Trial Outcomes & Findings for Evaluation of Full Versus Fractional Dose of COVID-19 Vaccine Given as a Booster for the Prevention of COVID-19 in Adults in Mongolia. (NCT NCT05265065)

Results Overview

Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. The primary endpoint is the seroresponse rate at the Day-28 visit. The seroresponse rate at the individual level is defined as either a ≥4-fold rise in binding antibodies at the Day-28 visit compared to baseline (pre-vaccination) with a titre of \<200 BAU/ml, a ≥2-fold rise among participants with a baseline (pre-vaccination) titre of \>200 BAU/ml, or a ≥4-times the lower limit of detection if baseline levels are lower than the limit of detection.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

601 participants

Primary outcome timeframe

28-days post booster vaccination

Results posted on

2025-02-20

Participant Flow

There are two study arms (i.e. groups to which participants were randomised), as per "Arms and Interventions" in Protocol Section, corresponding to the primary analysis comparing a full dose to a fractional dose. Stratified randomisation was performed to ensure balanced randomisation according to the primary vaccine received (prior to this study) and age for secondary subgroup analyses. The Participant Flow was edited to reflect the randomisation of participants into two arms.

Participant milestones

Participant milestones
Measure	Standard 30µg Pfizer-BioNTech booster dose	Fractional 15µg Pfizer-BioNTech booster dose
Overall Study STARTED	300	301
Overall Study Received Allocated d Dose	299	299
Overall Study Included in Day 28 Immunogenicity Analysis	292	295
Overall Study COMPLETED	282	285
Overall Study NOT COMPLETED	18	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AstraZeneca (ChAdOx1-S, or Vaxzevria®) - Standard Pfizer-BioNTech Booster Group n=65 Participants Previously received two doses of AstraZeneca as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	AstraZeneca (ChAdOx1-S, or Vaxzevria®) - Fractional Pfizer-BioNTech Booster Group n=65 Participants Previously received two doses of AstraZeneca as primary COVID-19 vaccine . Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group n=201 Participants Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group n=200 Participants Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group n=34 Participants Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group n=36 Participants Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Total n=601 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=65 Participants	0 Participants n=65 Participants	3 Participants n=201 Participants	0 Participants n=200 Participants	0 Participants n=34 Participants	0 Participants n=36 Participants	3 Participants n=601 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=65 Participants	65 Participants n=65 Participants	189 Participants n=201 Participants	186 Participants n=200 Participants	30 Participants n=34 Participants	35 Participants n=36 Participants	570 Participants n=601 Participants
Age, Categorical >=65 years	0 Participants n=65 Participants	0 Participants n=65 Participants	9 Participants n=201 Participants	14 Participants n=200 Participants	4 Participants n=34 Participants	1 Participants n=36 Participants	28 Participants n=601 Participants
Age, Continuous	34.5 years n=65 Participants	40.2 years n=65 Participants	47.8 years n=201 Participants	48.8 years n=200 Participants	43.1 years n=34 Participants	41.3 years n=36 Participants	44 years n=601 Participants
Sex: Female, Male Female	33 Participants n=65 Participants	32 Participants n=65 Participants	115 Participants n=201 Participants	114 Participants n=200 Participants	19 Participants n=34 Participants	14 Participants n=36 Participants	327 Participants n=601 Participants
Sex: Female, Male Male	32 Participants n=65 Participants	33 Participants n=65 Participants	86 Participants n=201 Participants	86 Participants n=200 Participants	15 Participants n=34 Participants	22 Participants n=36 Participants	274 Participants n=601 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Mongolia	65 participants n=65 Participants	65 participants n=65 Participants	201 participants n=201 Participants	200 participants n=200 Participants	34 participants n=34 Participants	36 participants n=36 Participants	601 participants n=601 Participants
BMI	26.3 kg/m2 n=65 Participants	25.4 kg/m2 n=65 Participants	24.6 kg/m2 n=201 Participants	24.8 kg/m2 n=200 Participants	25.3 kg/m2 n=34 Participants	25.8 kg/m2 n=36 Participants	25.2 kg/m2 n=601 Participants

PRIMARY outcome

Timeframe: 28-days post booster vaccination

Population: The analysis of immunogenicity endpoints included all participants with outcome data. There are two study arms, as per "Arms and Interventions" in Protocol Section, corresponding to the primary analysis comparing a full dose to a fractional dose. Stratified randomisation was performed to ensure balanced randomisation according to the primary vaccine received (prior to this study) and age for secondary subgroup analyses. The primary outcome is unstratified.

Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. The primary endpoint is the seroresponse rate at the Day-28 visit. The seroresponse rate at the individual level is defined as either a ≥4-fold rise in binding antibodies at the Day-28 visit compared to baseline (pre-vaccination) with a titre of \<200 BAU/ml, a ≥2-fold rise among participants with a baseline (pre-vaccination) titre of \>200 BAU/ml, or a ≥4-times the lower limit of detection if baseline levels are lower than the limit of detection.

Outcome measures

Outcome measures
Measure	Standard n=292 Participants 30µg Pfizer-BioNTech booster dose	Fractional n=295 Participants 15µg Pfizer-BioNTech booster dose	Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
Seroresponse	253 Participants	250 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 7 days post booster vaccination

Population: The reactogenicity and safety analysis populations included all randomised participants who received a study vaccine, according to the vaccine received. There are two study arms, as per "Arms and Interventions" in Protocol Section. Stratified randomisation was performed to ensure balanced randomisation according to the primary vaccine received (prior to this study) and age for secondary subgroup analyses. The primary outcome is unstratified.

Questionnaire to document solicited reactions is developed specifically for this study. Data will be reported as the proportion of participants who report grade 3 or 4 reactions by each intervention arm. Solicited reactions such as pain, tenderness, erythema/redness, induration, swelling, fever, nausea, vomiting, headache, fatigue/malaise, myalgia, arthralgia, diarrhea, enlarged lymph nodes will be collected from the participants 7 days post-vaccination.

Outcome measures

Outcome measures
Measure	Standard n=299 Participants 30µg Pfizer-BioNTech booster dose	Fractional n=299 Participants 15µg Pfizer-BioNTech booster dose	Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
Solicited Grade 3 or 4 Local or Systemic Reaction	6 Participants	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 28-days post booster vaccination

Population: The analysis of immunogenicity endpoints included all participants with outcome data

Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. The primary endpoint is the seroresponse rate at the Day-28 visit. The seroresponse rate at the individual level is defined as either a ≥4-fold rise in binding antibodies at the Day-28 visit compared to baseline (pre-vaccination) with a titre of \<200 BAU/ml, a ≥2-fold rise among participants with a baseline (pre-vaccination) titre of \>200 BAU/ml, or a ≥4-times the lower limit of detection if baseline levels are lower than the limit of detection. Priming strata (previously COVID vaccination): AstraZeneca (ChAdOx1-S, or Vaxzevria®); Sinopharm (BBIBP-CorV®); Sputnik V (Gam-COVID-Vac®)

Outcome measures

Outcome measures
Measure	Standard n=65 Participants 30µg Pfizer-BioNTech booster dose	Fractional n=62 Participants 15µg Pfizer-BioNTech booster dose	Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group n=194 Participants Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group n=198 Participants Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group n=33 Participants Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group n=35 Participants Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
Seroresponse by Priming Vaccine Strata	55 Participants	52 Participants	170 Participants	169 Participants	28 Participants	29 Participants

SECONDARY outcome

Timeframe: 28-days post booster vaccination

Population: The analysis of immunogenicity endpoints included all participants with outcome data.

Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA.

