Phase 3 N=843 Randomized Prevention

Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)

Neoplasms, Glandular and Epithelial · Diphtheria · Tetanus · Whooping Cough · Poliomyelitis

Bottom Line

View on ClinicalTrials.gov: NCT00337428 ↗

Enrolled (actual)

843

Serious AEs

0.5%

Results posted

Feb 2010

Primary outcome: Primary: Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3) — 1151.3; 1244.9 milliMerck units/mL — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF) (Biological); Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF) (Biological); Comparator: REPEVAX™ (Concomitant) (Biological); Comparator: REPEVAX™ (Non-Concomitant) (Biological)
Age: Pediatric · 11+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: May 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)	1151.3; 1244.9	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3)	1338.3; 1460.7	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3)	5835.7; 6508.1	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3)	1096.0; 1308.8	<0.001 sig
PRIMARY Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)	367; 375	<0.001 sig
PRIMARY Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3)	367; 376	<0.001 sig
PRIMARY Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)	370; 378	<0.001 sig
PRIMARY Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3)	372; 378	<0.001 sig
PRIMARY Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™	380; 379	<0.001 sig
PRIMARY Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™	381; 380	<0.001 sig
PRIMARY Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™	367; 376	<0.001 sig
PRIMARY Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™	369; 376	<0.001 sig
PRIMARY Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™	360; 375	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™	38.1; 35.7	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™	140.3; 140.7	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™	504.1; 552.8	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™	561.2; 506.4	<0.001 sig

Summary

Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.

Eligibility Criteria

Inclusion Criteria

Must be healthy boys or girls, 11-17 years of age
Must be a virgin with no intention of becoming sexually active during the study period
Must have been properly vaccinated against diphtheria, tetanus, pertussis and polio

Exclusion Criteria

Must not have received a vaccine against diphtheria, tetanus, pertussis and polio in the past 5 years
Must not have received any prior human papillomavirus (HPV) vaccine

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00337428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.