Trial Outcomes & Findings for Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025) (NCT NCT00325130)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1042 participants

Primary outcome timeframe

7 Months

Results posted on

2015-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Concomitant Administration Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Overall Study STARTED	518	524
Overall Study COMPLETED	499	494
Overall Study NOT COMPLETED	19	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Concomitant Administration Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Overall Study Lost to Follow-up	6	14
Overall Study Withdrawal by Subject	12	14
Overall Study Protocol Deviation	0	1
Overall Study Moved	0	1
Overall Study Patient Discontinued for Other	1	0

Baseline Characteristics

Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Concomitant Administration n=518 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=524 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Total n=1042 Participants Total of all reporting groups
Age, Continuous	12.5 years STANDARD_DEVIATION 1.84 • n=5 Participants	12.7 years STANDARD_DEVIATION 1.90 • n=7 Participants	12.6 years STANDARD_DEVIATION 1.88 • n=5 Participants
Age, Customized 9 Years of Age and Under	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized 10 to 17 Years of Age	518 participants n=5 Participants	524 participants n=7 Participants	1042 participants n=5 Participants
Age, Customized Over 17 Years of Age	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Sex: Female, Male Female	308 Participants n=5 Participants	340 Participants n=7 Participants	648 Participants n=5 Participants
Sex: Female, Male Male	210 Participants n=5 Participants	184 Participants n=7 Participants	394 Participants n=5 Participants
Race/Ethnicity Asian	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants
Race/Ethnicity Black	54 participants n=5 Participants	74 participants n=7 Participants	128 participants n=5 Participants
Race/Ethnicity Hispanic American	42 participants n=5 Participants	29 participants n=7 Participants	71 participants n=5 Participants
Race/Ethnicity Indian	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity Multi-Racial	9 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants
Race/Ethnicity Native American	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity White	406 participants n=5 Participants	404 participants n=7 Participants	810 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=418 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=418 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)	416 Participants	417 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=418 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=418 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months)	418 Participants	418 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=421 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=420 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)	421 Participants	420 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=423 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=421 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months)	421 Participants	420 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=424 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=412 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™	367 Participants	345 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=451 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=422 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™	423 Participants	394 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=446 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=415 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™	429 Participants	394 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=439 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=427 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™	414 Participants	404 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=398 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=381 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	397 Participants	381 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=398 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=384 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	398 Participants	384 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=418 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=418 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™	1349.3 mMU/mL Interval 1189.7 to 1530.3	1340.8 mMU/mL Interval 1181.6 to 1521.4

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=418 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=418 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™	1609.6 mMU/mL Interval 1469.9 to 1762.6	1513.7 mMU/mL Interval 1381.8 to 1658.1

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=421 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=420 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™	7203.0 mMU/mL Interval 6448.0 to 8046.4	7370.0 mMU/mL Interval 6593.6 to 8237.9

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=423 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=421 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™	1270.2 mMU/mL Interval 1128.9 to 1429.1	1425.3 mMU/mL Interval 1265.7 to 1605.1

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=425 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=391 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	18.5 ELISA units/mL Interval 16.9 to 20.2	19.3 ELISA units/mL Interval 17.5 to 21.2

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=430 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=402 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	132.5 ELISA units/mL Interval 122.4 to 143.4	150.9 ELISA units/mL Interval 138.9 to 164.0

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=430 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=402 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	253.6 ELISA units/mL Interval 229.8 to 279.9	274.2 ELISA units/mL Interval 274.2 to 304.1

PRIMARY outcome

Timeframe: 7 Months

Population: Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.

Outcome measures

Outcome measures
Measure	Concomitant Administration n=430 Participants Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration n=402 Participants Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	703.0 ELISA units/mL Interval 609.9 to 810.2	611.2 ELISA units/mL Interval 526.4 to 709.6

SECONDARY outcome

Timeframe: 15 days post injection

Outcome measures

Outcome data not reported

Adverse Events

Concomitant Administration

Serious events: 0 serious events

Other events: 475 other events

Deaths: 0 deaths

Non-concomitant Administration

Serious events: 2 serious events

Other events: 448 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Concomitant Administration Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/522	0.20% 1/498
General disorders Parotidectomy	0.00% 0/522	0.20% 1/498

Other adverse events

Other adverse events
Measure	Concomitant Administration Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™	Non-concomitant Administration Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
General disorders Injection Site Pain quadrivalent HPV Vaccine postvaccination 1	61.3% 315/514	56.2% 228/406
General disorders Injection Site Swelling HPV Vaccine postvaccination 1	10.9% 56/514	6.9% 28/406
General disorders Injection Site Erythema qHPV Vaccine (postvaccination 2)	10.5% 53/506	12.4% 61/492
General disorders Injection Site Pain qHPV Vaccine (postvaccination 2)	41.5% 210/506	39.4% 194/492
General disorders Injection Site Erythema qHPV Vaccine (postvaccination 3)	13.5% 68/503	12.4% 60/485
General disorders Injection Site Pain qHPV Vaccine (postvaccination 3)	50.3% 253/503	48.2% 234/485
General disorders Injection Site Swelling qHPV Vaccine (postvaccination 3)	10.3% 52/503	11.3% 55/485
General disorders Injection Site Erythema ADACEL™ + Menactra™	23.5% 121/514	26.7% 107/401
General disorders Injection Site Pain ADACEL™ + Menactra™	81.9% 421/514	75.6% 303/401
General disorders Injection Site Swelling ADACEL™ + Menactra™	28.2% 145/514	28.2% 113/401
Nervous system disorders Headache Systemic Clinical	21.7% 113/520	22.9% 114/498
General disorders Injection Site Erythema qHPV Vaccine (post-vaccination 1)	7.2% 37/514	6.4% 26/406
General disorders Injection Site Swelling qHPV Vaccine (post-vaccination 2)	8.3% 42/506	9.8% 48/492
General disorders Injection Site Bruising ADACEL™ + Menactra™	5.8% 30/514	2.2% 9/401
Gastrointestinal disorders Abdominal Pain Upper	5.2% 27/520	5.2% 26/498
General disorders Pyrexia	8.7% 45/520	10.0% 50/498
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	5.0% 26/520	7.0% 35/498

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER