/dilution
Interval 6826.15 to 13982.68
|
11132.59 Arbitrary Unit*1/dilution
Interval 7711.59 to 16071.22
|
16727.74 Arbitrary Unit*1/dilution
Interval 12527.94 to 22335.47
|
7339.99 Arbitrary Unit*1/dilution
Interval 4511.75 to 11941.14
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1
Day 1, Pre-Dose
|
350.87 Arbitrary Unit*1/dilution
Interval 246.1 to 500.26
|
3749.08 Arbitrary Unit*1/dilution
Interval 3022.42 to 4650.45
|
1860.42 Arbitrary Unit*1/dilution
Interval 1479.73 to 2339.06
|
3595.20 Arbitrary Unit*1/dilution
Interval 1703.38 to 7588.14
|
484.90 Arbitrary Unit*1/dilution
Interval 332.63 to 706.87
|
2128.28 Arbitrary Unit*1/dilution
Interval 1648.9 to 2747.05
|
309.27 Arbitrary Unit*1/dilution
Interval 227.73 to 420.0
|
2525.90 Arbitrary Unit*1/dilution
Interval 1936.94 to 3293.94
|
3106.78 Arbitrary Unit*1/dilution
Interval 1690.15 to 5710.79
|
355.20 Arbitrary Unit*1/dilution
Interval 274.7 to 459.29
|
6123.52 Arbitrary Unit*1/dilution
Interval 4971.22 to 7542.92
|
2749.80 Arbitrary Unit*1/dilution
Interval 2052.91 to 3683.26
|
2052.63 Arbitrary Unit*1/dilution
Interval 1587.68 to 2653.76
|
502.26 Arbitrary Unit*1/dilution
Interval 368.31 to 684.92
|
4295.75 Arbitrary Unit*1/dilution
Interval 3567.51 to 5172.65
|
1579.63 Arbitrary Unit*1/dilution
Interval 1248.19 to 1999.08
|
504.21 Arbitrary Unit*1/dilution
Interval 254.26 to 999.86
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1
Day 15
|
—
|
—
|
—
|
21524.83 Arbitrary Unit*1/dilution
Interval 15803.89 to 29316.72
|
—
|
—
|
—
|
—
|
16656.77 Arbitrary Unit*1/dilution
Interval 13114.36 to 21156.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5968.57 Arbitrary Unit*1/dilution
Interval 3459.42 to 10297.64
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1
Day 29
|
1965.71 Arbitrary Unit*1/dilution
Interval 1516.28 to 2548.36
|
19054.68 Arbitrary Unit*1/dilution
Interval 16009.67 to 22678.84
|
21838.60 Arbitrary Unit*1/dilution
Interval 18092.58 to 26360.23
|
17202.81 Arbitrary Unit*1/dilution
Interval 11290.7 to 26210.67
|
22297.06 Arbitrary Unit*1/dilution
Interval 18563.04 to 26782.19
|
36401.71 Arbitrary Unit*1/dilution
Interval 33873.87 to 39118.19
|
18673.13 Arbitrary Unit*1/dilution
Interval 15994.05 to 21800.98
|
34724.95 Arbitrary Unit*1/dilution
Interval 31347.16 to 38466.71
|
15484.34 Arbitrary Unit*1/dilution
Interval 15484.34 to 20031.4
|
17068.46 Arbitrary Unit*1/dilution
Interval 14682.35 to 19842.35
|
31782.30 Arbitrary Unit*1/dilution
Interval 29363.05 to 34400.87
|
27187.51 Arbitrary Unit*1/dilution
Interval 23743.45 to 31131.14
|
12658.68 Arbitrary Unit*1/dilution
Interval 10282.31 to 15584.27
|
16188.16 Arbitrary Unit*1/dilution
Interval 13702.59 to 19124.61
|
30886.55 Arbitrary Unit*1/dilution
Interval 28161.7 to 33875.05
|
33890.21 Arbitrary Unit*1/dilution
Interval 30923.97 to 37140.98
|
5164.32 Arbitrary Unit*1/dilution
Interval 2788.59 to 9564.03
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1
Day 91
|
1183.72 Arbitrary Unit*1/dilution
Interval 927.65 to 1510.47
|
15698.38 Arbitrary Unit*1/dilution
Interval 12689.8 to 19420.25
|
13491.41 Arbitrary Unit*1/dilution
Interval 11242.96 to 16189.54
|
14911.93 Arbitrary Unit*1/dilution
Interval 8938.59 to 24877.04
|
9632.54 Arbitrary Unit*1/dilution
Interval 7467.24 to 12425.73
|
20953.73 Arbitrary Unit*1/dilution
Interval 17953.39 to 24455.47
|
7344.94 Arbitrary Unit*1/dilution
Interval 5884.1 to 9168.47
|
22018.09 Arbitrary Unit*1/dilution
Interval 18732.94 to 25879.35
|
13089.37 Arbitrary Unit*1/dilution
Interval 8831.07 to 19401.0
|
7269.52 Arbitrary Unit*1/dilution
Interval 5957.93 to 8869.84
|
18723.69 Arbitrary Unit*1/dilution
Interval 16542.78 to 21192.11
|
15312.25 Arbitrary Unit*1/dilution
Interval 12688.86 to 18478.02
|
9858.05 Arbitrary Unit*1/dilution
Interval 7826.42 to 12417.08
|
7249.59 Arbitrary Unit*1/dilution
Interval 5904.49 to 8901.12
|
19202.73 Arbitrary Unit*1/dilution
Interval 16618.1 to 22189.36
|
19275.37 Arbitrary Unit*1/dilution
Interval 16140.45 to 23019.18
|
3184.43 Arbitrary Unit*1/dilution
Interval 1790.03 to 5665.04
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1
Day 181
|
2515.63 Arbitrary Unit*1/dilution
Interval 1489.5 to 4248.65
|
12819.14 Arbitrary Unit*1/dilution
Interval 9426.83 to 17432.19
|
8133.44 Arbitrary Unit*1/dilution
Interval 6106.18 to 10833.76
|
11849.54 Arbitrary Unit*1/dilution
Interval 5860.75 to 23957.97
|
6689.46 Arbitrary Unit*1/dilution
Interval 4485.04 to 9977.37
|
10433.04 Arbitrary Unit*1/dilution
Interval 8403.37 to 12952.93
|
3979.56 Arbitrary Unit*1/dilution
Interval 2902.82 to 5455.69
|
12926.21 Arbitrary Unit*1/dilution
Interval 9991.57 to 16722.79
|
9530.78 Arbitrary Unit*1/dilution
Interval 5852.57 to 15520.67
|
2707.32 Arbitrary Unit*1/dilution
Interval 2155.08 to 3401.08
|
7586.78 Arbitrary Unit*1/dilution
Interval 6185.95 to 9304.83
|
6807.45 Arbitrary Unit*1/dilution
Interval 4485.04 to 9977.37
|
7831.52 Arbitrary Unit*1/dilution
Interval 5710.23 to 10740.85
|
4250.72 Arbitrary Unit*1/dilution
Interval 3036.25 to 5950.96
|
11306.69 Arbitrary Unit*1/dilution
Interval 8855.84 to 14435.81
|
12677.50 Arbitrary Unit*1/dilution
Interval 9988.16 to 16090.96
|
4536.90 Arbitrary Unit*1/dilution
Interval 2151.82 to 9565.6
|
—
|
|
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1
Day 273
|
5675.43 Arbitrary Unit*1/dilution
Interval 3026.13 to 10644.13
|
13092.16 Arbitrary Unit*1/dilution
Interval 9063.89 to 18910.71
|
10021.44 Arbitrary Unit*1/dilution
Interval 6943.97 to 14462.81
|
13423.41 Arbitrary Unit*1/dilution
Interval 6703.27 to 26880.61
|
6073.64 Arbitrary Unit*1/dilution
Interval 3512.87 to 10501.12
|
13184.85 Arbitrary Unit*1/dilution
Interval 9542.74 to 18217.03
|
5942.40 Arbitrary Unit*1/dilution
Interval 3751.38 to 9413.09
|
16035.47 Arbitrary Unit*1/dilution
Interval 11998.42 to 21430.86
|
9291.17 Arbitrary Unit*1/dilution
Interval 5629.0 to 15335.9
|
—
|
—
|
—
|
8225.58 Arbitrary Unit*1/dilution
Interval 5320.59 to 12716.67
|
4637.99 Arbitrary Unit*1/dilution
Interval 2773.84 to 7754.96
|
9622.02 Arbitrary Unit*1/dilution
Interval 6647.04 to 13928.49
|
12045.70 Arbitrary Unit*1/dilution
Interval 8784.62 to 16517.39
|
9499.76 Arbitrary Unit*1/dilution
Interval 5580.83 to 16170.6
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Geometric Mean AUC of Antibody Against WA-1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=30 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2
Day 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
921655.60 Arbitrary Unit*1/dilution
Interval 684452.31 to 1241063.88
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2
Day 1, Pre-Booster Vaccination 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
193349.76 Arbitrary Unit*1/dilution
Interval 136074.53 to 274732.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1201152.28 Arbitrary Unit*1/dilution
Interval 899527.72 to 1603915.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2
Day 91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
688925.53 Arbitrary Unit*1/dilution
Interval 520392.79 to 912038.74
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2
Day 181
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
445271.64 Arbitrary Unit*1/dilution
Interval 344427.79 to 575641.23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Geometric Mean AUC of Antibody Against BA.1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=30 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2
Day 1, Pre-Booster Vaccination 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
44367.39 Arbitrary Unit*1/dilution
Interval 30868.36 to 63769.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
365421.15 Arbitrary Unit*1/dilution
Interval 265045.53 to 503810.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2
Day 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
260668.10 Arbitrary Unit*1/dilution
Interval 185214.52 to 366860.32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2
Day 91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
178509.53 Arbitrary Unit*1/dilution
Interval 129548.91 to 245973.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2
Day 181
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
92349.30 Arbitrary Unit*1/dilution
Interval 69580.26 to 122569.16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Geometric Mean AUC of Antibody Against BA.5 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=30 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2
Day 1, Pre-Booster Vaccination 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
48314.42 Arbitrary Unit*1/dilution
Interval 33707.06 to 69252.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
409932.34 Arbitrary Unit*1/dilution
Interval 305116.01 to 550756.16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2
Day 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
297241.68 Arbitrary Unit*1/dilution
Interval 219857.75 to 401862.64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2
4Day 91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
215637.56 Arbitrary Unit*1/dilution
Interval 159513.03 to 291509.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2
Day 181
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
128920.81 Arbitrary Unit*1/dilution
Interval 98994.66 to 167893.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Geometric Mean of Pseudovirus Neutralization against D614G
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=42 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1
Day 273
|
848.73 titer
Interval 400.52 to 1798.52
|
2107.40 titer
Interval 1357.76 to 3270.92
