Trial Outcomes & Findings for A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS (NCT NCT04071158)

Last Updated: 2021-02-15

Results Overview

Percentage of participants achieving Anti-TTd antibody concentrations of \>= 0.1 IU/mL at 1 month after vaccination were reported. The lower limit of quantitation (LLOQ) values for Anti-TTd was 0.05 IU/mL. Assay results below the LLOQ were set to 0.5\*LLOQ. Data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

713 participants

Primary outcome timeframe

1 month after vaccination

Results posted on

2021-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Respiratory Syncytial Virus (RSV) Vaccine 120 Microgram (mcg) With Placebo Participants received 0.5 milliliter (mL), intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 120 mcg With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Overall Study STARTED	143	143	143	143	141
Overall Study Treated	141	141	143	143	141
Overall Study Safety Population	141	141	142	144	141
Overall Study COMPLETED	140	139	140	140	136
Overall Study NOT COMPLETED	3	4	3	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Respiratory Syncytial Virus (RSV) Vaccine 120 Microgram (mcg) With Placebo Participants received 0.5 milliliter (mL), intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 120 mcg With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Overall Study Lost to Follow-up	1	2	3	3	5
Overall Study Randomized but not treated	2	2	0	0	0

Baseline Characteristics

A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RSV Vaccine 120 mcg With Placebo n=141 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 120 mcg With Tdap n=141 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo n=142 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap n=144 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=141 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Total n=709 Participants Total of all reporting groups
Age, Continuous	35.6 Years STANDARD_DEVIATION 9.2 • n=5 Participants	35.7 Years STANDARD_DEVIATION 8.7 • n=7 Participants	36.0 Years STANDARD_DEVIATION 8.3 • n=5 Participants	36.1 Years STANDARD_DEVIATION 9.1 • n=4 Participants	34.4 Years STANDARD_DEVIATION 9.2 • n=21 Participants	35.6 Years STANDARD_DEVIATION 8.9 • n=8 Participants
Sex: Female, Male Female	141 Participants n=5 Participants	141 Participants n=7 Participants	142 Participants n=5 Participants	144 Participants n=4 Participants	141 Participants n=21 Participants	709 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants	19 Participants n=4 Participants	16 Participants n=21 Participants	97 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	116 Participants n=5 Participants	125 Participants n=7 Participants	119 Participants n=5 Participants	124 Participants n=4 Participants	125 Participants n=21 Participants	609 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	41 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants	28 Participants n=7 Participants	25 Participants n=5 Participants	29 Participants n=4 Participants	38 Participants n=21 Participants	149 Participants n=8 Participants
Race (NIH/OMB) White	100 Participants n=5 Participants	98 Participants n=7 Participants	101 Participants n=5 Participants	107 Participants n=4 Participants	97 Participants n=21 Participants	503 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants

PRIMARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable immunogenicity population(EIP): participants who were eligible, received all doses of investigational product to which they were randomized, had blood drawn for assay testing within specified time frame for 1 month after vaccination, had \>=1 valid, determinate assay result at 1-month-postvaccination visit and no major protocol violations.

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=272 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=134 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Percentage of Participants Achieving Anti-Tetanus Toxoid (TTd) Antibody Concentrations of Greater Than or Equal to (>=) 0.1 International Units Per Milliliter (IU/mL) at 1 Month After Vaccination	100 Percentage of participants Interval 98.7 to 100.0	100 Percentage of participants Interval 97.3 to 100.0	—	—	—

PRIMARY outcome

Timeframe: 1 month after vaccination

Population: EIP: participants who were eligible, received all doses of investigational product to which they were randomized, have blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month-postvaccination visit and had no major protocol violations.

Percentage of participants achieving Anti-DTd antibody concentrations of \>= 0.1 IU/mL at 1 month after vaccination were reported. The LLOQ values for Anti- DTd= 0.037 IU/mL. Assay results below the LLOQ were set to 0.5\*LLOQ. Data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol.