Outcome measures

Outcome measures
Measure	Standard n=292 Participants 30µg Pfizer-BioNTech booster dose	Fractional n=295 Participants 15µg Pfizer-BioNTech booster dose	Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
SARS-CoV-2 Specific IgG Antibodies at Day-28	4946 BAU/ml Interval 4614.0 to 5302.0	4619 BAU/ml Interval 4292.0 to 4970.0	—	—	—	—

SECONDARY outcome

Timeframe: 28-days post booster vaccination

Population: The analysis of immunogenicity endpoints included all participants with outcome data

Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. Priming strata (previously COVID vaccination): AstraZeneca (ChAdOx1-S, or Vaxzevria®); Sinopharm (BBIBP-CorV®); Sputnik V (Gam-COVID-Vac®)

Outcome measures

Outcome measures
Measure	Standard n=65 Participants 30µg Pfizer-BioNTech booster dose	Fractional n=62 Participants 15µg Pfizer-BioNTech booster dose	Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group n=194 Participants Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group n=198 Participants Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group n=33 Participants Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group n=35 Participants Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
SARS-CoV-2 Specific IgG Antibodies at Day-28 by Priming Vaccine Strata	4394 BAU/ml Interval 3863.0 to 4997.0	4167 BAU/ml Interval 3550.0 to 4892.0	5109 BAU/ml Interval 4678.0 to 5580.0	4970 BAU/ml Interval 4541.0 to 5438.0	5160 BAU/ml Interval 4128.0 to 6450.0	3662 BAU/ml Interval 3016.0 to 4447.0

SECONDARY outcome

Timeframe: Baseline (pre booster), 28 days, 6- and 12-months post booster vaccination

Serum samples collected at baseline (pre booster), 28 days, 6- and 12-months post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG CMIA. Data will be reported as binding antibody units (BAU)/mL and presented as geometric mean concentration (GMC) and 95% confidence intervals (CI).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination

Serum samples collected at baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific neutralising antibodies using the GenScript® cPass surrogate virus neutralization test (sVNT) for both wild-type and Omicron variant. Neutralising antibody response will be reported as percentage (%) inhibition of receptor binding domain-angiotensin-converting enzyme 2 (RBD-ACE2) binding relative to a positive control.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination

A subset of samples (20%) from all four timepoints will be assessed using a SARS-CoV-2 microneutralisation assay to both the wild type (vaccine) strain and for two SARS-CoV-2 Variants of concern. Neutralizing antibody will be reported as endpoint titre.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination

Applicable to the subset participants with additional blood collection. Interferon gamma (IFNγ) concentrations as a measurement of cellular immunity will be assessed on a subset of the participants from each group. QuantiFERON Human IFN-γ SARS-CoV-2 (Qiagen) will be used to stimulate IFN-γ production in peripheral blood mononuclear cells (PBMCs) and then IFN-γ production will be measured using ELISA (enzyme-linked immunosorbent assay). Data will be presented as GMC and 95% CI.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination

Applicable to the subset participants with additional blood collection. IFNγ producing cells as a measurement of cellular immunity will be assessed on a subset of the participants (40%) from each group. IFN-γ Enzyme-Linked ImmunoSpot (Elispot) assay will be performed on isolated peripheral blood mononuclear cells (PBMCs). Data will be reported as number of IFNγ producing cells/million and presented using means and 95% CI.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months)

Frequency of cytokine-expressing T cells will be assessed on a subset of participants (40%) using flow cytometry (intracellular staining) on PBMCs samples. Data will be reported as frequency (%) of cytokine-expressing T cells presented as means and 95% CI.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination

Cytokine concentrations following PBMCs stimulation will be assessed on a subset of participants (40%) using multiplex cytokine assays.Data will be reported as cytokine concentrations in pg/ml and presented as GMC and 95% CI.IFN-γ Elispot, intracellular cytokine assays (flow cytometry) and multiplex cytokine assays will be performed on isolated PBMCs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days-post booster vaccination

Population: The reactogenicity and safety analysis populations included all randomised participants who received a study vaccine, according to the vaccine received

All unsolicited AE will be collected for 28 days post booster vaccination. Data will be presented as proportion of participants who report unsolicited AE.

Outcome measures

Outcome measures
Measure	Standard n=65 Participants 30µg Pfizer-BioNTech booster dose	Fractional n=64 Participants 15µg Pfizer-BioNTech booster dose	Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group n=200 Participants Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group n=199 Participants Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group n=34 Participants Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group n=36 Participants Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
Incidence of Unsolicited Adverse Events (AE)	5 Participants	9 Participants	12 Participants	7 Participants	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 months post booster vaccination

All participants with medically attended AE will be collected for 3 months post booster vaccination. Data will be presented as proportion of participants who report unsolicited AE.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months post booster vaccination

SAE will be collected throughout the follow-up period of 12 months post booster vaccination. Data will be presented as a proportion of participants who report unsolicited SAE.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months post booster vaccination

Confirmed COVID-19 infections will be documented throughout the follow-up period, by clinical severity.