|
992.82 titer
Interval 619.53 to 1591.02
|
2340.64 titer
Interval 938.86 to 5835.36
|
560.75 titer
Interval 290.22 to 1083.43
|
1079.67 titer
Interval 643.56 to 1811.29
|
805.15 titer
Interval 460.85 to 1406.67
|
1475.96 titer
Interval 936.75 to 2325.56
|
1364.44 titer
Interval 686.24 to 2712.92
|
—
|
—
|
—
|
1419.20 titer
Interval 822.04 to 2450.16
|
572.36 titer
Interval 292.96 to 1118.21
|
778.99 titer
Interval 475.29 to 1276.74
|
1056.44 titer
Interval 651.91 to 1712.0
|
1070.13 titer
Interval 615.88 to 1859.42
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1
Day 366
|
807.32 titer
Interval 436.19 to 1494.22
|
2645.09 titer
Interval 1690.99 to 4137.5
|
1358.34 titer
Interval 840.78 to 2194.47
|
2726.20 titer
Interval 1299.43 to 5719.59
|
1413.18 titer
Interval 847.65 to 2356.02
|
2068.00 titer
Interval 1235.25 to 3462.14
|
1337.80 titer
Interval 819.28 to 2184.51
|
2597.40 titer
Interval 1541.6 to 4376.28
|
1532.80 titer
Interval 777.13 to 3023.24
|
407.99 titer
Interval 234.4 to 710.13
|
800.31 titer
Interval 446.29 to 1435.16
|
1006.53 titer
Interval 597.0 to 1696.98
|
1982.45 titer
Interval 1267.8 to 3099.95
|
1480.60 titer
Interval 910.31 to 2408.18
|
1341.31 titer
Interval 772.63 to 2328.56
|
2612.67 titer
Interval 1608.56 to 4243.59
|
650.45 titer
Interval 392.51 to 1077.89
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1
Day 1, Pre-Dose
|
31.27 titer
Interval 20.13 to 48.57
|
254.91 titer
Interval 185.86 to 349.62
|
88.50 titer
Interval 63.17 to 123.98
|
373.44 titer
Interval 140.25 to 994.37
|
26.82 titer
Interval 16.92 to 42.51
|
66.26 titer
Interval 46.75 to 93.91
|
21.79 titer
Interval 15.82 to 30.0
|
120.75 titer
Interval 85.97 to 169.59
|
342.29 titer
Interval 129.7 to 903.34
|
38.68 titer
Interval 26.71 to 56.03
|
378.03 titer
Interval 288.46 to 495.41
|
102.44 titer
Interval 74.23 to 141.38
|
76.63 titer
Interval 55.25 to 106.28
|
39.01 titer
Interval 26.62 to 57.17
|
238.04 titer
Interval 186.1 to 304.48
|
55.58 titer
Interval 42.23 to 73.14
|
73.77 titer
Interval 39.67 to 137.16
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1
Day 15
|
129.85 titer
Interval 92.05 to 183.17
|
1578.80 titer
Interval 1200.37 to 2076.54
|
1806.48 titer
Interval 1379.39 to 2365.81
|
2431.34 titer
Interval 1407.84 to 4198.95
|
2232.85 titer
Interval 1694.7 to 2941.87
|
3799.17 titer
Interval 2939.29 to 4910.61
|
1804.29 titer
Interval 1444.29 to 2254.03
|
2944.85 titer
Interval 2332.78 to 3717.52
|
2839.93 titer
Interval 1786.26 to 4515.13
|
2816.89 titer
Interval 2166.33 to 3662.82
|
3758.62 titer
Interval 3043.39 to 4641.93
|
3246.95 titer
Interval 2464.58 to 4277.67
|
894.14 titer
Interval 652.14 to 1225.94
|
1419.60 titer
Interval 1006.82 to 2001.62
|
2865.92 titer
Interval 2388.29 to 3439.06
|
2778.25 titer
Interval 2159.32 to 3574.58
|
619.78 titer
Interval 342.68 to 1120.97
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1
Day 29
|
122.76 titer
Interval 92.01 to 163.79
|
2176.45 titer
Interval 1593.18 to 2973.27
|
1305.46 titer
Interval 1044.34 to 1631.89
|
1978.27 titer
Interval 1024.75 to 3819.03
|
1686.01 titer
Interval 1271.78 to 2235.15
|
3214.54 titer
Interval 2575.58 to 4012.01
|
1787.22 titer
Interval 1443.66 to 2212.53
|
3383.04 titer
Interval 2673.28 to 4281.24
|
2681.75 titer
Interval 1762.56 to 4080.31
|
1877.30 titer
Interval 1464.9 to 2405.79
|
2996.19 titer
Interval 2424.66 to 3702.44
|
2138.09 titer
Interval 1624.06 to 2814.81
|
1090.53 titer
Interval 807.37 to 1472.99
|
1001.61 titer
Interval 784.55 to 1278.72
|
2162.02 titer
Interval 1830.94 to 2552.96
|
3524.38 titer
Interval 2821.83 to 4401.83
|
499.25 titer
Interval 269.68 to 924.25
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1
Day 91
|
120.26 titer
Interval 90.65 to 159.55
|
2659.82 titer
Interval 1943.01 to 3641.09
|
845.35 titer
Interval 672.51 to 1062.61
|
1661.39 titer
Interval 776.81 to 3553.24
|
689.58 titer
Interval 509.41 to 933.49
|
1308.36 titer
Interval 1002.16 to 1708.11
|
538.84 titer
Interval 417.63 to 695.23
|
1390.28 titer
Interval 1046.31 to 1847.33
|
1741.71 titer
Interval 949.23 to 3195.82
|
816.75 titer
Interval 629.79 to 1059.2
|
1428.84 titer
Interval 1112.25 to 1835.55
|
1142.14 titer
Interval 827.88 to 1575.7
|
1459.31 titer
Interval 1058.33 to 2012.21
|
598.28 titer
Interval 460.06 to 778.03
|
1179.14 titer
Interval 961.53 to 1446.0
|
1208.81 titer
Interval 945.86 to 1544.84
|
305.52 titer
Interval 149.47 to 624.5
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1
Day 181
|
219.40 titer
Interval 124.87 to 385.51
|
1774.79 titer
Interval 1175.9 to 2678.7
|
476.94 titer
Interval 328.36 to 692.74
|
1557.44 titer
Interval 512.62 to 4731.84
|
683.16 titer
Interval 426.84 to 1093.41
|
658.36 titer
Interval 475.86 to 910.84
|
396.82 titer
Interval 281.85 to 558.69
|
962.58 titer
Interval 649.84 to 1425.81
|
1356.53 titer
Interval 660.14 to 2787.53
|
345.65 titer
Interval 256.06 to 466.6
|
599.64 titer
Interval 429.67 to 836.86
|
505.67 titer
Interval 348.87 to 732.94
|
999.79 titer
Interval 674.16 to 1482.71
|
293.20 titer
Interval 202.2 to 425.14
|
600.34 titer
Interval 450.64 to 799.77
|
1008.89 titer
Interval 707.85 to 1437.94
|
509.25 titer
Interval 208.17 to 1245.8
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. A subset of participants was analyzed for Group 1E-9E and 12E-14E.
Geometric Mean of Pseudovirus Neutralization against B.1.351
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=20 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=42 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=26 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=20 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=20 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1
Day 1, Pre-Dose
|
6.75 titer
Interval 4.0 to 11.39
|
28.82 titer
Interval 17.22 to 48.23
|
19.67 titer
Interval 12.53 to 30.86
|
77.29 titer
Interval 25.45 to 234.72
|
8.92 titer
Interval 6.43 to 12.38
|
15.07 titer
Interval 11.29 to 20.11
|
7.76 titer
Interval 5.1 to 11.8
|
41.70 titer
Interval 25.11 to 69.25
|
84.59 titer
Interval 31.88 to 224.5
|
8.66 titer
Interval 5.5 to 13.63
|
29.74 titer
Interval 17.8 to 49.69
|
17.81 titer
Interval 13.14 to 24.15
|
12.06 titer
Interval 7.39 to 19.68
|
7.99 titer
Interval 5.51 to 11.57
|
34.42 titer
Interval 21.87 to 54.17
|
21.38 titer
Interval 14.17 to 32.24
|
15.60 titer
Interval 8.41 to 28.93
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1
Day 29
|
17.61 titer
Interval 10.3 to 30.11
|
394.18 titer
Interval 196.49 to 790.76
|
219.26 titer
Interval 128.7 to 346.61
|
568.68 titer
Interval 291.85 to 1108.11
|
430.23 titer
Interval 305.22 to 606.45
|
899.83 titer
Interval 662.23 to 1222.66
|
275.33 titer
Interval 184.55 to 410.75
|
451.56 titer
Interval 280.55 to 759.36
|
1040.55 titer
Interval 631.42 to 1714.78
|
281.66 titer
Interval 188.71 to 420.39
|
439.79 titer
Interval 283.81 to 681.5
|
405.60 titer
Interval 233.58 to 704.32
|
155.05 titer
Interval 92.99 to 258.54
|
132.44 titer
Interval 103.98 to 168.69
|
398.86 titer
Interval 291.72 to 545.35
|
600.49 titer
Interval 343.98 to 1048.27
|
112.57 titer
Interval 52.02 to 243.59
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1
Day 273
|
—
|
—
|
—
|
—
|
269.32 titer
Interval 104.3 to 694.56
|
513.05 titer
Interval 265.67 to 990.79
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1
Day 366
|
—
|
—
|
—
|
—
|
490.51 titer
Interval 267.24 to 900.32
|
856.84 titer
Interval 499.99 to 1631.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1
Day 15
|
24.90 titer
Interval 13.06 to 47.45
|
449.28 titer
Interval 212.8 to 948.58
|
487.02 titer
Interval 340.72 to 696.13
|
—
|
362.95 titer
Interval 261.01 to 504.71
|
512.13 titer
Interval 362.77 to 722.99
|
673.88 titer
Interval 415.15 to 1093.86
|
1927.07 titer
Interval 1245.56 to 2981.45
|
—
|
407.53 titer
Interval 276.66 to 600.31
|
572.08 titer
Interval 358.19 to 913.69
|
582.60 titer
Interval 336.76 to 1007.9
|
233.11 titer
Interval 130.88 to 415.19
|
332.24 titer
Interval 241.41 to 457.23
|
607.55 titer
Interval 451.31 to 817.89
|
1464.22 titer
Interval 870.6 to 2462.6
|
—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1
Day 91
|
13.52 titer
Interval 7.87 to 23.21
|
548.74 titer
Interval 255.67 to 1177.78
|
184.88 titer
Interval 125.71 to 271.92
|
291.20 titer
Interval 116.89 to 725.47
|
126.92 titer
Interval 91.14 to 176.75
|
343.66 titer
Interval 244.68 to 482.68
|
105.17 titer
Interval 70.33 to 157.26
|
413.72 titer
Interval 223.45 to 766.04
|
408.30 titer
Interval 204.6 to 814.82
|
117.60 titer
Interval 80.61 to 171.56
|
199.21 titer
Interval 106.69 to 371.97
|
186.12 titer
Interval 106.25 to 326.04
|
216.16 titer
Interval 120.84 to 386.66
|
125.92 titer
Interval 78.66 to 201.57
|
252.19 titer
Interval 166.33 to 382.38
|
223.86 titer
Interval 122.35 to 409.58
|
48.11 titer
Interval 21.96 to 105.44
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1
Day 181
|
54.85 titer
Interval 18.09 to 166.37
|
455.71 titer
Interval 249.68 to 831.76
|
273.59 titer
Interval 96.48 to 775.84
|
—
|
174.12 titer
Interval 95.47 to 317.58
|
197.54 titer
Interval 131.19 to 297.45
|
69.40 titer
Interval 34.57 to 139.31
|
327.32 titer
Interval 111.3 to 963.23
|
—
|
46.02 titer
Interval 31.44 to 67.37
|
130.18 titer
Interval 47.43 to 357.26
|
73.97 titer
Interval 40.31 to 125.74
|
260.07 titer
Interval 134.87 to 501.46
|
68.94 titer
Interval 35.66 to 133.27
|
120.76 titer
Interval 59.11 to 246.73
|
183.98 titer
Interval 81.95 to 413.02
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. A subset of participants was analyzed for Groups 1E-3E and 10E-11E at Day 29.