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=272 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=134 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Percentage of Participants Achieving Anti-Diphtheria Toxoid (DTd) Antibody Concentrations of >= 0.1 IU/mL at 1 Month After Vaccination	97.4 Percentage of participants Interval 94.8 to 99.0	99.3 Percentage of participants Interval 95.9 to 100.0	—	—	—

PRIMARY outcome

Timeframe: 1 month after vaccination

GMCs of anti-pertussis components: anti pertussis (anti-PT) toxin, anti filamentous hemagglutinin (FHA) and anti- pertactin (PRN) was measured and reported in descriptive section. LLOQ values for each component was: Anti-PT=0.9 endotoxin units per milliliter (EU/mL), Anti-FHA=2.9 EU/mL, and Anti-PRN=3.0 EU/mL. Assay results below LLOQ were set to 0.5\*LLOQ. Descriptive data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=272 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=134 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Geometric Mean Concentration (GMC) and Geometric Mean Ratio (GMR) of Anti-Pertussis Antibodies 1 Month After Vaccination Anti-PT	36.59 Endotoxin unit per milliliter (EU/mL) Interval 33.1 to 40.46	45.90 Endotoxin unit per milliliter (EU/mL) Interval 37.43 to 56.29	—	—	—
Geometric Mean Concentration (GMC) and Geometric Mean Ratio (GMR) of Anti-Pertussis Antibodies 1 Month After Vaccination Anti-FHA	113.30 Endotoxin unit per milliliter (EU/mL) Interval 104.13 to 123.28	191.33 Endotoxin unit per milliliter (EU/mL) Interval 164.46 to 222.59	—	—	—
Geometric Mean Concentration (GMC) and Geometric Mean Ratio (GMR) of Anti-Pertussis Antibodies 1 Month After Vaccination Anti-PRN	154.13 Endotoxin unit per milliliter (EU/mL) Interval 135.98 to 174.7	257.05 Endotoxin unit per milliliter (EU/mL) Interval 211.55 to 312.34	—	—	—

PRIMARY outcome

Timeframe: 1 month after vaccination

Assay results below the LLOQ were set to 0.5\*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=272 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=270 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin	22339.0 Titer Interval 20362.3 to 24507.6	22980.1 Titer Interval 20371.3 to 25922.9	—	—	—

PRIMARY outcome

Timeframe: 1 month after vaccination

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=272 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=271 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin	21509.7 Titer Interval 19279.4 to 23997.9	22486.0 Titer Interval 19696.2 to 25671.0	—	—	—

PRIMARY outcome

Timeframe: Within 7 days after vaccination

Population: Safety analysis set included all randomized participants who received investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Local reactions included pain at injection site, redness and swelling recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=141 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=141 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo n=141 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap n=143 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=139 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination Swelling: moderate	2.8 Percentage of participants Interval 0.8 to 7.1	1.4 Percentage of participants Interval 0.2 to 5.0	2.1 Percentage of participants Interval 0.4 to 6.1	3.5 Percentage of participants Interval 1.1 to 8.0	0.7 Percentage of participants Interval 0.0 to 3.9
Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination Pain at injection site: mild	33.3 Percentage of participants Interval 25.6 to 41.8	34.0 Percentage of participants Interval 26.3 to 42.5	46.1 Percentage of participants Interval 37.7 to 54.7	46.9 Percentage of participants Interval 38.5 to 55.4	21.6 Percentage of participants Interval 15.1 to 29.4
Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination Pain at injection site: moderate	7.1 Percentage of participants Interval 3.5 to 12.7	9.9 Percentage of participants Interval 5.5 to 16.1	19.9 Percentage of participants Interval 13.6 to 27.4	15.4 Percentage of participants Interval 9.9 to 22.4	4.3 Percentage of participants Interval 1.6 to 9.2
Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination Pain at injection site: severe	0 Percentage of participants Interval 0.0 to 2.6	0.7 Percentage of participants Interval 0.0 to 3.9	0.7 Percentage of participants Interval 0.0 to 3.9	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination Redness: mild	6.4 Percentage of participants Interval 3.0 to 11.8	3.5 Percentage of participants Interval 1.2 to 8.1	4.3 Percentage of participants Interval 1.6 to 9.0	2.8 Percentage of participants Interval 0.8 to 7.0	0.7 Percentage of participants Interval 0.0 to 3.9
Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination Redness: moderate	0.7 Percentage of participants Interval 0.0 to 3.9	0.7 Percentage of participants Interval 0.0 to 3.9	0.7 Percentage of participants Interval 0.0 to 3.9	2.8 Percentage of participants Interval 0.8 to 7.0	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination Redness: severe	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination Swelling: mild	4.3 Percentage of participants Interval 1.6 to 9.0	4.3 Percentage of participants Interval 1.6 to 9.0	2.1 Percentage of participants Interval 0.4 to 6.1	3.5 Percentage of participants Interval 1.1 to 8.0	0.7 Percentage of participants Interval 0.0 to 3.9
Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination Swelling: severe	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.6

