Trial Outcomes & Findings for Assessing Immune Response of Different COVID-19 Vaccines in Older Adults (NCT NCT05160766)

Last Updated: 2025-05-20

Results Overview

Rate of 2-fold antibody titre increase 14 days after 3rd (Part A) or 4th vaccination dose (Part B) measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

323 participants

Primary outcome timeframe

From Day 0 until Day 14

Results posted on

2025-05-20

Participant Flow

Due to poor recruitment, Part A of the trial (3rd COVID-19 vaccination) was closed to further enrolment on 13 Jan 2022. Part B (4th COVID-19 vaccination) started on 21 Jan 2022. In Part A, one randomised subject did not receive the allocated intervention (mRNA-1273) due to an acute onset of SARS-CoV-2 infection. Both Part A and B belong to one trial and fall under one NCT number.

Participant milestones

Participant milestones
Measure	BNT162b2 (Part A) Part A: Participants were pre-vaccinated with 2 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).	mRNA-1273 (Part A) Part A: Participants were pre-vaccinated with 2 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).	BTN162b2 (Part B) Part B: Participants were pre-vaccinated with 3 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 + BNT162b2 BNT162b2 + BNT162b2 + mRNA-1273 mRNA-1273 + mRNA-1273 + mRNA-1273 mRNA-1273 + mRNA-1273 + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + mRNA-1273 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).	mRNA-1273 (Part B) Part B: Participants were pre-vaccinated with 3 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 + BNT162b2 BNT162b2 + BNT162b2 + mRNA-1273 mRNA-1273 + mRNA-1273 + mRNA-1273 mRNA-1273 + mRNA-1273 + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + mRNA-1273 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).
Overall Study STARTED	25	27	135	135
Overall Study COMPLETED	21	20	126	123
Overall Study NOT COMPLETED	4	7	9	12

Reasons for withdrawal

Reasons for withdrawal
Measure	BNT162b2 (Part A) Part A: Participants were pre-vaccinated with 2 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).	mRNA-1273 (Part A) Part A: Participants were pre-vaccinated with 2 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).	BTN162b2 (Part B) Part B: Participants were pre-vaccinated with 3 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 + BNT162b2 BNT162b2 + BNT162b2 + mRNA-1273 mRNA-1273 + mRNA-1273 + mRNA-1273 mRNA-1273 + mRNA-1273 + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + mRNA-1273 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).	mRNA-1273 (Part B) Part B: Participants were pre-vaccinated with 3 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 + BNT162b2 BNT162b2 + BNT162b2 + mRNA-1273 mRNA-1273 + mRNA-1273 + mRNA-1273 mRNA-1273 + mRNA-1273 + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + mRNA-1273 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).
Overall Study Adverse Event	0	1	0	0
Overall Study COVID-19 infection	0	1	0	0
Overall Study travel time	1	0	0	1
Overall Study Withdrawal by Subject	3	5	4	2
Overall Study Death	0	0	2	5
Overall Study Lost to Follow-up	0	0	1	2
Overall Study No show	0	0	1	1
Overall Study Physician Decision	0	0	0	1
Overall Study Protocol Violation	0	0	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BNT162b2 (Part A) n=25 Participants Part A: Participants were pre-vaccinated with 2 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).	mRNA-1273 (Part A) n=27 Participants Part A: Participants were pre-vaccinated with 2 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 mRNA-1273 + mRNA-1273 ChAdOx-1-S + ChAdOx-1-S A 3rd dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).	BNT162b2 (Part B) n=135 Participants Part B: Participants were pre-vaccinated with 3 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 + BNT162b2 BNT162b2 + BNT162b2 + mRNA-1273 mRNA-1273 + mRNA-1273 + mRNA-1273 mRNA-1273 + mRNA-1273 + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + mRNA-1273 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).	mRNA-1273 (Part B) n=135 Participants Part B: Participants were pre-vaccinated with 3 vaccinations when entering the trial, as follows: BNT162b2 + BNT162b2 + BNT162b2 BNT162b2 + BNT162b2 + mRNA-1273 mRNA-1273 + mRNA-1273 + mRNA-1273 mRNA-1273 + mRNA-1273 + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + mRNA-1273 A 4th dose was administered in the study, either Comirnaty (BTN162b2) or Spikevax (mRNA-1273).	Total n=322 Participants Total of all reporting groups
Age, Continuous	77 years n=25 Participants	78 years n=27 Participants	79 years n=135 Participants	79 years n=135 Participants	79 years n=322 Participants
Sex: Female, Male Female	9 Participants n=25 Participants	11 Participants n=27 Participants	67 Participants n=135 Participants	68 Participants n=135 Participants	155 Participants n=322 Participants
Sex: Female, Male Male	16 Participants n=25 Participants	16 Participants n=27 Participants	68 Participants n=135 Participants	67 Participants n=135 Participants	167 Participants n=322 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Height	171 cm n=25 Participants	174 cm n=27 Participants	169 cm n=135 Participants	169 cm n=135 Participants	169 cm n=322 Participants
Weight	75 kg n=25 Participants	73 kg n=27 Participants	72 kg n=135 Participants	75 kg n=135 Participants	74 kg n=322 Participants
BMI	25.6 kg/m2 n=25 Participants	24.1 kg/m2 n=27 Participants	25.4 kg/m2 n=135 Participants	25.4 kg/m2 n=135 Participants	25.4 kg/m2 n=322 Participants
Duration between 1st and 2nd vaccination in days	42 days n=25 Participants	42 days n=27 Participants	22 days n=135 Participants	22 days n=135 Participants	22 days n=322 Participants
Duration between 2nd and 3rd vaccination in days	192 days n=25 Participants	190 days n=27 Participants	207 days n=135 Participants	205 days n=135 Participants	206.5 days n=322 Participants