Outcome measures

Outcome data not reported

Adverse Events

Standard Pfizer-BioNTech Booster Group- AstraZeneca

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Fractional Pfizer-BioNTech Booster Group- AstraZeneca

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Standard Pfizer-BioNTech Booster Group- Sinopharm

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Fractional Pfizer-BioNTech Booster Group- Sinopharm

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Standard Pfizer-BioNTech Booster Group- Sputnik

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Fractional Pfizer-BioNTech Booster Group- Sputnik

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Pfizer-BioNTech Booster Group- AstraZeneca n=65 participants at risk Previously received two doses of AstraZeneca as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Fractional Pfizer-BioNTech Booster Group- AstraZeneca n=65 participants at risk Previously received two doses of AstraZeneca as primary COVID-19 vaccine. Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Standard Pfizer-BioNTech Booster Group- Sinopharm n=201 participants at risk Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Fractional Pfizer-BioNTech Booster Group- Sinopharm n=200 participants at risk Previously received two doses of Sinopharm as primary COVID-19 vaccine. Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Standard Pfizer-BioNTech Booster Group- Sputnik n=34 participants at risk Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Fractional Pfizer-BioNTech Booster Group- Sputnik n=36 participants at risk Previously received two doses of Sputnik as primary COVID-19 vaccine. Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Metabolism and nutrition disorders Gout	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Hepatobiliary disorders Hepatobiliary	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	2.9% 1/34 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.

Other adverse events

Other adverse events
Measure	Standard Pfizer-BioNTech Booster Group- AstraZeneca n=65 participants at risk Previously received two doses of AstraZeneca as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Fractional Pfizer-BioNTech Booster Group- AstraZeneca n=65 participants at risk Previously received two doses of AstraZeneca as primary COVID-19 vaccine. Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Standard Pfizer-BioNTech Booster Group- Sinopharm n=201 participants at risk Previously received two doses of Sinopharm as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Fractional Pfizer-BioNTech Booster Group- Sinopharm n=200 participants at risk Previously received two doses of Sinopharm as primary COVID-19 vaccine. Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.	Standard Pfizer-BioNTech Booster Group- Sputnik n=34 participants at risk Previously received two doses of Sputnik as primary COVID-19 vaccine Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.	Fractional Pfizer-BioNTech Booster Group- Sputnik n=36 participants at risk Previously received two doses of Sputnik as primary COVID-19 vaccine. Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
Gastrointestinal disorders Abdominal cramps	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Infections and infestations Acute respiratory tract infection	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	2.8% 1/36 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Infections and infestations Acute upper respiratory tract infection	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	2.9% 1/34 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	2.8% 1/36 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Immune system disorders Allergy to chemicals	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/200 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Musculoskeletal and connective tissue disorders Arthralgia	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/200 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
General disorders Chest discomfort	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/200 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
General disorders Fatigue	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Infections and infestations Furuncle	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/200 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Nervous system disorders Headache	3.1% 2/65 • Number of events 2 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	1.00% 2/201 • Number of events 2 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	1.0% 2/200 • Number of events 2 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	2.9% 1/34 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	2.8% 1/36 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Vascular disorders Hypertension	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	5.9% 2/34 • Number of events 2 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	2.8% 1/36 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Reproductive system and breast disorders Irregular menstruation	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/200 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Social circumstances Natural menopause	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	2.9% 1/34 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Cardiac disorders Palpitations	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	2.8% 1/36 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Infections and infestations Tooth infection	0.00% 0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
Infections and infestations Upper respiratory tract infection	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	1.5% 1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.50% 1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.	0.00% 0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.

Additional Information

Kim Mulholland

Murdoch Children's Research Institute

Phone: +61 3 99366656

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place