PRIMARY outcome

Timeframe: Within 7 days after vaccination

Systemic reactions included fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever was categorized as: \>=38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=141 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=141 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo n=141 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap n=143 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=139 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Diarrhea: severe	0 Percentage of participants Interval 0.0 to 2.6	0.7 Percentage of participants Interval 0.0 to 3.9	1.4 Percentage of participants Interval 0.2 to 5.0	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Fever: >=38.0 degree C	7.8 Percentage of participants Interval 4.0 to 13.5	6.4 Percentage of participants Interval 3.0 to 11.8	6.4 Percentage of participants Interval 3.0 to 11.8	7.7 Percentage of participants Interval 3.9 to 13.3	5.0 Percentage of participants Interval 2.0 to 10.1
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Fever: mild	4.3 Percentage of participants Interval 1.6 to 9.0	3.5 Percentage of participants Interval 1.2 to 8.1	5.7 Percentage of participants Interval 2.5 to 10.9	2.8 Percentage of participants Interval 0.8 to 7.0	3.6 Percentage of participants Interval 1.2 to 8.2
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Fever: moderate	2.1 Percentage of participants Interval 0.4 to 6.1	1.4 Percentage of participants Interval 0.2 to 5.0	0.7 Percentage of participants Interval 0.0 to 3.9	3.5 Percentage of participants Interval 1.1 to 8.0	0.7 Percentage of participants Interval 0.0 to 3.9
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Fever: severe	1.4 Percentage of participants Interval 0.2 to 5.0	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.6	1.4 Percentage of participants Interval 0.2 to 5.0	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Fever: Grade 4	0 Percentage of participants Interval 0.0 to 2.6	1.4 Percentage of participants Interval 0.2 to 5.0	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.5	0.7 Percentage of participants Interval 0.0 to 3.9
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Fatigue: mild	20.6 Percentage of participants Interval 14.2 to 28.2	24.1 Percentage of participants Interval 17.3 to 32.0	21.3 Percentage of participants Interval 14.8 to 29.0	23.1 Percentage of participants Interval 16.4 to 30.9	26.6 Percentage of participants Interval 19.5 to 34.8
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Fatigue: moderate	19.1 Percentage of participants Interval 13.0 to 26.6	22.0 Percentage of participants Interval 15.5 to 29.7	22.7 Percentage of participants Interval 16.1 to 30.5	22.4 Percentage of participants Interval 15.8 to 30.1	17.3 Percentage of participants Interval 11.4 to 24.6
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Fatigue: severe	2.8 Percentage of participants Interval 0.8 to 7.1	2.1 Percentage of participants Interval 0.4 to 6.1	0.7 Percentage of participants Interval 0.0 to 3.9	1.4 Percentage of participants Interval 0.2 to 5.0	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Headache: mild	17.0 Percentage of participants Interval 11.2 to 24.3	20.6 Percentage of participants Interval 14.2 to 28.2	27.0 Percentage of participants Interval 19.8 to 35.1	24.5 Percentage of participants Interval 17.7 to 32.4	20.1 Percentage of participants Interval 13.8 to 27.8
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Headache: moderate	16.3 Percentage of participants Interval 10.6 to 23.5	19.9 Percentage of participants Interval 13.6 to 27.4	17.7 Percentage of participants Interval 11.8 to 25.1	14.7 Percentage of participants Interval 9.3 to 21.6	15.8 Percentage of participants Interval 10.2 to 23.0
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Headache: severe	2.1 Percentage of participants Interval 0.4 to 6.1	1.4 Percentage of participants Interval 0.2 to 5.0	1.4 Percentage of participants Interval 0.2 to 5.0	2.1 Percentage of participants Interval 0.4 to 6.0	0.7 Percentage of participants Interval 0.0 to 3.9