PRIMARY outcome

Timeframe: From Day 0 until Day 14

Population: All primary analyses were performed on the mITT population set. The primary endpoint was the rate π of 2-fold IgG antibody titre increase following a 3rd (Part A) or 4th dose vaccination (Part B) measured by quantitative enzyme-linked electrochemiluminescent immunoassay (Anti-RBD-ELISA) against wild-type virus at 14 days after study vaccination (versus immediately before vaccination).

Rate of 2-fold antibody titre increase 14 days after 3rd (Part A) or 4th vaccination dose (Part B) measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus.

Outcome measures

Outcome measures
Measure	BNT162b2 (Part A) n=25 Participants vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=25 Participants vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=130 Participants vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=133 Participants vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Antibody Titre Increase 14 Days After Study Vaccination Dose.	100 percentage of participants Interval 83.9 to 100.0	100 percentage of participants Interval 83.9 to 100.0	78.46 percentage of participants Interval 69.2 to 86.0	87.22 percentage of participants Interval 79.3 to 93.0

SECONDARY outcome

Timeframe: From Day 0 until Day 14

Population: Number of subjects for whom the difference of neutralizing activity (Day 14 minus Day 0) could be calculated.

Change in neutralizing antibody titre (Virus Neutralisation Assay) against wild-type 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities.

Outcome measures

Outcome measures
Measure	BNT162b2 (Part A) n=21 Participants vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=20 Participants vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=122 Participants vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=120 Participants vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Change in Neutralizing Antibody Titre Against Wild-type 14 Days After Study Vaccination Dose	58.49 percentage of inhibition Standard Deviation 16.25	65.98 percentage of inhibition Standard Deviation 18.32	37.33 percentage of inhibition Standard Deviation 22.93	41.45 percentage of inhibition Standard Deviation 24.09

SECONDARY outcome

Timeframe: From Day 0 until Day 14

Change in neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities.