Geometric Mean of Pseudovirus Neutralization against B.1.617.2
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1
Day 29
|
—
|
—
|
—
|
—
|
383.22 titer
Interval 246.35 to 596.13
|
1025.81 titer
Interval 698.85 to 1505.75
|
307.44 titer
Interval 249.56 to 378.74
|
782.88 titer
Interval 580.34 to 1056.12
|
—
|
506.87 titer
Interval 313.85 to 818.59
|
735.02 titer
Interval 507.0 to 1065.6
|
657.82 titer
Interval 384.22 to 1126.28
|
—
|
—
|
—
|
781.46 titer
Interval 608.79 to 1003.11
|
—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1
Day 1, Pre-Dose
|
10.27 titer
Interval 6.89 to 15.31
|
107.24 titer
Interval 74.39 to 154.6
|
34.46 titer
Interval 24.32 to 48.84
|
—
|
15.00 titer
Interval 8.25 to 27.25
|
48.46 titer
Interval 30.51 to 76.96
|
10.76 titer
Interval 8.53 to 13.57
|
61.98 titer
Interval 41.44 to 92.72
|
—
|
12.02 titer
Interval 8.07 to 17.92
|
101.40 titer
Interval 75.48 to 136.24
|
29.57 titer
Interval 21.58 to 40.5
|
35.11 titer
Interval 24.73 to 49.83
|
12.63 titer
Interval 8.82 to 18.08
|
90.35 titer
Interval 64.23 to 127.09
|
23.83 titer
Interval 17.38 to 32.68
|
—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1
Day 15
|
42.93 titer
Interval 29.64 to 62.17
|
759.42 titer
Interval 565.83 to 1019.25
|
907.09 titer
Interval 676.98 to 1215.41
|
—
|
—
|
—
|
623.94 titer
Interval 483.45 to 805.25
|
1420.34 titer
Interval 1069.37 to 1886.49
|
—
|
580.05 titer
Interval 434.9 to 773.64
|
1102.70 titer
Interval 905.86 to 1342.31
|
989.48 titer
Interval 733.87 to 1334.14
|
417.81 titer
Interval 290.52 to 600.88
|
490.28 titer
Interval 365.43 to 657.78
|
1525.15 titer
Interval 1239.54 to 1876.57
|
1399.37 titer
Interval 1075.48 to 1820.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Geometric Mean of Pseudovirus Neutralization against B.1.1.529
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=42 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1
Day 1, Pre-Dose
|
7.18 titer
Interval 5.44 to 9.49
|
20.32 titer
Interval 15.82 to 26.09
|
15.03 titer
Interval 12.29 to 18.38
|
51.38 titer
Interval 15.34 to 172.1
|
9.20 titer
Interval 6.7 to 12.63
|
15.30 titer
Interval 11.21 to 20.88
|
6.14 titer
Interval 5.27 to 7.14
|
13.94 titer
Interval 10.1 to 19.26
|
84.06 titer
Interval 28.12 to 251.32
|
6.04 titer
Interval 5.34 to 6.82
|
28.96 titer
Interval 22.26 to 37.67
|
14.06 titer
Interval 10.5 to 18.82
|
14.14 titer
Interval 10.59 to 18.88
|
9.01 titer
Interval 6.71 to 12.09
|
23.02 titer
Interval 18.29 to 28.99
|
10.25 titer
Interval 8.14 to 12.93
|
12.67 titer
Interval 7.09 to 22.66
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1
Day 15
|
20.23 titer
Interval 9.32 to 43.92
|
—
|
493.38 titer
Interval 258.09 to 943.16
|
749.46 titer
Interval 323.18 to 1738.0
|
—
|
—
|
—
|
1039.56 titer
Interval 529.84 to 2039.65
|
816.04 titer
Interval 472.76 to 1408.58
|
—
|
705.75 titer
Interval 352.82 to 1411.71
|
—
|
229.00 titer
Interval 91.27 to 574.57
|
241.39 titer
Interval 123.57 to 471.55
|
—
|
—
|
126.81 titer
Interval 61.79 to 260.24
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1
Day 29
|
26.93 titer
Interval 19.5 to 37.18
|
459.30 titer
Interval 295.56 to 713.75
|
464.12 titer
Interval 341.34 to 631.07
|
704.28 titer
Interval 313.97 to 1579.8
|
395.65 titer
Interval 265.72 to 589.13
|
952.49 titer
Interval 670.44 to 1353.19
|
303.22 titer
Interval 222.61 to 413.02
|
586.83 titer
Interval 425.97 to 808.43
|
1181.12 titer
Interval 639.02 to 2183.1
|
240.50 titer
Interval 175.63 to 329.34
|
533.35 titer
Interval 403.74 to 704.57
|
648.16 titer
Interval 440.9 to 952.87
|
358.92 titer
Interval 249.95 to 515.39
|
238.77 titer
Interval 173.87 to 327.89
|
499.59 titer
Interval 371.65 to 671.57
|
1076.92 titer
Interval 784.89 to 1477.59
|
114.81 titer
Interval 51.74 to 254.75
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1
Day 91
|
11.15 titer
Interval 8.78 to 14.17
|
180.65 titer
Interval 115.7 to 282.07
|
131.04 titer
Interval 91.52 to 187.61
|
589.29 titer
Interval 248.62 to 1396.74
|
136.63 titer
Interval 91.99 to 202.91
|
368.11 titer
Interval 256.47 to 528.36
|
89.71 titer
Interval 62.51 to 128.74
|
247.05 titer
Interval 170.31 to 358.38
|
627.30 titer
Interval 307.69 to 1278.94
|
36.18 titer
Interval 26.34 to 49.68
|
100.71 titer
Interval 72.76 to 139.42
|
108.13 titer
Interval 72.31 to 161.69
|
123.04 titer
Interval 81.81 to 185.02
|
63.64 titer
Interval 46.13 to 87.81
|
183.12 titer
Interval 138.6 to 241.95
|
406.30 titer
Interval 286.71 to 575.77
|
82.90 titer
Interval 38.02 to 180.79
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1
Day 181
|
76.78 titer
Interval 40.61 to 145.14
|
499.15 titer
Interval 295.81 to 842.26
|
170.76 titer
Interval 100.43 to 290.34
|
360.07 titer
Interval 63.89 to 2029.2
|
217.99 titer
Interval 109.36 to 434.51
|
222.76 titer
Interval 136.84 to 362.65
|
66.61 titer
Interval 38.45 to 115.38
|
175.75 titer
Interval 97.08 to 318.14
|
753.27 titer
Interval 299.16 to 1896.69
|
31.78 titer
Interval 23.21 to 43.52
|
73.17 titer
Interval 49.15 to 108.95
|
72.58 titer
Interval 47.71 to 110.42
|
339.84 titer
Interval 194.48 to 593.83
|
80.65 titer
Interval 50.79 to 128.05
|
140.61 titer
Interval 87.05 to 227.13
|
307.56 titer
Interval 170.82 to 553.77
|
209.59 titer
Interval 69.7 to 630.27
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1
Day 273
|
223.89 titer
Interval 90.67 to 552.84
|
480.51 titer
Interval 240.17 to 961.35
|
324.05 titer
Interval 177.6 to 591.24
|
1221.74 titer
Interval 418.03 to 3570.65
|
150.67 titer
Interval 59.57 to 381.09
|
254.41 titer
Interval 121.74 to 531.66
|
258.14 titer
Interval 118.81 to 560.88
|
421.76 titer
Interval 215.93 to 823.79
|
1012.61 titer
Interval 456.88 to 2244.31
|
—
|
—
|
—
|
364.66 titer
Interval 181.21 to 733.83
|
157.27 titer
Interval 73.05 to 338.59
|
159.41 titer
Interval 86.09 to 295.18
|
333.17 titer
Interval 173.11 to 641.21
|
859.98 titer
Interval 386.11 to 1915.39
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1
Day 366
|
203.18 titer
Interval 98.77 to 417.96
|
483.16 titer
Interval 261.67 to 892.13
|
442.53 titer
Interval 242.01 to 809.19
|
1307.88 titer
Interval 652.45 to 2621.71
|
835.72 titer
Interval 433.04 to 1612.89
|
1048.01 titer
Interval 502.09 to 2187.54
|
518.33 titer
Interval 258.81 to 1038.08
|
725.75 titer
Interval 381.49 to 1380.67
|
1201.30 titer
Interval 545.41 to 2645.94
|
102.18 titer
Interval 53.54 to 194.99
|
232.18 titer
Interval 107.17 to 503.01
|
353.35 titer
Interval 183.42 to 680.7
|
566.71 titer
Interval 295.77 to 1085.87
|
575.70 titer
Interval 311.61 to 1063.6
|
239.69 titer
Interval 119.72 to 479.88
|
1052.87 titer
Interval 565.12 to 1961.59
|
648.36 titer
Interval 407.78 to 1030.88
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Geometric Mean of Pseudovirus Neutralization against D614G
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=30 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Day 1, Pre-Vaccination 1
|
—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
13.23 titer
Interval 6.82 to 25.67
|
—
|
—
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—
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—
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—
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—
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—
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—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Day 43, Post Vaccination 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4010.57 titer
Interval 2785.54 to 5774.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Day 15, Post Booster Vaccination 1
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
7456.62 titer
Interval 4647.0 to 11964.94
|
—
|
—
|
—
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—
|
—
|
—
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—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Day 1, Pre-Booster Vaccination 2
|
—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
2225.56 titer
Interval 1468.38 to 3373.2
|
—
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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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—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Day 15, Post-Booster Vaccination 2
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
18927.45 titer
Interval 13150.29 to 27242.6
|
—
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—
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—
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—
|
—
|
—
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—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Day 29, Post-Booster Vaccination 2
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
17481.83 titer
Interval 11657.5 to 26216.11
|
—
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—
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—
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—
|
—
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—
|
—
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—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Day 91, Post-Booster Vaccination 2
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
9244.35 titer
Interval 6596.46 to 12955.15
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
|
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Day 181, Post-Booster Vaccination 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3932.11 titer
Interval 2993.93 to 5164.27
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Geometric Mean of Pseudovirus Neutralization against BA.1
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=30 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
Day 1, Pre-Vaccination 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.36 titer
Interval 4.51 to 8.96
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
Day 43, Post Vaccination 1
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
189.09 titer
Interval 100.15 to 357.04
|
—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
Day 15, Post Booster Vaccination 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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—
|
2680.27 titer
Interval 1368.13 to 5250.85
|
—
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—
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—
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—
|
—
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—
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—
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—
|
|
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
Day 1, Pre-Booster Vaccination 2
|
—
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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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—
|
679.09 titer
Interval 376.79 to 1223.91
|
—
|
—
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—
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—
|
—
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—
|
—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
Day 15, Post-Booster Vaccination 2
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
12381.92 titer
Interval 7615.21 to 20132.34
|
—
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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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—
|
|
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
Day 29, Post-Booster Vaccination 2
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
9496.08 titer
Interval 5113.33 to 17635.4
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
Day 91, Post-Booster Vaccination 2
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
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—
|
3272.98 titer
Interval 2290.23 to 4677.44
|
—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
Day 181, Post-Booster Vaccination 2
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
4076.50 titer
Interval 2337.99 to 7107.76
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Geometric Mean of Pseudovirus Neutralization against BA.4/5
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=30 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
Day 1, Pre-Vaccination 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.59 titer
Interval 4.83 to 11.93
|
—
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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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|
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
Day 43, Post Vaccination 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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—
|
—
|
260.47 titer
Interval 141.07 to 480.92
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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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|
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
Day 15, Post Booster Vaccination 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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1377.38 titer
Interval 854.38 to 2220.54
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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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|
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
Day 1, Pre-Booster Vaccination 2
|
—
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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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—
|
464.55 titer
Interval 253.81 to 850.28
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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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|
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
Day 15, Post-Booster Vaccination 2
|
—
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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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10328.08 titer
Interval 6854.83 to 15561.19
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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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|
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
Day 29, Post-Booster Vaccination 2
|
—
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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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—
|
7558.08 titer
Interval 4947.1 to 11547.08
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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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|
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
Day 91, Post-Booster Vaccination 2
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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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—
|
6848.36 titer
Interval 4320.84 to 10854.38
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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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|
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
Day 181, Post-Booster Vaccination 2
|
—
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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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2540.36 titer
Interval 1707.64 to 3779.15
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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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PRIMARY outcome
Timeframe: Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Geometric Mean of Pseudovirus Neutralization against XBB.1
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=30 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
Day 1, Pre-Vaccination 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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5.28 titer
Interval 4.72 to 5.91
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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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|
Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
Day 43, Post Vaccination 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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24.37 titer
Interval 14.01 to 42.37
|
—
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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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|
Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
Day 15, Post Booster Vaccination 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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132.74 titer
Interval 75.92 to 232.1
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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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Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
Day 1, Pre-Booster Vaccination 2
|
—
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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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39.52 titer
Interval 24.28 to 64.33
|
—
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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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|
Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
Day 15, Post-Booster Vaccination 2
|
—
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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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969.29 titer
Interval 576.68 to 1629.2
|
—
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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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|
Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
Day 29, Post-Booster Vaccination 2
|
—
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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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—
|
648.84 titer
Interval 389.17 to 1081.76
|
—
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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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|
Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
Day 91, Post-Booster Vaccination 2
|
—
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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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—
|
462.50 titer
Interval 288.1 to 742.47
|
—
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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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|
Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
Day 181, Post-Booster Vaccination 2
|
—
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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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—
|
211.99 titer
Interval 135.32 to 332.1
|
—
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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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—
|
PRIMARY outcome
Timeframe: Day 1 through Day 29 for Cohort 1, 28 days post any vaccination in Cohort 2Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Number of participants who experienced any unsolicited AEs through 28 days post vaccination
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=16 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=43 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=47 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=31 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
n=106 Participants
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Any Unsolicited Adverse Events (AEs)
|
31 Participants
|
28 Participants
|
24 Participants
|
6 Participants
|
22 Participants
|
24 Participants
|
20 Participants
|
30 Participants
|
14 Participants
|
28 Participants
|
29 Participants
|
31 Participants
|
28 Participants
|
28 Participants
|
29 Participants
|
25 Participants
|
8 Participants
|
60 Participants
|
PRIMARY outcome
Timeframe: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Number of participants that experienced any AESIs during the course of the study. An adverse event of special interest (serious or nonserious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is required. AESIs include anosmia, ageusia, subacute thyroiditis, acute pancreatitis, appendicitis, rhabdomyolysis, acute respiratory distress syndrome, coagulation disorders, acute cardiovascular injury, acute kidney injury, acute liver injury, dermatologic findings, multisystem inflammatory disorders, thrombocytopenia, acute aseptic arthritis, new onset of or worsening of neurologic disease, anaphylaxis, and other syndromes.
