Clinical trial · Interventional
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)
An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Gardasil (V501) Given Concomitantly With REPEVAX™ in Healthy Adolescents 11-17 Years of Age
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diphtheria | — | UNRESOLVED | — |
| Neoplasms, Glandular and Epithelial | Neoplasm | ONTOLOGY_EXACT | 0.85 |
| Poliomyelitis | — | UNRESOLVED | — |
| Tetanus | — | UNRESOLVED | — |
| Whooping Cough | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF) | Biological | — | UNRESOLVED |
| Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF) | Biological | — | UNRESOLVED |
| Comparator: REPEVAX™ (Concomitant) | Biological | — | UNRESOLVED |
| Comparator: REPEVAX™ (Non-Concomitant) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Concomitant/CMF
- interventionNames
- Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
- Biological: Comparator: REPEVAX™ (Concomitant)
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Non-Concomitant/CMF
- interventionNames
- Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
- Biological: Comparator: REPEVAX™ (Non-Concomitant)
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 11 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTVesikari T, Van Damme P, Lindblad N, Pfletschinger U, Radley D, Ryan D, Vuocolo S, Haupt RM, Guris D. An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) vaccine given concomitantly with diphtheria, tetanus, pertussis, and poliomyelitis vaccine in healthy adolescents 11 to 17 years of age. Pediatr Infect Dis J. 2010 Apr;29(4):314-8. doi: 10.1097/INF.0b013e3181c177fb. PMID 19952980