Outcome measures

Outcome measures
Measure	BNT162b2 (Part A) n=21 Participants vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=20 Participants vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=122 Participants vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=120 Participants vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Change in Neutralizing Antibody Titre Against Variants of Concern 14 Days After Study Vaccination Dose	49.86 percentage of inhibition Standard Deviation 17.62	57.39 percentage of inhibition Standard Deviation 19.77	38.17 percentage of inhibition Standard Deviation 21.74	44.04 percentage of inhibition Standard Deviation 23.94

SECONDARY outcome

Timeframe: From Day 0 until Month 12

Population: Subjects in whom a blood sampling was performed at Month 12.

Antibody titre level at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B) measured by a quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA assay).

Outcome measures

Outcome measures
Measure	BNT162b2 (Part A) n=21 Participants vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=21 Participants vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=125 Participants vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=121 Participants vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Antibody Titre Level at 12 Months After a Study Vaccination Dose	9319.7 IU/ml Standard Deviation 25896.27	14163.81 IU/ml Standard Deviation 46209.35	9961.92 IU/ml Standard Deviation 26292.23	12024.3 IU/ml Standard Deviation 29129.18

SECONDARY outcome

Timeframe: From Day 0 until Month 12

Population: Titres of neutralizing antibodies were reported as change in neutralization capacity.

Neutralizing antibody titre (Virus Neutralisation Assay) against wild-type SARS-CoV-2 at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities.

Outcome measures

Outcome measures
Measure	BNT162b2 (Part A) n=21 Participants vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=20 Participants vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=120 Participants vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=120 Participants vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Neutralizing Antibody Titre Against Wild-type at 12 Months After Study Vaccination Dose	54.5 percentage of inhibition Standard Deviation 33.64	62.65 percentage of inhibition Standard Deviation 33.26	12.93 percentage of inhibition Standard Deviation 39.29	18.15 percentage of inhibition Standard Deviation 33.24

SECONDARY outcome

Timeframe: From Day 0 until Month 12

Population: Titres of neutralizing antibodies were reported as change in neutralization capacity. Provided values refer to the variant "B.1.1.7 (alpha)". Besides for B.1.1.7 (alpha), all tests described above were also conducted for the following variants of concern: B.1.351 (beta), P.1 (gamma), BA.1 (omicron), BA.4 (omicron), BA.4.6 (omicron), and BA.5 (omicron). For values of these variants of concern, please see the open-access publication.

Neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities.

Outcome measures

Outcome measures
Measure	BNT162b2 (Part A) n=21 Participants vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=20 Participants vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=119 Participants vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=120 Participants vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Neutralizing Antibody Titre Against Variants of Concern at 12 Months After Study Vaccination Dose	40.59 percentage of inhibition Standard Deviation 35.37	49 percentage of inhibition Standard Deviation 36.37	15.76 percentage of inhibition Standard Deviation 38.4	20.24 percentage of inhibition Standard Deviation 37.24

OTHER_PRE_SPECIFIED outcome

Timeframe: From Day 0 until Month 12

Number of Participants with Unsolicited AEs until the end of trial

Outcome measures

Outcome measures
Measure	BNT162b2 (Part A) n=25 Participants vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=27 Participants vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=135 Participants vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=135 Participants vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Number of Participants With Unsolicited AEs	22 Participants	26 Participants	110 Participants	112 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From Day 0 until Day 7

Number of Participants with Solicited AEs for 7 days after study vaccination dose.

Outcome measures

Outcome measures
Measure	BNT162b2 (Part A) n=25 Participants vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=27 Participants vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=135 Participants vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=135 Participants vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Number of Participants With Solicited AEs	20 Participants	25 Participants	76 Participants	80 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From Day 0 until Month 3

Population: Provided values refer to SAEs related to the IMP. All other trial data is available upon request.

Number of Participants with Rate of serious adverse events (SAEs) Grade ≥3 according to the National Cancer Institute Common Toxicity Criteria up to three months after study vaccination dose.