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=16 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=43 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=47 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=31 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
n=106 Participants
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590Number of participants that experienced any NOCMCs during the course of the study
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=16 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=43 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=47 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=31 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
n=106 Participants
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Number of participants that experienced MAAEs during the course of the study.
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=16 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=43 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=47 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=31 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
n=106 Participants
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Medically-attended Adverse Events (MAAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a lifethreatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=16 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=43 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=47 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=31 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
n=106 Participants
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Any Serious Adverse Events (SAEs)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8 for Cohort 1, and through 7 days post any vaccination for Cohort 2Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Number of participants who experienced any systemic solicited AEs through 7 days post any vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever.
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=16 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=43 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=47 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=31 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
n=106 Participants
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)
|
39 Participants
|
42 Participants
|
46 Participants
|
10 Participants
|
37 Participants
|
38 Participants
|
41 Participants
|
42 Participants
|
23 Participants
|
38 Participants
|
47 Participants
|
45 Participants
|
42 Participants
|
39 Participants
|
38 Participants
|
40 Participants
|
17 Participants
|
93 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8 for Cohort 1, and through 7 days post any vaccination for Cohort 2Population: The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Number of participants who experienced any local solicited AEs through 7 days post any vaccination. Local events include: pain at injection site, erythema, and induration.
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=16 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=43 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=47 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=31 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
n=106 Participants
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Local Solicited Reactogenicity Adverse Events (AEs)
|
38 Participants
|
35 Participants
|
45 Participants
|
5 Participants
|
39 Participants
|
45 Participants
|
42 Participants
|
41 Participants
|
16 Participants
|
41 Participants
|
44 Participants
|
41 Participants
|
35 Participants
|
48 Participants
|
39 Participants
|
40 Participants
|
11 Participants
|
94 Participants
|
PRIMARY outcome
Timeframe: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=48 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=48 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=41 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1
Day 366
|
83 percentage of participants
Interval 65.0 to 94.0
|
18 percentage of participants
Interval 8.0 to 34.0
|
35 percentage of participants
Interval 21.0 to 51.0
|
50 percentage of participants
Interval 19.0 to 81.0
|
75 percentage of participants
Interval 57.0 to 89.0
|
52 percentage of participants
Interval 37.0 to 68.0
|
85 percentage of participants
Interval 69.0 to 94.0
|
44 percentage of participants
Interval 28.0 to 60.0
|
35 percentage of participants
Interval 15.0 to 59.0
|
56 percentage of participants
Interval 41.0 to 70.0
|
7 percentage of participants
Interval 1.0 to 18.0
|
26 percentage of participants
Interval 14.0 to 41.0
|
47 percentage of participants
Interval 32.0 to 62.0
|
78 percentage of participants
Interval 64.0 to 89.0
|
11 percentage of participants
Interval 4.0 to 25.0
|
70 percentage of participants
Interval 54.0 to 83.0
|
67 percentage of participants
Interval 41.0 to 87.0
|
—
|
|
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1
Day 15
|
—
|
—
|
—
|
47 percentage of participants
Interval 21.0 to 73.0
|
—
|
—
|
—
|
—
|
45 percentage of participants
Interval 26.0 to 64.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
58 percentage of participants
Interval 33.0 to 80.0
|
—
|
|
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1
Day 29
|
46 percentage of participants
Interval 31.0 to 61.0
|
15 percentage of participants
Interval 6.0 to 28.0
|
50 percentage of participants
Interval 36.0 to 64.0
|
43 percentage of participants
Interval 18.0 to 71.0
|
90 percentage of participants
Interval 77.0 to 97.0
|
68 percentage of participants
Interval 53.0 to 80.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
55 percentage of participants
Interval 40.0 to 69.0
|
45 percentage of participants
Interval 26.0 to 64.0
|
94 percentage of participants
Interval 84.0 to 99.0
|
12 percentage of participants
Interval 4.0 to 24.0
|
37 percentage of participants
Interval 23.0 to 52.0
|
45 percentage of participants
Interval 31.0 to 60.0
|
88 percentage of participants
Interval 77.0 to 96.0
|
14 percentage of participants
Interval 6.0 to 26.0
|
80 percentage of participants
Interval 65.0 to 90.0
|
44 percentage of participants
Interval 22.0 to 69.0
|
—
|
|
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1
Day 91
|
25 percentage of participants
Interval 14.0 to 40.0
|
15 percentage of participants
Interval 6.0 to 28.0
|
26 percentage of participants
Interval 14.0 to 40.0
|
38 percentage of participants
Interval 14.0 to 68.0
|
83 percentage of participants
Interval 67.0 to 93.0
|
46 percentage of participants
Interval 31.0 to 61.0
|
86 percentage of participants
Interval 71.0 to 95.0
|
48 percentage of participants
Interval 34.0 to 63.0
|
40 percentage of participants
Interval 21.0 to 61.0
|
88 percentage of participants
Interval 76.0 to 96.0
|
6 percentage of participants
Interval 1.0 to 17.0
|
26 percentage of participants
Interval 15.0 to 40.0
|
43 percentage of participants
Interval 31.0 to 60.0
|
78 percentage of participants
Interval 65.0 to 89.0
|
8 percentage of participants
Interval 2.0 to 19.0
|
59 percentage of participants
Interval 43.0 to 73.0
|
32 percentage of participants
Interval 13.0 to 57.0
|
—
|
|
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1
Day 181
|
50 percentage of participants
Interval 35.0 to 65.0
|
9 percentage of participants
Interval 2.0 to 21.0
|
22 percentage of participants
Interval 11.0 to 36.0
|
27 percentage of participants
Interval 6.0 to 61.0
|
60 percentage of participants
Interval 42.0 to 76.0
|
31 percentage of participants
Interval 18.0 to 45.0
|
82 percentage of participants
Interval 68.0 to 92.0
|
36 percentage of participants
Interval 22.0 to 52.0
|
26 percentage of participants
Interval 10.0 to 48.0
|
65 percentage of participants
Interval 51.0 to 78.0
|
2 percentage of participants
Interval 1.0 to 11.0
|
8 percentage of participants
Interval 2.0 to 20.0
|
40 percentage of participants
Interval 26.0 to 55.0
|
60 percentage of participants
Interval 44.0 to 74.0
|
6 percentage of participants
Interval 1.0 to 17.0
|
52 percentage of participants
Interval 37.0 to 67.0
|
47 percentage of participants
Interval 24.0 to 71.0
|
—
|
|
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1
Day 273
|
84 percentage of participants
Interval 64.0 to 95.0
|
14 percentage of participants
Interval 5.0 to 30.0
|
31 percentage of participants
Interval 17.0 to 48.0
|
36 percentage of participants
Interval 11.0 to 69.0
|
46 percentage of participants
Interval 28.0 to 66.0
|
34 percentage of participants
Interval 20.0 to 51.0
|
88 percentage of participants
Interval 72.0 to 97.0
|
50 percentage of participants
Interval 32.0 to 68.0
|
27 percentage of participants
Interval 11.0 to 50.0
|
—
|
—
|
—
|
38 percentage of participants
Interval 22.0 to 55.0
|
51 percentage of participants
Interval 34.0 to 68.0
|
10 percentage of participants
Interval 3.0 to 24.0
|
57 percentage of participants
Interval 39.0 to 73.0
|
61 percentage of participants
Interval 36.0 to 83.0
|
—
|
PRIMARY outcome
Timeframe: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=48 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=48 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=41 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1
Day 15
|
—
|
—
|
—
|
53 percentage of participants
Interval 27.0 to 79.0
|
—
|
—
|
—
|
—
|
55 percentage of participants
Interval 36.0 to 74.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
84 percentage of participants
Interval 60.0 to 97.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1
Day 29
|
56 percentage of participants
Interval 41.0 to 71.0
|
35 percentage of participants
Interval 22.0 to 51.0
|
72 percentage of participants
Interval 58.0 to 84.0
|
50 percentage of participants
Interval 23.0 to 77.0
|
98 percentage of participants
Interval 87.0 to 99.0
|
90 percentage of participants
Interval 78.0 to 97.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
78 percentage of participants
Interval 63.0 to 88.0
|
52 percentage of participants
Interval 33.0 to 71.0
|
98 percentage of participants
Interval 90.0 to 99.0
|
33 percentage of participants
Interval 21.0 to 48.0
|
76 percentage of participants
Interval 61.0 to 87.0
|
47 percentage of participants
Interval 33.0 to 62.0
|
96 percentage of participants
Interval 87.0 to 99.0
|
43 percentage of participants
Interval 29.0 to 58.0
|
87 percentage of participants
Interval 73.0 to 95.0
|
78 percentage of participants
Interval 52.0 to 94.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1
Day 91
|
35 percentage of participants
Interval 22.0 to 51.0
|
34 percentage of participants
Interval 21.0 to 49.0
|
38 percentage of participants
Interval 25.0 to 54.0
|
46 percentage of participants
Interval 19.0 to 75.0
|
95 percentage of participants
Interval 83.0 to 99.0
|
76 percentage of participants
Interval 65.0 to 90.0
|
98 percentage of participants
Interval 87.0 to 99.0
|
68 percentage of participants
Interval 53.0 to 80.0
|
48 percentage of participants
Interval 28.0 to 69.0
|
94 percentage of participants
Interval 84.0 to 99.0
|
16 percentage of participants
Interval 7.0 to 29.0
|
50 percentage of participants
Interval 36.0 to 94.0
|
43 percentage of participants
Interval 29.0 to 58.0
|
84 percentage of participants
Interval 71.0 to 93.0
|
25 percentage of participants
Interval 14.0 to 40.0
|
83 percentage of participants
Interval 69.0 to 92.0
|
42 percentage of participants
Interval 20.0 to 67.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1
Day 181
|
50 percentage of participants
Interval 35.0 to 65.0
|
44 percentage of participants
Interval 30.0 to 60.0
|
26 percentage of participants
Interval 14.0 to 41.0
|
36 percentage of participants
Interval 11.0 to 39.0
|
80 percentage of participants
Interval 63.0 to 92.0
|
51 percentage of participants
Interval 36.0 to 66.0
|
87 percentage of participants
Interval 73.0 to 95.0
|
43 percentage of participants
Interval 28.0 to 59.0
|
30 percentage of participants
Interval 13.0 to 53.0
|
75 percentage of participants
Interval 61.0 to 86.0
|
4 percentage of participants
Interval 1.0 to 14.0
|
16 percentage of participants
Interval 7.0 to 30.0
|
48 percentage of participants
Interval 34.0 to 63.0
|
74 percentage of participants
Interval 60.0 to 86.0
|
12 percentage of participants
Interval 5.0 to 24.0
|
63 percentage of participants
Interval 48.0 to 77.0
|
63 percentage of participants
Interval 38.0 to 84.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1
Day 273
|
80 percentage of participants
Interval 59.0 to 93.0
|
46 percentage of participants
Interval 29.0 to 63.0
|
46 percentage of participants
Interval 30.0 to 63.0
|
45 percentage of participants
Interval 17.0 to 77.0
|
68 percentage of participants
Interval 48.0 to 84.0
|
59 percentage of participants
Interval 42.0 to 74.0
|
94 percentage of participants
Interval 80.0 to 99.0
|
68 percentage of participants
Interval 49.0 to 83.0
|
36 percentage of participants
Interval 17.0 to 59.0
|
—
|
—
|
—
|
54 percentage of participants
Interval 37.0 to 71.0
|
65 percentage of participants
