Trial Outcomes & Findings for A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007) (NCT NCT01073293)

NCT ID: NCT01073293

Last Updated: 2018-11-27

Results Overview

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1054 participants
• Primary outcome timeframe: 4 weeks following Month 6 vaccination
• Results posted on: 2018-11-27

Participant Flow

Participant milestones

Measure	Concomitant Vaccination V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Overall Study STARTED	526	528
Overall Study COMPLETED	521	517
Overall Study NOT COMPLETED	5	11

Reasons for withdrawal

Measure	Concomitant Vaccination V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	5	10

Baseline Characteristics

A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)

Baseline characteristics by cohort

Measure	Concomitant Vaccination n=526 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=528 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	Total n=1054 Participants Total of all reporting groups
Age, Continuous	12.4 Years STANDARD_DEVIATION 1.2 • n=5 Participants	12.4 Years STANDARD_DEVIATION 1.2 • n=7 Participants	12.4 Years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	264 Participants n=5 Participants	264 Participants n=7 Participants	528 Participants n=5 Participants
Sex: Female, Male Male	262 Participants n=5 Participants	264 Participants n=7 Participants	526 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks following Month 6 vaccination

Population: The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint

Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.

Outcome measures

Measure	Concomitant Vaccination n=525 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=528 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 16: n=489, 479	6529.4 milli Merck Units/mL Interval 689.0 to 76781.0	6940.6 milli Merck Units/mL Interval 841.0 to 49390.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 11: n=479, 462	1170.3 milli Merck Units/mL Interval 84.0 to 13438.0	1212.6 milli Merck Units/mL Interval 153.0 to 9816.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 6: n=477, 461	1637.9 milli Merck Units/mL Interval 8.0 to 24405.0	1725.0 milli Merck Units/mL Interval 173.0 to 12040.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV18: n=486, 475	1854.1 milli Merck Units/mL Interval 81.0 to 38887.0	1954.8 milli Merck Units/mL Interval 49.0 to 15582.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 31: n=485, 473	1646.2 milli Merck Units/mL Interval 88.0 to 22848.0	1750.6 milli Merck Units/mL Interval 118.0 to 32822.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 33: n=487, 478	823.8 milli Merck Units/mL Interval 54.0 to 6563.0	915.5 milli Merck Units/mL Interval 110.0 to 7058.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 45: n=489, 478	658.2 milli Merck Units/mL Interval 28.0 to 14131.0	675.6 milli Merck Units/mL Interval 29.0 to 8725.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 52: n=490, 479	965.4 milli Merck Units/mL Interval 45.0 to 11730.0	1015.3 milli Merck Units/mL Interval 79.0 to 14392.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 58: n=484, 469	1188.8 milli Merck Units/mL Interval 102.0 to 13681.0	1334.8 milli Merck Units/mL Interval 106.0 to 14752.0

PRIMARY outcome

Timeframe: Day 1 through Day 5 following Day 1 vaccination

Population: The population analyzed included all vaccinated participants with follow-up

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.

Outcome measures

Measure	Concomitant Vaccination n=524 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=527 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Percentage of Participants With a V503 Injection-site Adverse Experience	63.4 Percentage of participants	62.8 Percentage of participants

PRIMARY outcome

Timeframe: Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination

Population: The population analyzed included all vaccinated participants with follow-up

For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received Repevax™ vaccination were reported for this endpoint.

Outcome measures

Measure	Concomitant Vaccination n=525 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=520 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Percentage of Participants With a Repevax™ Injection-site Adverse Experience	88.0 Percentage of participants	84.6 Percentage of participants

PRIMARY outcome

Timeframe: Up to 5 days following the Day 1 and Month 1 vaccination / visit

Population: The population analyzed included all vaccinated participants with follow-up

For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.

Outcome measures

Measure	Concomitant Vaccination n=524 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=525 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)	8.8 Percentage of participants	8.4 Percentage of participants

PRIMARY outcome

Timeframe: Up to 15 days following the Day 1 and Month 1 vaccination / visit

Population: The population analyzed included all vaccinated participants with follow-up

For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site.

Outcome measures

Measure	Concomitant Vaccination n=525 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=527 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Percentage of Participants With a Systemic Adverse Experience	48.6 Percentage of participants	48.6 Percentage of participants

PRIMARY outcome

Timeframe: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination

Population: The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint

For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of >=0.1 IU/mL.

Outcome measures

Measure	Concomitant Vaccination n=525 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=528 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody Anti-diphtheria titer >=0.1 IU/mL: n=505, 474	99.8 Percentage of participants Interval 98.9 to 100.0	99.6 Percentage of participants Interval 98.5 to 99.9
Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody Anti-tetanus titer >=0.1 IU/mL: n=504, 472	99.6 Percentage of participants Interval 98.6 to 100.0	99.6 Percentage of participants Interval 98.5 to 99.9

PRIMARY outcome

Timeframe: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination

Population: The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint

For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL).