Outcome measures

Outcome measures
Measure	BNT162b2 (Part A) n=25 Participants vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=27 Participants vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=135 Participants vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=135 Participants vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Number of Participants With Rate of SAEs Grade ≥3	0 Participants	0 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From Day 0 until Day 14

Population: Inclusion required completed visits at Day 0 and Day 14 with a sufficient number of aliquots as per CTP. Provided results are absolute values of the cellular immune response on Day 14 of tubes stimulated with peptides from spike (tube A). Samples were also stimulated with peptides from a virus membrane nucleoprotein (tube B) and with peptides from the Omicron variant (tube C). All trial results will be provided upon request.

Change in cellular immune response (CD4+ and CD8+ T cell response) to SARS-CoV-2 measured by fold change of CXCL10 mRNA levels measured by qPCR after 4th vaccination dose, to be determined in a subgroup only.

Outcome measures

Outcome measures
Measure	BNT162b2 (Part A) n=79 Participants vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=92 Participants vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Change in Cellular Immune Response Measured by qPCR 14 Days After 4th Vaccination Dose	26.63 Fold change of CXCL10 mRNA levels Standard Deviation 1.58	26.63 Fold change of CXCL10 mRNA levels Standard Deviation 1.59	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From Day 0 until Month 12

Population: Titres of neutralizing antibodies were reported as change in neutralization capacity. Provided values refer to the VoI "XBB.1 (omicron)".

"Neutralizing antibody titre (Virus Neutralisation Assay)" against newly emerging variants in bio-banked samples after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only. Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities.

Outcome measures

Outcome measures
Measure	BNT162b2 (Part A) n=21 Participants vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=20 Participants vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=120 Participants vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=120 Participants vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Neutralizing Antibody Titre Against Newly Emerging Variants in Bio-banked Samples After Study Vaccination Dose	19.28 percentage of inhibition Standard Deviation 30.94	27.18 percentage of inhibition Standard Deviation 28.14	16.75 percentage of inhibition Standard Deviation 34.24	19.03 percentage of inhibition Standard Deviation 33.01

Adverse Events

BNT162b2 (Part A)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

mRNA-1273 (Part A)

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

BNT162b2 (Part B)

Serious events: 21 serious events

Other events: 103 other events

Deaths: 2 deaths

mRNA-1273 (Part B)

Serious events: 22 serious events

Other events: 110 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Prof. Dr. med. Oliver A. Cornely

University Hospital Cologne

Phone: 0049 221 478 85523

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	BNT162b2 (Part A) n=25 participants at risk vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=27 participants at risk vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=135 participants at risk vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=135 participants at risk vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Cardiac disorders Acute myocardial infarction	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Angina pectoris	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Arrhythmia	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Atrial fibrillation	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	2.2% 3/135 • Number of events 4 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Atrioventricular block	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Bradycardia	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Cardiac failure	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	1.5% 2/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Cardiac failure congestive	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Cardio-respiratory arrest	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Sinus node dysfunction	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Ear and labyrinth disorders Vertigo positional	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Eye disorders Amaurosis fugax	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Eye disorders Glaucoma	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Eye disorders Visual impairment	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Gastrointestinal disorders Umbilical hernia	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Chest pain	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Chills	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Malaise	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Infections and infestations Abdominal sepsis	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Infections and infestations COVID-19	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Infections and infestations Cystitis	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Infections and infestations Diarrhoea infectious	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Infections and infestations Lower respiratory tract infection	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	1.5% 2/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Infections and infestations Pneumonia	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	2.2% 3/135 • Number of events 5 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Infections and infestations Sepsis	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Infections and infestations Urinary tract infection	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Infections and infestations Urosepsis	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	1.5% 2/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Injury, poisoning and procedural complications Concussion	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Injury, poisoning and procedural complications Fall	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Injury, poisoning and procedural complications Hip fracture	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Musculoskeletal and connective tissue disorders Femoral neck fracture	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Musculoskeletal and connective tissue disorders Pelvic fracture	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).