Interval 47.0 to 80.0
|
26 percentage of participants
Interval 13.0 to 42.0
|
68 percentage of participants
Interval 50.0 to 82.0
|
72 percentage of participants
Interval 47.0 to 90.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1
Day 366
|
87 percentage of participants
Interval 69.0 to 96.0
|
49 percentage of participants
Interval 32.0 to 65.0
|
60 percentage of participants
Interval 44.0 to 75.0
|
60 percentage of participants
Interval 26.0 to 88.0
|
94 percentage of participants
Interval 79.0 to 99.0
|
70 percentage of participants
Interval 55.0 to 83.0
|
92 percentage of participants
Interval 79.0 to 98.0
|
68 percentage of participants
Interval 52.0 to 82.0
|
50 percentage of participants
Interval 27.0 to 73.0
|
68 percentage of participants
Interval 53.0 to 80.0
|
20 percentage of participants
Interval 10.0 to 35.0
|
48 percentage of participants
Interval 33.0 to 63.0
|
53 percentage of participants
Interval 38.0 to 68.0
|
85 percentage of participants
Interval 71.0 to 94.0
|
25 percentage of participants
Interval 13.0 to 40.0
|
79 percentage of participants
Interval 64.0 to 90.0
|
78 percentage of participants
Interval 52.0 to 94.0
|
—
|
PRIMARY outcome
Timeframe: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.617.2 S2-P
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=48 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=48 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=41 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1
Day 15
|
—
|
—
|
—
|
53 percentage of participants
Interval 27.0 to 79.0
|
—
|
—
|
—
|
—
|
52 percentage of participants
Interval 33.0 to 71.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
68 percentage of participants
Interval 43.0 to 87.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1
Day 29
|
48 percentage of participants
Interval 33.0 to 63.0
|
27 percentage of participants
Interval 15.0 to 42.0
|
70 percentage of participants
Interval 55.0 to 82.0
|
50 percentage of participants
Interval 23.0 to 77.0
|
95 percentage of participants
Interval 83.0 to 99.0
|
88 percentage of participants
Interval 76.0 to 95.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
71 percentage of participants
Interval 57.0 to 83.0
|
48 percentage of participants
Interval 29.0 to 67.0
|
96 percentage of participants
Interval 87.0 to 99.0
|
27 percentage of participants
Interval 16.0 to 42.0
|
67 percentage of participants
Interval 52.0 to 80.0
|
51 percentage of participants
Interval 37.0 to 65.0
|
96 percentage of participants
Interval 87.0 to 99.0
|
39 percentage of participants
Interval 26.0 to 54.0
|
87 percentage of participants
Interval 73.0 to 95.0
|
61 percentage of participants
Interval 36.0 to 83.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1
Day 91
|
31 percentage of participants
Interval 19.0 to 46.0
|
26 percentage of participants
Interval 14.0 to 40.0
|
38 percentage of participants
Interval 25.0 to 54.0
|
46 percentage of participants
Interval 19.0 to 75.0
|
93 percentage of participants
Interval 80.0 to 98.0
|
77 percentage of participants
Interval 63.0 to 88.0
|
98 percentage of participants
Interval 87.0 to 99.0
|
66 percentage of participants
Interval 51.0 to 79.0
|
36 percentage of participants
Interval 18.0 to 57.0
|
90 percentage of participants
Interval 79.0 to 97.0
|
6 percentage of participants
Interval 1.0 to 17.0
|
40 percentage of participants
Interval 26.0 to 55.0
|
51 percentage of participants
Interval 37.0 to 65.0
|
86 percentage of participants
Interval 74.0 to 94.0
|
22 percentage of participants
Interval 11.0 to 35.0
|
74 percentage of participants
Interval 59.0 to 86.0
|
32 percentage of participants
Interval 13.0 to 57.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1
Day 181
|
50 percentage of participants
Interval 35.0 to 65.0
|
31 percentage of participants
Interval 18.0 to 47.0
|
28 percentage of participants
Interval 16.0 to 43.0
|
36 percentage of participants
Interval 11.0 to 69.0
|
83 percentage of participants
Interval 66.0 to 93.0
|
49 percentage of participants
Interval 34.0 to 64.0
|
91 percentage of participants
Interval 79.0 to 98.0
|
41 percentage of participants
Interval 26.0 to 57.0
|
30 percentage of participants
Interval 13.0 to 53.0
|
73 percentage of participants
Interval 59.0 to 84.0
|
2 percentage of participants
Interval 1.0 to 11.0
|
18 percentage of participants
Interval 9.0 to 32.0
|
50 percentage of participants
Interval 36.0 to 64.0
|
64 percentage of participants
Interval 49.0 to 77.0
|
12 percentage of participants
Interval 5.0 to 24.0
|
61 percentage of participants
Interval 45.0 to 75.0
|
58 percentage of participants
Interval 33.0 to 80.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1
Day 273
|
80 percentage of participants
Interval 59.0 to 93.0
|
37 percentage of participants
Interval 21.0 to 55.0
|
46 percentage of participants
Interval 30.0 to 63.0
|
45 percentage of participants
Interval 17.0 to 77.0
|
68 percentage of participants
Interval 48.0 to 84.0
|
56 percentage of participants
Interval 40.0 to 72.0
|
94 percentage of participants
Interval 80.0 to 99.0
|
65 percentage of participants
Interval 46.0 to 80.0
|
27 percentage of participants
Interval 11.0 to 50.0
|
—
|
—
|
—
|
51 percentage of participants
Interval 34.0 to 68.0
|
62 percentage of participants
Interval 45.0 to 78.0
|
23 percentage of participants
Interval 11.0 to 39.0
|
65 percentage of participants
Interval 47.0 to 80.0
|
72 percentage of participants
Interval 47.0 to 90.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1
Day 366
|
87 percentage of participants
Interval 69.0 to 96.0
|
38 percentage of participants
Interval 23.0 to 55.0
|
60 percentage of participants
Interval 44.0 to 75.0
|
60 percentage of participants
Interval 26.0 to 88.0
|
88 percentage of participants
Interval 71.0 to 96.0
|
70 percentage of participants
Interval 55.0 to 83.0
|
92 percentage of participants
Interval 79.0 to 98.0
|
66 percentage of participants
Interval 49.0 to 80.0
|
40 percentage of participants
Interval 19.0 to 64.0
|
68 percentage of participants
Interval 53.0 to 80.0
|
18 percentage of participants
Interval 8.0 to 32.0
|
46 percentage of participants
Interval 31.0 to 61.0
|
58 percentage of participants
Interval 42.0 to 72.0
|
85 percentage of participants
Interval 71.0 to 94.0
|
25 percentage of participants
Interval 13.0 to 40.0
|
77 percentage of participants
Interval 61.0 to 88.0
|
72 percentage of participants
Interval 47.0 to 90.0
|
—
|
PRIMARY outcome
Timeframe: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.1.529 S2-P
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=48 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=48 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=41 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1
Day 366
|
87 percentage of participants
Interval 66.0 to 96.0
|
62 percentage of participants
Interval 45.0 to 77.0
|
60 percentage of participants
Interval 44.0 to 75.0
|
60 percentage of participants
Interval 26.0 to 88.0
|
97 percentage of participants
Interval 84.0 to 99.0
|
70 percentage of participants
Interval 55.0 to 83.0
|
92 percentage of participants
Interval 79.0 to 98.0
|
73 percentage of participants
Interval 57.0 to 86.0
|
50 percentage of participants
Interval 27.0 to 73.0
|
66 percentage of participants
Interval 51.0 to 79.0
|
31 percentage of participants
Interval 18.0 to 47.0
|
54 percentage of participants
Interval 39.0 to 69.0
|
62 percentage of participants
Interval 49.0 to 76.0
|
85 percentage of participants
Interval 71.0 to 94.0
|
48 percentage of participants
Interval 32.0 to 63.0
|
81 percentage of participants
Interval 67.0 to 92.0
|
78 percentage of participants
Interval 52.0 to 94.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1
Day 15
|
—
|
—
|
—
|
60 percentage of participants
Interval 32.0 to 84.0
|
—
|
—
|
—
|
—
|
59 percentage of participants
Interval 39.0 to 76.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
84 percentage of participants
Interval 60.0 to 97.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1
Day 29
|
69 percentage of participants
Interval 54.0 to 81.0
|
63 percentage of participants
Interval 47.0 to 76.0
|
96 percentage of participants
Interval 86.0 to 99.0
|
50 percentage of participants
Interval 23.0 to 77.0
|
98 percentage of participants
Interval 87.0 to 99.0
|
96 percentage of participants
Interval 86.0 to 99.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
92 percentage of participants
Interval 80.0 to 98.0
|
52 percentage of participants
Interval 33.0 to 71.0
|
100 percentage of participants
Interval 93.0 to 100.0
|
63 percentage of participants
Interval 48.0 to 76.0
|
92 percentage of participants
Interval 80.0 to 98.0
|
57 percentage of participants
Interval 42.0 to 71.0
|
98 percentage of participants
Interval 90.0 to 99.0
|
78 percentage of participants
Interval 65.0 to 89.0
|
98 percentage of participants
Interval 88.0 to 99.0
|
86 percentage of participants
Interval 65.0 to 99.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1
Day 91
|
38 percentage of participants
Interval 24.0 to 53.0
|
53 percentage of participants
Interval 38.0 to 68.0
|
79 percentage of participants
Interval 64.0 to 89.0
|
46 percentage of participants
Interval 19.0 to 75.0
|
95 percentage of participants
Interval 83.0 to 99.0
|
85 percentage of participants
Interval 72.0 to 94.0
|
98 percentage of participants
Interval 87.0 to 99.0
|
78 percentage of participants
Interval 64.0 to 88.0
|
52 percentage of participants
Interval 31.0 to 72.0
|
90 percentage of participants
Interval 79.0 to 97.0
|
28 percentage of participants
Interval 16.0 to 42.0
|
68 percentage of participants
Interval 53.0 to 80.0
|
55 percentage of participants
Interval 40.0 to 69.0
|
94 percentage of participants
Interval 84.0 to 99.0
|
49 percentage of participants
Interval 35.0 to 63.0
|
91 percentage of participants
Interval 79.0 to 98.0
|
68 percentage of participants
Interval 43.0 to 87.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1
Day 181
|
50 percentage of participants
Interval 35.0 to 65.0
|
47 percentage of participants
Interval 32.0 to 62.0
|
52 percentage of participants
Interval 37.0 to 67.0
|
36 percentage of participants
Interval 11.0 to 69.0
|
77 percentage of participants
Interval 60.0 to 90.0
|
59 percentage of participants
Interval 44.0 to 73.0
|
82 percentage of participants
Interval 68.0 to 92.0
|
57 percentage of participants
Interval 41.0 to 72.0
|
30 percentage of participants
Interval 13.0 to 53.0
|
75 percentage of participants
Interval 61.0 to 86.0
|
6 percentage of participants
Interval 1.0 to 17.0
|
20 percentage of participants
Interval 10.0 to 34.0
|
48 percentage of participants
Interval 34.0 to 63.0
|
70 percentage of participants
Interval 55.0 to 83.0
|
28 percentage of participants
Interval 16.0 to 42.0
|
72 percentage of participants
Interval 57.0 to 84.0
|
63 percentage of participants
Interval 38.0 to 84.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1
Day 273
|
84 percentage of participants
Interval 64.0 to 95.0
|
63 percentage of participants
Interval 45.0 to 79.0
|
56 percentage of participants
Interval 40.0 to 72.0
|
45 percentage of participants
Interval 17.0 to 77.0
|
68 percentage of participants
Interval 48.0 to 84.0
|
66 percentage of participants
Interval 49.0 to 80.0
|
91 percentage of participants
Interval 76.0 to 98.0
|
68 percentage of participants
Interval 49.0 to 83.0
|
36 percentage of participants
Interval 17.0 to 59.0
|
—
|
—
|
—
|
54 percentage of participants
Interval 37.0 to 71.0
|
57 percentage of participants
Interval 39.0 to 73.0
|
38 percentage of participants
Interval 23.0 to 55.0
|
73 percentage of participants
Interval 56.0 to 86.0
|
78 percentage of participants
Interval 52.0 to 94.0
|
—
|
PRIMARY outcome
Timeframe: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
61 percentage of participants
Interval 41.0 to 78.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2
Day 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
56 percentage of participants
Interval 35.0 to 75.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2
Day 91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
41 percentage of participants
Interval 24.0 to 61.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2
Day 181
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
26 percentage of participants
Interval 11.0 to 46.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against BA.1 S2-P
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
79 percentage of participants
Interval 59.0 to 92.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2
Day 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
70 percentage of participants
Interval 50.0 to 86.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2
Day 91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
38 percentage of participants
Interval 21.0 to 58.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2
Day 181
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
19 percentage of participants
Interval 6.0 to 38.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against BA.5 S2-P