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Nausea: mild	9.9 Percentage of participants Interval 5.5 to 16.1	11.3 Percentage of participants Interval 6.6 to 17.8	9.9 Percentage of participants Interval 5.5 to 16.1	12.6 Percentage of participants Interval 7.6 to 19.2	13.7 Percentage of participants Interval 8.4 to 20.5
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Nausea: moderate	12.1 Percentage of participants Interval 7.2 to 18.6	5.7 Percentage of participants Interval 2.5 to 10.9	5.7 Percentage of participants Interval 2.5 to 10.9	7.0 Percentage of participants Interval 3.4 to 12.5	7.9 Percentage of participants Interval 4.0 to 13.7
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Nausea: severe	0.7 Percentage of participants Interval 0.0 to 3.9	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Muscle pain: mild	19.1 Percentage of participants Interval 13.0 to 26.6	33.3 Percentage of participants Interval 25.6 to 41.8	31.9 Percentage of participants Interval 24.3 to 40.3	30.1 Percentage of participants Interval 22.7 to 38.3	23.0 Percentage of participants Interval 16.3 to 30.9
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Muscle pain: moderate	15.6 Percentage of participants Interval 10.0 to 22.7	15.6 Percentage of participants Interval 10.0 to 22.7	15.6 Percentage of participants Interval 10.0 to 22.7	22.4 Percentage of participants Interval 15.8 to 30.1	11.5 Percentage of participants Interval 6.7 to 18.0
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Muscle pain: severe	0 Percentage of participants Interval 0.0 to 2.6	0.7 Percentage of participants Interval 0.0 to 3.9	0.7 Percentage of participants Interval 0.0 to 3.9	0.7 Percentage of participants Interval 0.0 to 3.8	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Joint pain: mild	7.8 Percentage of participants Interval 4.0 to 13.5	11.3 Percentage of participants Interval 6.6 to 17.8	9.2 Percentage of participants Interval 5.0 to 15.3	9.1 Percentage of participants Interval 4.9 to 15.0	4.3 Percentage of participants Interval 1.6 to 9.2
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Joint pain: moderate	7.1 Percentage of participants Interval 3.5 to 12.7	6.4 Percentage of participants Interval 3.0 to 11.8	7.8 Percentage of participants Interval 4.0 to 13.5	8.4 Percentage of participants Interval 4.4 to 14.2	7.2 Percentage of participants Interval 3.5 to 12.8
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Joint pain: severe	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Vomiting: mild	3.5 Percentage of participants Interval 1.2 to 8.1	4.3 Percentage of participants Interval 1.6 to 9.0	0.7 Percentage of participants Interval 0.0 to 3.9	2.1 Percentage of participants Interval 0.4 to 6.0	2.2 Percentage of participants Interval 0.4 to 6.2
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Vomiting: moderate	0 Percentage of participants Interval 0.0 to 2.6	0.7 Percentage of participants Interval 0.0 to 3.9	0.7 Percentage of participants Interval 0.0 to 3.9	0 Percentage of participants Interval 0.0 to 2.5	2.2 Percentage of participants Interval 0.4 to 6.2
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Vomiting: severe	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.6	0.7 Percentage of participants Interval 0.0 to 3.9	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Diarrhea: mild	12.1 Percentage of participants Interval 7.2 to 18.6	13.5 Percentage of participants Interval 8.3 to 20.2	9.2 Percentage of participants Interval 5.0 to 15.3	10.5 Percentage of participants Interval 6.0 to 16.7	10.1 Percentage of participants Interval 5.6 to 16.3
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Diarrhea: moderate	3.5 Percentage of participants Interval 1.2 to 8.1	5.0 Percentage of participants Interval 2.0 to 10.0	1.4 Percentage of participants Interval 0.2 to 5.0	6.3 Percentage of participants Interval 2.9 to 11.6	5.0 Percentage of participants Interval 2.0 to 10.1

