Clinical trial · Interventional
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)
An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V501 Given Concomitantly With Menactra™ and ADACEL™ 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 V501 (Human Papillomavirus (HPV) \[Types 6, 11, 16, 18\] Recombinant Vaccine) , when administered concomitantly with a combined diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate 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 | — |
| Meningitis | — | UNRESOLVED | — |
| Neoplasms, Glandular and Epithelial | Neoplasm | ONTOLOGY_EXACT | 0.85 |
| Tetanus | — | UNRESOLVED | — |
| Whooping Cough | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: Adacel™ | Biological | — | UNRESOLVED |
| Comparator: Adacel™ (Concomitant) | Biological | — | UNRESOLVED |
| Comparator: Menactra™ (Concomitant) | Biological | — | UNRESOLVED |
| Comparator: Menactra™ (Non-concomitant) | Biological | — | UNRESOLVED |
| Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Concomitant Administration
- interventionNames
- Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine
- Biological: Comparator: Menactra™ (Concomitant)
- Biological: Comparator: Adacel™ (Concomitant)
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Non-concomitant administration
- interventionNames
- Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine
- Biological: Comparator: Menactra™ (Non-concomitant)
- Biological: Comparator: Adacel™
Primary outcomes (18)
- measure
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 and pertussis Exclusion Criteria: * Must not have received a vaccine against diphtheria, tetanus and pertussis in the past 5 years * Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal vaccine
References
Publications (1)
- RESULTReisinger KS, Block SL, Collins-Ogle M, Marchant C, Catlett M, Radley D, Sings HL, Haupt RM, Garner EI; Protocol 025 Investigators. Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel. Pediatrics. 2010 Jun;125(6):1142-51. doi: 10.1542/peds.2009-2336. Epub 2010 May 3. PMID 20439595