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
79 percentage of participants
Interval 59.0 to 92.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2
Day 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
70 percentage of participants
Interval 50.0 to 86.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2
Day 91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
45 percentage of participants
Interval 26.0 to 64.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2
Day 181
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
37 percentage of participants
Interval 19.0 to 58.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=41 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 1
Day 273
|
72 percentage of participants
Interval 51.0 to 88.0
|
63 percentage of participants
Interval 45.0 to 79.0
|
64 percentage of participants
Interval 47.0 to 79.0
|
45 percentage of participants
Interval 17.0 to 77.0
|
75 percentage of participants
Interval 55.0 to 89.0
|
73 percentage of participants
Interval 57.0 to 86.0
|
94 percentage of participants
Interval 80.0 to 99.0
|
76 percentage of participants
Interval 59.0 to 89.0
|
41 percentage of participants
Interval 21.0 to 64.0
|
—
|
—
|
—
|
73 percentage of participants
Interval 56.0 to 86.0
|
62 percentage of participants
Interval 45.0 to 78.0
|
51 percentage of participants
Interval 35.0 to 68.0
|
83 percentage of participants
Interval 67.0 to 94.0
|
78 percentage of participants
Interval 52.0 to 94.0
|
—
|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 1
Day 15
|
50 percentage of participants
Interval 36.0 to 64.0
|
61 percentage of participants
Interval 46.0 to 75.0
|
98 percentage of participants
Interval 89.0 to 99.0
|
67 percentage of participants
Interval 38.0 to 88.0
|
98 percentage of participants
Interval 87.0 to 99.0
|
100 percentage of participants
Interval 93.0 to 100.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
98 percentage of participants
Interval 89.0 to 99.0
|
55 percentage of participants
Interval 36.0 to 74.0
|
100 percentage of participants
Interval 93.0 to 100.0
|
84 percentage of participants
Interval 71.0 to 93.0
|
100 percentage of participants
Interval 93.0 to 100.0
|
82 percentage of participants
Interval 69.0 to 91.0
|
98 percentage of participants
Interval 90.0 to 99.0
|
94 percentage of participants
Interval 84.0 to 99.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
63 percentage of participants
Interval 43.0 to 87.0
|
—
|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 1
Day 29
|
54 percentage of participants
Interval 39.0 to 69.0
|
73 percentage of participants
Interval 59.0 to 85.0
|
90 percentage of participants
Interval 78.0 to 97.0
|
50 percentage of participants
Interval 23.0 to 77.0
|
98 percentage of participants
Interval 87.0 to 99.0
|
98 percentage of participants
Interval 89.0 to 99.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
98 percentage of participants
Interval 89.0 to 99.0
|
55 percentage of participants
Interval 36.0 to 74.0
|
94 percentage of participants
Interval 84.0 to 99.0
|
80 percentage of participants
Interval 67.0 to 90.0
|
100 percentage of participants
Interval 93.0 to 100.0
|
80 percentage of participants
Interval 67.0 to 90.0
|
94 percentage of participants
Interval 84.0 to 99.0
|
90 percentage of participants
Interval 79.0 to 97.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
72 percentage of participants
Interval 47.0 to 90.0
|
—
|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 1
Day 91
|
44 percentage of participants
Interval 29.0 to 59.0
|
74 percentage of participants
Interval 60.0 to 86.0
|
72 percentage of participants
Interval 57.0 to 84.0
|
46 percentage of participants
Interval 19.0 to 75.0
|
95 percentage of participants
Interval 83.0 to 99.0
|
90 percentage of participants
Interval 77.0 to 97.0
|
95 percentage of participants
Interval 84.0 to 99.0
|
84 percentage of participants
Interval 71.0 to 93.0
|
52 percentage of participants
Interval 31.0 to 72.0
|
90 percentage of participants
Interval 79.0 to 97.0
|
42 percentage of participants
Interval 28.0 to 57.0
|
86 percentage of participants
Interval 73.0 to 94.0
|
88 percentage of participants
Interval 76.0 to 96.0
|
84 percentage of participants
Interval 71.0 to 93.0
|
57 percentage of participants
Interval 42.0 to 71.0
|
98 percentage of participants
Interval 88.0 to 99.0
|
53 percentage of participants
Interval 29.0 to 76.0
|
—
|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 1
Day 181
|
57 percentage of participants
Interval 41.0 to 72.0
|
64 percentage of participants
Interval 49.0 to 78.0
|
57 percentage of participants
Interval 41.0 to 71.0
|
36 percentage of participants
Interval 11.0 to 69.0
|
83 percentage of participants
Interval 66.0 to 93.0
|
78 percentage of participants
Interval 63.0 to 88.0
|
91 percentage of participants
Interval 79.0 to 98.0
|
66 percentage of participants
Interval 50.0 to 80.0
|
52 percentage of participants
Interval 31.0 to 73.0
|
73 percentage of participants
Interval 59.0 to 84.0
|
14 percentage of participants
Interval 6.0 to 27.0
|
49 percentage of participants
Interval 34.0 to 64.0
|
78 percentage of participants
Interval 64.0 to 88.0
|
62 percentage of participants
Interval 46.0 to 75.0
|
28 percentage of participants
Interval 16.0 to 42.0
|
87 percentage of participants
Interval 74.0 to 95.0
|
58 percentage of participants
Interval 33.0 to 80.0
|
—
|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 1
Day 366
|
80 percentage of participants
Interval 61.0 to 92.0
|
69 percentage of participants
Interval 52.0 to 83.0
|
77 percentage of participants
Interval 61.0 to 88.0
|
60 percentage of participants
Interval 26.0 to 88.0
|
88 percentage of participants
Interval 71.0 to 96.0
|
84 percentage of participants
Interval 70.0 to 93.0
|
95 percentage of participants
Interval 83.0 to 99.0
|
85 percentage of participants
Interval 71.0 to 94.0
|
50 percentage of participants
Interval 27.0 to 73.0
|
57 percentage of participants
Interval 42.0 to 71.0
|
38 percentage of participants
Interval 24.0 to 53.0
|
57 percentage of participants
Interval 41.0 to 71.0
|
83 percentage of participants
Interval 69.0 to 92.0
|
85 percentage of participants
Interval 71.0 to 94.0
|
61 percentage of participants
Interval 45.0 to 76.0
|
93 percentage of participants
Interval 81.0 to 99.0
|
72 percentage of participants
Interval 47.0 to 90.0
|
—
|
PRIMARY outcome
Timeframe: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. A subset of participants was analyzed for Group 1E-9E and 12E-14E.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=20 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=14 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=41 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=20 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=20 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=20 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1
Day 29
|
40 percentage of participants
Interval 19.0 to 64.0
|
80 percentage of participants
Interval 56.0 to 94.0
|
95 percentage of participants
Interval 75.0 to 99.0
|
64 percentage of participants
Interval 35.0 to 87.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 93.0 to 100.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
85 percentage of participants
Interval 62.0 to 97.0
|
59 percentage of participants
Interval 39.0 to 76.0
|
94 percentage of participants
Interval 73.0 to 99.0
|
95 percentage of participants
Interval 75.0 to 99.0
|
100 percentage of participants
Interval 82.0 to 100.0
|
95 percentage of participants
Interval 75.0 to 99.0
|
95 percentage of participants
Interval 75.0 to 99.0
|
85 percentage of participants
Interval 62.0 to 97.0
|
100 percentage of participants
Interval 82.0 to 100.0
|
61 percentage of participants
Interval 36.0 to 83.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1
Day 15
|
40 percentage of participants
Interval 19.0 to 64.0
|
90 percentage of participants
Interval 68.0 to 99.0
|
95 percentage of participants
Interval 75.0 to 99.0
|
—
|
98 percentage of participants
Interval 87.0 to 99.0
|
98 percentage of participants
Interval 89.0 to 99.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
—
|
95 percentage of participants
Interval 75.0 to 99.0
|
95 percentage of participants
Interval 75.0 to 99.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
95 percentage of participants
Interval 75.0 to 99.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1
Day 91
|
20 percentage of participants
Interval 6.0 to 44.0
|
80 percentage of participants
Interval 56.0 to 94.0
|
79 percentage of participants
Interval 54.0 to 94.0
|
46 percentage of participants
Interval 19.0 to 75.0
|
95 percentage of participants
Interval 83.0 to 99.0
|
94 percentage of participants
Interval 83.0 to 99.0
|
89 percentage of participants
Interval 67.0 to 99.0
|
80 percentage of participants
Interval 56.0 to 94.0
|
52 percentage of participants
Interval 31.0 to 72.0
|
85 percentage of participants
Interval 62.0 to 97.0
|
80 percentage of participants
Interval 56.0 to 94.0
|
95 percentage of participants
Interval 75.0 to 99.0
|
95 percentage of participants
Interval 75.0 to 99.0
|
90 percentage of participants
Interval 68.0 to 99.0
|
70 percentage of participants
Interval 46.0 to 88.0
|
80 percentage of participants
Interval 56.0 to 94.0
|
47 percentage of participants
Interval 24.0 to 71.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1
Day 181
|
56 percentage of participants
Interval 31.0 to 78.0
|
79 percentage of participants
Interval 54.0 to 94.0
|
69 percentage of participants
Interval 41.0 to 89.0
|
—
|
77 percentage of participants
Interval 60.0 to 90.0
|
82 percentage of participants
Interval 68.0 to 91.0
|
75 percentage of participants
Interval 51.0 to 91.0
|
59 percentage of participants
Interval 33.0 to 82.0
|
—
|
65 percentage of participants
Interval 41.0 to 85.0
|
32 percentage of participants
Interval 13.0 to 57.0
|
53 percentage of participants
Interval 29.0 to 76.0
|
90 percentage of participants
Interval 68.0 to 99.0
|
65 percentage of participants
Interval 41.0 to 85.0
|
35 percentage of participants
Interval 15.0 to 59.0
|
65 percentage of participants
Interval 41.0 to 85.0
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1
Day 273
|
—
|
—
|
—
|
—
|
79 percentage of participants
Interval 59.0 to 92.0
|
83 percentage of participants
Interval 68.0 to 93.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1
Day 366
|
—
|
—
|
—
|
—
|
91 percentage of participants
Interval 75.0 to 98.0
|
93 percentage of participants
Interval 81.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15, Day 29Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. This assay was not completed for Group 15E, 16E, and 17E.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.617.2
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=49 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=20 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=45 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=48 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=44 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1
Day 15
|
56 percentage of participants
Interval 41.0 to 70.0
|
65 percentage of participants
Interval 50.0 to 78.0
|
94 percentage of participants
Interval 83.0 to 99.0
|
—
|
—
|
—
|
100 percentage of participants
Interval 92.0 to 100.0
|
92 percentage of participants
Interval 80.0 to 98.0
|
—
|
94 percentage of participants
Interval 84.0 to 99.0
|
86 percentage of participants
Interval 74.0 to 94.0
|
100 percentage of participants
Interval 93.0 to 100.0
|
74 percentage of participants
Interval 60.0 to 85.0
|
96 percentage of participants
Interval 87.0 to 99.0
|
88 percentage of participants
Interval 76.0 to 96.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1
Day 29
|
—
|
—
|
—
|
—
|
90 percentage of participants
Interval 68.0 to 99.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
98 percentage of participants
Interval 88.0 to 99.0
|
83 percentage of participants
Interval 69.0 to 92.0
|
—
|
90 percentage of participants
Interval 68.0 to 99.0
|
70 percentage of participants
Interval 46.0 to 88.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
—
|
—
|
—
|
100 percentage of participants
Interval 91.0 to 100.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15, Day 29, Day 91, Day 181, Day 273, Day 366Population: The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.1.529
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=48 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=48 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=15 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=41 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 Participants
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=19 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1
Day 15
|
40 percentage of participants
Interval 12.0 to 74.0
|
—
|
100 percentage of participants
Interval 48.0 to 100.0
|
87 percentage of participants
Interval 60.0 to 98.0
|
—
|
—
|
—
|