PRIMARY outcome

Timeframe: Within 1 month after vaccination (up to 35 days)

Population: Safety analysis set included all randomized participants who received investigational product.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=141 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=141 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo n=142 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap n=144 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=141 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination	5.7 Percentage of participants Interval 2.5 to 10.9	7.8 Percentage of participants Interval 4.0 to 13.5	5.6 Percentage of participants Interval 2.5 to 10.8	10.4 Percentage of participants Interval 5.9 to 16.6	9.2 Percentage of participants Interval 5.0 to 15.3

PRIMARY outcome

Timeframe: Within 1 month after vaccination (up to 35 days)

Population: Safety analysis set included all randomized participants who received investigational product.

An medically attended adverse events (MAE) was defined as a non-serious AE that results in an evaluation at a medical facility. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=141 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=141 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo n=142 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap n=144 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=141 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Percentage of Participants With Medically Attended Adverse Events (MAE) and Serious Adverse Events (SAE) SAE	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.6	0.7 Percentage of participants Interval 0.0 to 3.9	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Medically Attended Adverse Events (MAE) and Serious Adverse Events (SAE) MAE	1.4 Percentage of participants Interval 0.2 to 5.0	0 Percentage of participants Interval 0.0 to 2.6	0 Percentage of participants Interval 0.0 to 2.6	1.4 Percentage of participants Interval 0.2 to 4.9	2.1 Percentage of participants Interval 0.4 to 6.1

SECONDARY outcome

Timeframe: 1 month after vaccination

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=272 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=270 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin	22339.0 Titer Interval 20362.3 to 24507.6	22980.1 Titer Interval 20371.3 to 25922.9	—	—	—

SECONDARY outcome

Timeframe: 1 month after vaccination

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=272 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=271 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin	21509.7 Titer Interval 19279.4 to 23997.9	22486.0 Titer Interval 19696.2 to 25671.0	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Before vaccination on Day 1

Percentage of participants achieving Anti-TTd antibody concentrations of \>= 0.1 IU/mL 1 month before vaccination were reported. The LLOQ values for Anti-TTd = 0.05 IU/mL. Assay results below the LLOQ were set to 0.5\*LLOQ. Data for this outcome measure was not planned to be collected and analyzed for RSV 120 mcg with placebo arm and RSV 240 mcg with aluminum hydroxide/placebo arm.

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=135 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=137 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo n=134 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Percentage of Participants Achieving Anti-TTd Antibody Concentrations of >= 0.1 IU/mL Before Vaccination	97.8 Percentage of participants Interval 93.6 to 99.5	96.4 Percentage of participants Interval 91.7 to 98.8	99.3 Percentage of participants Interval 95.9 to 100.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Before vaccination on Day 1

Percentage of participants achieving Anti-DTd antibody concentrations of \>= 0.1 IU/mL before vaccination were reported. The LLOQ values for Anti-DTd= 0.037 IU/mL. Assay results below the LLOQ were set to 0.5\*LLOQ. Data for this outcome measure was not planned to be collected and analyzed for RSV 120 mcg with placebo arm and RSV 240 mcg with aluminum hydroxide/placebo arm.

