Trial Outcomes & Findings for A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005) (NCT NCT00988884)

NCT ID: NCT00988884

Last Updated: 2018-12-14

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1241 participants
• Primary outcome timeframe: 4 weeks following Month 6 vaccination
• Results posted on: 2018-12-14

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 Menactra™ and Adacel™ each 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 at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Overall Study STARTED	621	620
Overall Study COMPLETED	586	584
Overall Study NOT COMPLETED	35	36

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 Menactra™ and Adacel™ each 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 at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	20	16
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	15	18

Baseline Characteristics

A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)

Baseline characteristics by cohort

Measure	Concomitant Vaccination n=621 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=620 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	Total n=1241 Participants Total of all reporting groups
Age, Continuous	12.2 Years STANDARD_DEVIATION 1.4 • n=5 Participants	12.1 Years STANDARD_DEVIATION 1.3 • n=7 Participants	12.2 Years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	311 Participants n=5 Participants	310 Participants n=7 Participants	621 Participants n=5 Participants
Sex: Female, Male Male	310 Participants n=5 Participants	310 Participants n=7 Participants	620 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 to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were evaluated using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.

Outcome measures

Measure	Non-concomitant Vaccination n=618 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	Concomitant Vaccination n=619 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 6: n=501, 514	2260.7 milli Merck Units/mL Interval 210.0 to 30594.0	2198.7 milli Merck Units/mL Interval 137.0 to 18555.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 11: n=502, 514	1547.2 milli Merck Units/mL Interval 109.0 to 30345.0	1495.0 milli Merck Units/mL Interval 64.0 to 13292.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 16: n=513, 530	9027.6 milli Merck Units/mL Interval 619.0 to 125497.0	8882.6 milli Merck Units/mL Interval 159.0 to 60653.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 18: n=516, 535	2633.9 milli Merck Units/mL Interval 79.0 to 45639.0	2610.4 milli Merck Units/mL Interval 35.0 to 49077.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 31: n=514, 536	2334.3 milli Merck Units/mL Interval 89.0 to 45636.0	2439.4 milli Merck Units/mL Interval 50.0 to 43734.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 33: n=520, 537	1276.3 milli Merck Units/mL Interval 52.0 to 21991.0	1268.5 milli Merck Units/mL Interval 25.0 to 34514.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 45: n=523, 539	863.8 milli Merck Units/mL Interval 16.0 to 13822.0	947.8 milli Merck Units/mL Interval 8.0 to 15268.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 52: n=521, 538	1103.7 milli Merck Units/mL Interval 50.0 to 20926.0	1082.7 milli Merck Units/mL Interval 26.0 to 10420.0
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 Anti-HPV 58: n=519, 537	1555.1 milli Merck Units/mL Interval 46.0 to 32108.0	1532.8 milli Merck Units/mL Interval 32.0 to 14833.0

PRIMARY outcome

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

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

For the Concomitant Vaccination group, serum samples were collected at Day 1 (baseline) and 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected at Month 1 (baseline) and 4 weeks after the Month 1 vaccination. Bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The serum bactericidal titer is reported as the reciprocal of the final serum dilution giving >50% killing in 60 minutes.

Outcome measures

Measure	Non-concomitant Vaccination n=618 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	Concomitant Vaccination n=619 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups Serogroup C:n=590, 566	95.1 Percentage of participants	92.9 Percentage of participants
Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups Serogroup Y: n=590, 566	89.4 Percentage of participants	91.5 Percentage of participants
Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups Serogroup W-135: n=589, 566	97.7 Percentage of participants	95.6 Percentage of participants
Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups Serogroup A: n=590, 564	75.4 Percentage of participants	79.0 Percentage of participants

PRIMARY outcome

Timeframe: 4 weeks following Day 1 or Month 1 vaccination

Population: The per-protocol population included participants who received study 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. The lower limit of quantitation of the assay was defined as 0.01 International Units (IU)/mL. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limit of quantitation of the assay was defined as 0.04 IU/mL. Acceptable titers refer to the World Health Organization-defined protective titers of >=0.1 IU/mL.

Outcome measures

Measure	Non-concomitant Vaccination n=618 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	Concomitant Vaccination n=619 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody Anti-diphtheria titer >=0.1 IU/mL: n=595, 566	100 Percentage of participants	100 Percentage of participants
Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody Anti-tetanus titer >=0.1 IU/mL: n=594, 562	100 Percentage of participants	99.8 Percentage of participants

PRIMARY outcome

Timeframe: 4 weeks following Day 1 or Month 1 vaccination

Population: The per-protocol population included participants who received study 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. The titers were expressed as Enzyme-linked Immunoassay Units (ELU)/mL.

Outcome measures

Measure	Non-concomitant Vaccination n=618 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	Concomitant Vaccination n=619 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Geometric Mean Titers of Pertussis Antibody Responses Anti-PT: n=595, 566	35.7 ELU/mL Interval 2.5 to 618.0	28.5 ELU/mL Interval 2.5 to 1056.0
Geometric Mean Titers of Pertussis Antibody Responses Anti-FHA: n=595, 566	201.4 ELU/mL Interval 3.0 to 1547.0	184.1 ELU/mL Interval 5.0 to 3019.0
Geometric Mean Titers of Pertussis Antibody Responses Anti-PRN: n=595, 566	344.0 ELU/mL Interval 19.0 to 3232.0	328.4 ELU/mL Interval 15.0 to 5093.0
Geometric Mean Titers of Pertussis Antibody Responses Anti-FIM 2/3: n=595, 566	681.4 ELU/mL Interval 2.5 to 27520.0	653.0 ELU/mL Interval 2.5 to 73900.0

PRIMARY outcome

Timeframe: Day 1 through Day 5 following Day 1 vaccination

Population: The population analyzed included all vaccinated participants with follow-up for injection-site AEs

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 study vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.