94 percentage of participants
Interval 73.0 to 99.0
|
55 percentage of participants
Interval 36.0 to 74.0
|
—
|
90 percentage of participants
Interval 55.0 to 99.0
|
—
|
100 percentage of participants
Interval 69.0 to 100.0
|
100 percentage of participants
Interval 69.0 to 100.0
|
—
|
—
|
79 percentage of participants
Interval 54.0 to 94.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1
Day 29
|
52 percentage of participants
Interval 37.0 to 67.0
|
92 percentage of participants
Interval 80.0 to 98.0
|
98 percentage of participants
Interval 89.0 to 99.0
|
86 percentage of participants
Interval 57.0 to 98.0
|
95 percentage of participants
Interval 83.0 to 99.0
|
98 percentage of participants
Interval 89.0 to 99.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
98 percentage of participants
Interval 89.0 to 99.0
|
66 percentage of participants
Interval 46.0 to 82.0
|
100 percentage of participants
Interval 93.0 to 100.0
|
92 percentage of participants
Interval 81.0 to 98.0
|
98 percentage of participants
Interval 89.0 to 99.0
|
98 percentage of participants
Interval 90.0 to 99.0
|
92 percentage of participants
Interval 81.0 to 98.0
|
94 percentage of participants
Interval 84.0 to 99.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
83 percentage of participants
Interval 59.0 to 96.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1
Day 91
|
17 percentage of participants
Interval 7.0 to 30.0
|
68 percentage of participants
Interval 53.0 to 93.0
|
74 percentage of participants
Interval 60.0 to 86.0
|
69 percentage of participants
Interval 39.0 to 91.0
|
90 percentage of participants
Interval 76.0 to 97.0
|
92 percentage of participants
Interval 80.0 to 98.0
|
93 percentage of participants
Interval 81.0 to 99.0
|
92 percentage of participants
Interval 81.0 to 98.0
|
56 percentage of participants
Interval 35.0 to 76.0
|
67 percentage of participants
Interval 52.0 to 79.0
|
46 percentage of participants
Interval 32.0 to 61.0
|
72 percentage of participants
Interval 58.0 to 84.0
|
76 percentage of participants
Interval 63.0 to 87.0
|
76 percentage of participants
Interval 63.0 to 87.0
|
80 percentage of participants
Interval 67.0 to 90.0
|
96 percentage of participants
Interval 85.0 to 99.0
|
74 percentage of participants
Interval 49.0 to 91.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1
Day 181
|
61 percentage of participants
Interval 45.0 to 76.0
|
82 percentage of participants
Interval 68.0 to 92.0
|
74 percentage of participants
Interval 59.0 to 86.0
|
55 percentage of participants
Interval 23.0 to 83.0
|
83 percentage of participants
Interval 66.0 to 93.0
|
78 percentage of participants
Interval 63.0 to 88.0
|
67 percentage of participants
Interval 51.0 to 80.0
|
66 percentage of participants
Interval 50.0 to 80.0
|
57 percentage of participants
Interval 34.0 to 77.0
|
56 percentage of participants
Interval 41.0 to 70.0
|
31 percentage of participants
Interval 18.0 to 45.0
|
59 percentage of participants
Interval 44.0 to 73.0
|
88 percentage of participants
Interval 76.0 to 95.0
|
68 percentage of participants
Interval 53.0 to 81.0
|
52 percentage of participants
Interval 37.0 to 66.0
|
93 percentage of participants
Interval 82.0 to 99.0
|
68 percentage of participants
Interval 43.0 to 87.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1
Day 273
|
76 percentage of participants
Interval 55.0 to 91.0
|
83 percentage of participants
Interval 66.0 to 93.0
|
82 percentage of participants
Interval 66.0 to 92.0
|
82 percentage of participants
Interval 48.0 to 98.0
|
61 percentage of participants
Interval 41.0 to 78.0
|
66 percentage of participants
Interval 49.0 to 80.0
|
85 percentage of participants
Interval 68.0 to 95.0
|
85 percentage of participants
Interval 69.0 to 95.0
|
64 percentage of participants
Interval 41.0 to 83.0
|
—
|
—
|
—
|
70 percentage of participants
Interval 53.0 to 84.0
|
62 percentage of participants
Interval 45.0 to 78.0
|
51 percentage of participants
Interval 35.0 to 68.0
|
89 percentage of participants
Interval 74.0 to 97.0
|
94 percentage of participants
Interval 73.0 to 99.0
|
—
|
|
Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1
Day 366
|
80 percentage of participants
Interval 61.0 to 92.0
|
77 percentage of participants
Interval 61.0 to 89.0
|
79 percentage of participants
Interval 64.0 to 90.0
|
70 percentage of participants
Interval 35.0 to 93.0
|
97 percentage of participants
Interval 84.0 to 99.0
|
89 percentage of participants
Interval 75.0 to 96.0
|
85 percentage of participants
Interval 69.0 to 94.0
|
88 percentage of participants
Interval 74.0 to 96.0
|
55 percentage of participants
Interval 32.0 to 77.0
|
65 percentage of participants
Interval 50.0 to 78.0
|
51 percentage of participants
Interval 36.0 to 66.0
|
78 percentage of participants
Interval 64.0 to 89.0
|
83 percentage of participants
Interval 69.0 to 92.0
|
89 percentage of participants
Interval 76.0 to 96.0
|
66 percentage of participants
Interval 50.0 to 80.0
|
93 percentage of participants
Interval 81.0 to 99.0
|
89 percentage of participants
Interval 65.0 to 99.0
|
—
|
PRIMARY outcome
Timeframe: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against D614G
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=30 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Day 43 Post-Dose 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
97 percentage of participants
Interval 83.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Day 15 Post Booster Dose 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100 percentage of participants
Interval 88.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against BA.1
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=30 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Day 43 Post-Dose 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
97 percentage of participants
Interval 83.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Day 15 Post Booster Dose 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100 percentage of participants
Interval 88.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against BA.4/5
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=30 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Day 43 Post-Dose 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
97 percentage of participants
Interval 83.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Day 15 Post Booster Dose 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
87 percentage of participants
Interval 83.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 43 Post-Dose 1, Day 15 Post Booster Dose 1Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against XBB.1
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=30 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Day 43 Post-Dose 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
47 percentage of participants
Interval 28.0 to 66.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Day 15 Post Booster Dose 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
93 percentage of participants
Interval 78.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against D614G
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Day 15 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
71 percentage of participants
Interval 51.0 to 87.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Day 29 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
74 percentage of participants
Interval 54.0 to 89.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Day 91 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
45 percentage of participants
Interval 26.0 to 64.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Day 181 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
22 percentage of participants
Interval 9.0 to 42.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against BA.1
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Day 15 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
86 percentage of participants
Interval 67.0 to 96.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Day 29 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
89 percentage of participants
Interval 71.0 to 98.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Day 91 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
59 percentage of participants
Interval 39.0 to 76.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Day 181 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
59 percentage of participants
Interval 39.0 to 78.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against BA.4/5
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Day 15 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
89 percentage of participants
Interval 72.0 to 98.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Day 29 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
89 percentage of participants
Interval 71.0 to 98.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Day 91 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
90 percentage of participants
Interval 73.0 to 98.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Day 181 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
48 percentage of participants
Interval 29.0 to 68.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2Population: The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against XBB.1
Outcome measures
| Measure |
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=29 Participants
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Day 15 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
93 percentage of participants
Interval 76.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Day 29 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
93 percentage of participants
Interval 76.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Day 91 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
79 percentage of participants
Interval 69.0 to 92.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Day 181 Post-Booster Dose 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
48 percentage of participants
Interval 29.0 to 68.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Serious events: 4 serious events
Other events: 49 other events
Deaths: 1 deaths
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Cohort 2
Serious events: 5 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 participants at risk
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 participants at risk
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 participants at risk
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=43 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=47 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 participants at risk
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 participants at risk；n=56 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=20 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=16 participants at risk
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=31 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2
n=106 participants at risk
Prospective cohort with naïve to COVID-19 vaccine and infection participants \>/= 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval N=250
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
mRNA-1273.222: Formulated the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.2%
1/31 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Nervous system disorders
Seizure
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.2%
1/31 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Infections and infestations
Liver abscess
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
1.8%
1/56 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/49 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.94%
1/106 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Nervous system disorders
Intracranial mass
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/49 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/49 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.94%
1/106 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Infections and infestations
COVID-19
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.94%
1/106 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.94%
1/106 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.94%
1/106 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/56 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.94%
1/106 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
Other adverse events
| Measure |
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
n=53 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
n=51 participants at risk
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
n=50 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
|
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
n=50 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
n=49 participants at risk
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
n=51 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10\^10 vp (boost dose).
