Phase 3
Completed N=843
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
Source: ClinicalTrials.gov NCT00337428 ↗
Enrolled (actual)
843
Serious AEs
0.5%
Results posted
Feb 2010
Primary outcomePrimary: 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
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.
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 |
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
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. Informational only — not medical advice.