Outcome measures

Measure	Concomitant Vaccination n=525 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=528 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Geometric Mean Titers of Pertussis Antibody Responses Anti-PT: n=505, 473	41.5 ELU/mL Interval 38.4 to 44.9	43.8 ELU/mL Interval 40.4 to 47.5
Geometric Mean Titers of Pertussis Antibody Responses Anti-FHA: n=505, 474	188.1 ELU/mL Interval 176.2 to 200.8	190.6 ELU/mL Interval 178.1 to 203.9
Geometric Mean Titers of Pertussis Antibody Responses Anti-PRN: n=505, 474	372.9 ELU/mL Interval 334.8 to 415.2	398.2 ELU/mL Interval 356.3 to 445.0
Geometric Mean Titers of Pertussis Antibody Responses Anti-FIM 2/3: n=505, 474	378.2 ELU/mL Interval 324.4 to 440.9	423.6 ELU/mL Interval 361.5 to 496.2

PRIMARY outcome

Timeframe: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination

Population: The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint

For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at >=1:8 dilution of serum.

Outcome measures

Measure	Concomitant Vaccination n=525 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=528 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody Poliovirus type 1: n=505, 474	99.6 Percentage of participants Interval 98.4 to 100.0	99.8 Percentage of participants Interval 98.7 to 100.0
Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody Poliovirus type 2: n=505, 474	99.6 Percentage of participants Interval 98.4 to 100.0	99.8 Percentage of participants Interval 98.7 to 100.0
Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody Poliovirus type 3: n=505, 474	100 Percentage of participants Interval 99.1 to 100.0	100 Percentage of participants Interval 99.1 to 100.0

SECONDARY outcome

Timeframe: Month 7

Population: The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint

Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8.

Outcome measures

Measure	Concomitant Vaccination n=525 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=528 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Percentage of Participants Who Seroconvert for Each of the HPV Types Anti-HPV 6: n=477, 461	99.8 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Anti-HPV 11: n=479, 462	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Anti-HPV 16: n=489, 479	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Anti-HPV 18: n=486, 475	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Anti-HPV 31: n=485, 473	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Anti-HPV 33: n=487, 478	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Anti-HPV 45: n=489, 478	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Anti-HPV 52: n=490, 479	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Anti-HPV 58: n=484, 469	100.0 Percentage of participants	100.0 Percentage of participants

Adverse Events

Concomitant Vaccination

Serious events: 9 serious events

Other events: 509 other events

Deaths: 0 deaths

Non-concomitant Vaccination

Serious events: 7 serious events

Other events: 505 other events

Deaths: 0 deaths

Serious adverse events

Measure	Concomitant Vaccination n=525 participants at risk V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Day 1	Non-concomitant Vaccination n=527 participants at risk V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
General disorders Non-cardiac chest pain	0.19% 1/525 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.00% 0/527 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Infections and infestations Appendiceal abscess	0.00% 0/525 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.19% 1/527 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Infections and infestations Appendicitis	0.19% 1/525 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.38% 2/527 • Number of events 2 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Infections and infestations Dengue fever	0.19% 1/525 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.00% 0/527 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Infections and infestations Pyelonephritis	0.19% 1/525 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.00% 0/527 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Infections and infestations Pyelonephritis acute	0.00% 0/525 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.19% 1/527 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Infections and infestations Viral pharyngitis	0.19% 1/525 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.00% 0/527 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Injury, poisoning and procedural complications Forearm fracture	0.38% 2/525 • Number of events 2 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.00% 0/527 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Injury, poisoning and procedural complications Road traffic accident	0.19% 1/525 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.00% 0/527 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Injury, poisoning and procedural complications Thermal burn	0.00% 0/525 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.19% 1/527 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Musculoskeletal and connective tissue disorders Fibromyalgia	0.19% 1/525 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.00% 0/527 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Nervous system disorders Syncope	0.00% 0/525 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.19% 1/527 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Psychiatric disorders Eating disorder	0.00% 0/525 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	0.19% 1/527 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™

Other adverse events

Measure	Concomitant Vaccination n=525 participants at risk V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Day 1	Non-concomitant Vaccination n=527 participants at risk V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Gastrointestinal disorders Abdominal pain upper	3.6% 19/525 • Number of events 22 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	5.3% 28/527 • Number of events 28 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Gastrointestinal disorders Nausea	7.4% 39/525 • Number of events 42 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	6.8% 36/527 • Number of events 46 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
General disorders Injection-site erythema	43.4% 228/525 • Number of events 351 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	35.1% 185/527 • Number of events 290 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
General disorders Injection-site pain	95.4% 501/525 • Number of events 1500 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	93.5% 493/527 • Number of events 1463 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
General disorders Injection-site pruritus	5.3% 28/525 • Number of events 31 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	5.1% 27/527 • Number of events 36 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
General disorders Injection-site swelling	56.2% 295/525 • Number of events 528 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	43.6% 230/527 • Number of events 403 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
General disorders Pyrexia	16.8% 88/525 • Number of events 105 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	13.5% 71/527 • Number of events 86 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Infections and infestations Nasopharyngitis	3.4% 18/525 • Number of events 18 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	6.1% 32/527 • Number of events 39 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Infections and infestations Upper respiratory tract infection	4.4% 23/525 • Number of events 24 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	5.1% 27/527 • Number of events 31 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Nervous system disorders Headache	31.8% 167/525 • Number of events 265 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	26.6% 140/527 • Number of events 200 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.4% 23/525 • Number of events 25 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™	5.7% 30/527 • Number of events 32 • Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs Adverse events were collected for all participants who received at least one dose of V503 and Repevax™

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
• Publication restrictions are in place

Restriction type: OTHER