|
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
n=52 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
n=51 participants at risk
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
n=50 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
|
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
n=43 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
n=50 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
|
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
n=47 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
n=50 participants at risk
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
n=46 participants at risk；n=56 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
|
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
n=20 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10\^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
n=16 participants at risk
Previously (\>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
n=31 participants at risk
Previously (\>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
|
Cohort 2
n=106 participants at risk
Prospective cohort with naïve to COVID-19 vaccine and infection participants \>/= 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval N=250
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
mRNA-1273.222: Formulated the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
17.0%
9/53 • Number of events 9 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
19.6%
10/51 • Number of events 10 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
22.0%
11/50 • Number of events 11 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
18.0%
9/50 • Number of events 9 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
24.5%
12/49 • Number of events 12 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
17.6%
9/51 • Number of events 9 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
13.5%
7/52 • Number of events 7 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
15.7%
8/51 • Number of events 8 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
14.0%
7/50 • Number of events 7 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
16.3%
7/43 • Number of events 7 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
24.0%
12/50 • Number of events 12 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
14.9%
7/47 • Number of events 7 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
22.0%
11/50 • Number of events 11 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
13.0%
6/46 • Number of events 6 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
25.0%
5/20 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
25.0%
4/16 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.2%
1/31 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
40.6%
43/106 • Number of events 55 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
General disorders
Chills
|
20.8%
11/53 • Number of events 11 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
43.1%
22/51 • Number of events 22 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
46.0%
23/50 • Number of events 23 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
18.0%
9/50 • Number of events 9 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
46.9%
23/49 • Number of events 23 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
31.4%
16/51 • Number of events 16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
15.4%
8/52 • Number of events 8 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.9%
3/51 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
20.0%
10/50 • Number of events 10 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
27.9%
12/43 • Number of events 12 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
48.0%
24/50 • Number of events 24 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
12.8%
6/47 • Number of events 6 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
30.0%
15/50 • Number of events 15 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
43.5%
20/46 • Number of events 20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
10.0%
2/20 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
12.5%
2/16 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
12.9%
4/31 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
62.3%
66/106 • Number of events 98 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
General disorders
Injection site induration
|
15.1%
8/53 • Number of events 16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
17.6%
9/51 • Number of events 18 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
10.0%
5/50 • Number of events 10 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
7.8%
4/51 • Number of events 7 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.8%
3/52 • Number of events 6 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
13.7%
7/51 • Number of events 14 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.3%
1/43 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.0%
4/50 • Number of events 8 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.4%
3/47 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
10.9%
5/46 • Number of events 10 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.0%
1/20 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
17.9%
19/106 • Number of events 50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
General disorders
Injection site pain
|
77.4%
41/53 • Number of events 41 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
86.3%
44/51 • Number of events 44 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
82.0%
41/50 • Number of events 41 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
76.0%
38/50 • Number of events 38 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
71.4%
35/49 • Number of events 35 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
68.6%
35/51 • Number of events 35 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
92.3%
48/52 • Number of events 48 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
72.5%
37/51 • Number of events 37 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
90.0%
45/50 • Number of events 45 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
90.7%
39/43 • Number of events 39 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
90.0%
45/50 • Number of events 45 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
89.4%
42/47 • Number of events 42 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
82.0%
41/50 • Number of events 41 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
87.0%
40/46 • Number of events 40 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
55.0%
11/20 • Number of events 11 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
31.2%
5/16 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
48.4%
15/31 • Number of events 15 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
87.7%
93/106 • Number of events 220 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
General disorders
Malaise
|
66.0%
35/53 • Number of events 35 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
78.4%
40/51 • Number of events 40 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
74.0%
37/50 • Number of events 37 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
62.0%
31/50 • Number of events 31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
77.6%
38/49 • Number of events 38 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
74.5%
38/51 • Number of events 38 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
67.3%
35/52 • Number of events 35 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
66.7%
34/51 • Number of events 34 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
80.0%
40/50 • Number of events 40 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
79.1%
34/43 • Number of events 34 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
72.0%
36/50 • Number of events 36 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
66.0%
31/47 • Number of events 31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
72.0%
36/50 • Number of events 36 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
71.7%
33/46 • Number of events 33 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
65.0%
13/20 • Number of events 13 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
43.8%
7/16 • Number of events 7 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
41.9%
13/31 • Number of events 13 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
75.5%
80/106 • Number of events 172 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
General disorders
Pyrexia
|
9.4%
5/53 • Number of events 10 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
15.7%
8/51 • Number of events 16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
24.0%
12/50 • Number of events 24 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
30.6%
15/49 • Number of events 30 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
21.6%
11/51 • Number of events 22 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.8%
2/52 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.0%
4/50 • Number of events 8 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
9.3%
4/43 • Number of events 8 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
30.0%
15/50 • Number of events 30 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.1%
1/47 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
12.0%
6/50 • Number of events 12 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
19.6%
9/46 • Number of events 18 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
19.8%
21/106 • Number of events 52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.0%
1/20 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
35.8%
19/53 • Number of events 19 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
74.5%
38/51 • Number of events 38 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
70.0%
35/50 • Number of events 35 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
50.0%
25/50 • Number of events 25 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
65.3%
32/49 • Number of events 32 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
60.8%
31/51 • Number of events 31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
42.3%
22/52 • Number of events 22 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
43.1%
22/51 • Number of events 22 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
52.0%
26/50 • Number of events 26 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
62.8%
27/43 • Number of events 27 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
54.0%
27/50 • Number of events 27 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
53.2%
25/47 • Number of events 25 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
60.0%
30/50 • Number of events 30 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
63.0%
29/46 • Number of events 29 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
40.0%
8/20 • Number of events 8 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
25.0%
4/16 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
51.6%
16/31 • Number of events 16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
73.6%
78/106 • Number of events 145 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Nervous system disorders
Headache
|
30.2%
16/53 • Number of events 16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
64.7%
33/51 • Number of events 33 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
64.0%
32/50 • Number of events 32 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
50.0%
25/50 • Number of events 25 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
53.1%
26/49 • Number of events 26 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
45.1%
23/51 • Number of events 23 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
34.6%
18/52 • Number of events 18 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
54.9%
28/51 • Number of events 28 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
48.0%
24/50 • Number of events 24 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
41.9%
18/43 • Number of events 18 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
54.0%
27/50 • Number of events 27 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
42.6%
20/47 • Number of events 20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
42.0%
21/50 • Number of events 21 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
52.2%
24/46 • Number of events 24 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
50.0%
10/20 • Number of events 10 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
18.8%
3/16 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
19.4%
6/31 • Number of events 6 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
68.9%
73/106 • Number of events 123 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
General disorders
Injection site erythema
|
3.8%
2/53 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
11.8%
6/51 • Number of events 12 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.9%
3/51 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.8%
2/52 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.9%
2/51 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.3%
1/43 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
10.0%
5/50 • Number of events 10 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.3%
2/46 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.5%
2/31 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
11.3%
12/106 • Number of events 27 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.9%
3/51 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/49 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.8%
2/52 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.9%
2/51 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.0%
3/50 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.7%
2/43 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.0%
4/50 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.7%
4/46 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
10.0%
2/20 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
1.9%
2/106 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Cardiac disorders
Bradycardia
|
9.4%
5/53 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
7.8%
4/51 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.1%
2/49 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.9%
2/51 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.8%
2/52 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
7.8%
4/51 • Number of events 6 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.7%
2/43 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.0%
4/50 • Number of events 6 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.0%
4/50 • Number of events 6 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.3%
2/46 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
1.9%
2/106 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.8%
3/52 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Investigations
Blood pressure diastolic increased
|
5.7%
3/53 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.0%
4/50 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.2%
4/49 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
7.8%
4/51 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.8%
3/52 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
7.8%
4/51 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.0%
4/50 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.7%
2/43 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.3%
2/47 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
10.0%
5/50 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.3%
2/46 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
10.0%
2/20 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.2%
1/31 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.7%
6/106 • Number of events 6 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Investigations
Blood pressure increased
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/49 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.0%
3/50 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.2%
1/16 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.8%
4/106 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Investigations
Blood pressure systolic increased
|
5.7%
3/53 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
11.8%
6/51 • Number of events 6 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
10.0%
5/50 • Number of events 6 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.2%
4/49 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.9%
2/51 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
9.6%
5/52 • Number of events 7 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.9%
2/51 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.0%
4/50 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.3%
1/43 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.4%
3/47 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
10.0%
5/50 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.2%
1/46 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
15.0%
3/20 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.2%
1/31 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
14.2%
15/106 • Number of events 18 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Vascular disorders
Hypertension
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.0%
3/50 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/49 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.9%
3/51 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.3%
1/43 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
10.0%
5/50 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.5%
2/31 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Vascular disorders
Systolic hypertension
|
5.7%
3/53 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.9%
2/51 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.1%
3/49 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.9%
2/51 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.0%
3/50 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.5%
3/46 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.8%
3/106 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Congenital, familial and genetic disorders
Micrognathia
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.2%
1/16 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.0%
1/20 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.0%
1/20 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Infections and infestations
COVID-19
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/49 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.5%
2/31 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.8%
3/106 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.0%
3/50 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/49 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
7.0%
3/43 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.1%
1/47 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.0%
1/20 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.7%
5/106 • Number of events 6 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.3%
1/43 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.2%
1/16 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.94%
1/106 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Investigations
Heart rate decreased
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.0%
3/50 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.0%
3/50 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/49 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.0%
3/50 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.3%
2/47 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
8.0%
4/50 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.2%
1/16 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.8%
4/106 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.2%
1/16 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.2%
1/31 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Nervous system disorders
Dizziness
|
3.8%
2/53 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.0%
3/50 • Number of events 3 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.0%
3/50 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/49 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.9%
3/51 • Number of events 4 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.3%
1/43 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.0%
1/20 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
3.2%
1/31 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.94%
1/106 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.0%
1/20 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
1.9%
1/52 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.3%
1/43 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
5.0%
1/20 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
1.9%
2/106 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/53 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.0%
2/50 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/49 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/52 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
6.2%
1/16 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/106 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
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|
Investigations
Heart rate increased
|
1.9%
1/53 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
4.1%
2/49 • Number of events 2 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/51 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
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1.9%
1/52 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/51 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
2.0%
1/50 • Number of events 1 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/43 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/47 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/50 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/46 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/20 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/16 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
|
0.00%
0/31 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
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4.7%
5/106 • Number of events 5 • Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60