Outcome measures

Measure	Non-concomitant Vaccination n=609 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	Concomitant Vaccination n=611 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Percentage of Participants With a V503 Injection-site Adverse Experience	58.0 Percentage of participants	59.9 Percentage of participants

PRIMARY outcome

Timeframe: Day 1 through Day 5 following Day 1 or Month 1 vaccination

Population: The population analyzed included all vaccinated participants with follow-up for injection-site AEs

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 study vaccine is also an AE. Only injection-site AEs in the arm that received Menactra™ and Adacel™ vaccination were reported for this endpoint. 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.

Outcome measures

Measure	Non-concomitant Vaccination n=598 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	Concomitant Vaccination n=611 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience	70.7 Percentage of participants	74.6 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	Non-concomitant Vaccination n=606 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	Concomitant Vaccination n=610 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)	8.1 Percentage of participants	7.7 Percentage of participants

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	Non-concomitant Vaccination n=618 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	Concomitant Vaccination n=619 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 Anti-HPV 6: n=501, 514	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 Anti-HPV 11: n=502, 514	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 Anti-HPV 16: n=513, 530	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 Anti-HPV 18: n=516, 535	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 Anti-HPV 31: n=514, 536	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 Anti-HPV 33: n=520, 537	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 Anti-HPV 45: n=523, 539	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 Anti-HPV 52: n=521, 538	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 Anti-HPV 58: n=519, 537	100.0 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: 4 weeks following Day 1 or Month 1 vaccination

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

Serum bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The antibody titer is expressed as the reciprocal of the highest dilution that achieves >50% bacterial killing; a higher value represents a greater antibody response. For the Concomitant Vaccination group, serum samples were collected 4 weeks after Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after Month 1 vaccination.

Outcome measures

Measure	Non-concomitant Vaccination n=618 Participants V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	Concomitant Vaccination n=619 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™ Serogroup W-135: n=595, 567	3794.9 Titer Interval 3286.2 to 4382.2	3998.4 Titer Interval 3474.4 to 4601.5
Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™ Serogroup A: n=595, 567	4365.6 Titer Interval 4057.9 to 4696.6	4832.7 Titer Interval 4499.9 to 5190.0
Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™ Serogroup C: n=595, 567	1068.4 Titer Interval 914.5 to 1248.1	1002.8 Titer Interval 861.7 to 1167.2
Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™ Serogroup Y: n=595, 567	1066.7 Titer Interval 923.6 to 1231.9	1416.2 Titer Interval 1230.5 to 1629.9

Adverse Events

Concomitant Vaccination

Serious events: 5 serious events

Other events: 543 other events

Deaths: 0 deaths

Non-concomitant Vaccination

Serious events: 5 serious events

Other events: 518 other events

Deaths: 0 deaths

Serious adverse events

Measure	Concomitant Vaccination n=613 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=611 participants at risk V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Infections and infestations Appendicitis	0.33% 2/613 • Number of events 2 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	0.16% 1/611 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
Infections and infestations Bronchitis	0.00% 0/613 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	0.16% 1/611 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
Infections and infestations Dengue fever	0.00% 0/613 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	0.16% 1/611 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
Infections and infestations Gastroenteritis	0.00% 0/613 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	0.16% 1/611 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
Injury, poisoning and procedural complications Seroma	0.16% 1/613 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	0.00% 0/611 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
Psychiatric disorders Affective disorder	0.16% 1/613 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	0.00% 0/611 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
Psychiatric disorders Depression	0.00% 0/613 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	0.16% 1/611 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
Reproductive system and breast disorders Testicular torsion	0.16% 1/613 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	0.00% 0/611 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
Vascular disorders Orthostatic hypotension	0.00% 0/613 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	0.16% 1/611 • Number of events 1 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™

Other adverse events

Measure	Concomitant Vaccination n=613 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1	Non-concomitant Vaccination n=611 participants at risk V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
General disorders Injection-site erythema	40.0% 245/613 • Number of events 385 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	38.1% 233/611 • Number of events 357 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
General disorders Injection-site pain	84.5% 518/613 • Number of events 1373 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	80.2% 490/611 • Number of events 1298 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
General disorders Injection-site swelling	45.0% 276/613 • Number of events 492 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	41.7% 255/611 • Number of events 414 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
General disorders Pyrexia	14.4% 88/613 • Number of events 111 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	15.5% 95/611 • Number of events 113 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
Infections and infestations Nasopharyngitis	5.2% 32/613 • Number of events 36 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	4.4% 27/611 • Number of events 30 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
Nervous system disorders Headache	22.8% 140/613 • Number of events 193 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	17.5% 107/611 • Number of events 157 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.2% 32/613 • Number of events 34 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™	4.3% 26/611 • Number of events 27 • Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™

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