Other adverse events
Measure	BNT162b2 (Part A) n=25 participants at risk vaccination with BNT162b2 as 3rd vaccination Comirnaty (BTN162b2): Single booster shot (3rd dose)	mRNA-1273 (Part A) n=27 participants at risk vaccination with mRNA-1273 as 3rd vaccination Spikevax (mRNA-1273): Single booster shot (3rd dose)	BNT162b2 (Part B) n=135 participants at risk vaccination with BNT162b2 as 4th vaccination Comirnaty (BTN162b2): Single booster shot (4th dose)	mRNA-1273 (Part B) n=135 participants at risk vaccination with mRNA-1273 as 4th vaccination Spikevax (mRNA-1273): Single booster shot (4th dose)
Blood and lymphatic system disorders Anaemia	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	1.5% 2/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	1.5% 2/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Blood and lymphatic system disorders Anaemia megaloblastic	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Blood and lymphatic system disorders Lymphadenopathy	4.0% 1/25 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	3.7% 1/27 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Arrhythmia	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Atrial fibrillation	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	1.5% 2/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Atrial flutter	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Cardiac failure	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	1.5% 2/135 • Number of events 3 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Cardiac disorders Palpitations	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Ear and labyrinth disorders Ear pain	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Ear and labyrinth disorders Vertigo	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	3.0% 4/135 • Number of events 4 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	3.0% 4/135 • Number of events 4 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Ear and labyrinth disorders Vertigo positional	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Eye disorders Blindness unilateral	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Eye disorders Eye irritation	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Eye disorders Eye oedema	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Eye disorders Eye pain	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Ear and labyrinth disorders Myopic chorioretinal degeneration	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Gastrointestinal disorders Abdominal pain	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Gastrointestinal disorders Constipation	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Gastrointestinal disorders Diarrhoea	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	1.5% 2/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	4.4% 6/135 • Number of events 6 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Gastrointestinal disorders Inguinal hernia	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Gastrointestinal disorders Lip dry	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Gastrointestinal disorders Nausea	8.0% 2/25 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	11.1% 3/27 • Number of events 4 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	5.9% 8/135 • Number of events 9 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
Gastrointestinal disorders Vomiting	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Asthenia	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	10.4% 14/135 • Number of events 14 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	11.9% 16/135 • Number of events 19 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Chills	4.0% 1/25 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	18.5% 5/27 • Number of events 5 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	4.4% 6/135 • Number of events 6 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	5.9% 8/135 • Number of events 8 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Discomfort	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	3.7% 1/27 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Extensive swelling of vaccinated limb	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	3.0% 4/135 • Number of events 4 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Fatigue	28.0% 7/25 • Number of events 7 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	51.9% 14/27 • Number of events 16 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	23.0% 31/135 • Number of events 35 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	37.8% 51/135 • Number of events 57 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Feeling cold	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	3.7% 1/27 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Feeling hot	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Injection site dysaesthesia	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Injection site erythema	8.0% 2/25 • Number of events 3 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	14.8% 4/27 • Number of events 5 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	5.9% 8/135 • Number of events 8 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	14.8% 20/135 • Number of events 22 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Injection site haematoma	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Injection site induration	24.0% 6/25 • Number of events 6 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	37.0% 10/27 • Number of events 12 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.74% 1/135 • Number of events 1 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Injection site pain	28.0% 7/25 • Number of events 7 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	18.5% 5/27 • Number of events 5 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	40.0% 54/135 • Number of events 55 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	43.7% 59/135 • Number of events 62 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Injection site pruritus	12.0% 3/25 • Number of events 3 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	18.5% 5/27 • Number of events 5 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	6.7% 9/135 • Number of events 9 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	6.7% 9/135 • Number of events 9 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Injection site swelling	8.0% 2/25 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	25.9% 7/27 • Number of events 7 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	7.4% 10/135 • Number of events 10 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	11.1% 15/135 • Number of events 15 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).
General disorders Injection site urticaria	0.00% 0/25 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/27 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	0.00% 0/135 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).	1.5% 2/135 • Number of events 2 • AEs were documented starting from baseline visit (Day 0) and until the last scheduled visit after the study vaccine dose (Month 12).