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=135 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=137 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo n=134 Participants Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Percentage of Participants Achieving Anti- DTd Antibody Concentrations of >= 0.1 IU/mL Before Vaccination	83.0 Percentage of participants Interval 75.5 to 88.9	78.8 Percentage of participants Interval 71.0 to 85.3	82.1 Percentage of participants Interval 74.5 to 88.2	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Before vaccination on Day 1

Assay results below the LLOQ were set to 0.5\*LLOQ. Titers were expressed in terms of 1/dilution. Data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol.

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=272 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=271 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies Before Vaccination	1582.6 Titer Interval 1450.3 to 1726.9	1560.6 Titer Interval 1419.4 to 1715.8	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Before vaccination on Day 1

Outcome measures

Outcome measures
Measure	RSV Vaccine With Aluminum Hydroxide With Tdap n=272 Participants This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap or RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=271 Participants Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before Vaccination	1470.2 Titer Interval 1343.6 to 1608.7	1417.3 Titer Interval 1284.8 to 1563.5	—	—	—

Adverse Events

RSV Vaccine 120 mcg With Placebo

Serious events: 0 serious events

Other events: 103 other events

Deaths: 0 deaths

RSV Vaccine 120 mcg With Tdap

Serious events: 0 serious events

Other events: 114 other events

Deaths: 0 deaths

RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo

Serious events: 1 serious events

Other events: 118 other events

Deaths: 0 deaths

RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap

Serious events: 0 serious events

Other events: 119 other events

Deaths: 0 deaths

Placebo/Tdap

Serious events: 0 serious events

Other events: 106 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RSV Vaccine 120 mcg With Placebo n=141 participants at risk Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 120 mcg With Tdap n=141 participants at risk Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo n=142 participants at risk Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap n=144 participants at risk Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=141 participants at risk Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.70% 1/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Other adverse events

Other adverse events
Measure	RSV Vaccine 120 mcg With Placebo n=141 participants at risk Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 120 mcg With Tdap n=141 participants at risk Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo n=142 participants at risk Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination.	RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap n=144 participants at risk Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination.	Placebo/Tdap n=141 participants at risk Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.70% 1/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Endocrine disorders Hypothyroidism	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Abdominal pain upper	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Constipation	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Diarrhoea	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.70% 1/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Haemorrhoids	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Nausea	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Tooth impacted	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Toothache	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Vomiting	3.5% 5/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.0% 7/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	2.1% 3/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	2.1% 3/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.3% 6/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Axillary pain	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Fatigue	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	2.1% 3/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Injection site erythema	7.1% 10/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.3% 6/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.9% 7/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.6% 8/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Injection site pain	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Injection site swelling	7.1% 10/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.7% 8/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.2% 6/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.9% 10/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.4% 2/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Pyrexia	7.8% 11/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.4% 9/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	6.3% 9/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.6% 11/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	5.0% 7/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Swelling	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Immune system disorders Seasonal allergy	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Bacterial vaginosis	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.70% 1/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Nasopharyngitis	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.70% 1/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.4% 2/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Oral herpes	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Ear infection	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Pharyngitis streptococcal	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Sinusitis bacterial	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Sinusitis	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Tonsillitis	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Tooth infection	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.70% 1/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Upper respiratory tract infection	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.4% 2/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.4% 2/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	2.8% 4/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Urinary tract infection	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Concussion	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Contusion	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Hand fracture	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Venomous sting	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.70% 1/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Myalgia	34.8% 49/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	49.6% 70/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	47.9% 68/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	52.8% 76/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	34.0% 48/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Neck pain	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Dizziness	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Headache	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.4% 2/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Migraine	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.4% 2/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Neuropathy peripheral	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Psychiatric disorders Depression	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.4% 2/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.70% 1/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pharyngeal mass	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.69% 1/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/142 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/144 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.71% 1/141 • Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER