Trials / Completed
CompletedNCT00325130
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,042 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 11 Years – 17 Years
- Healthy volunteers
- Accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine | Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6. |
| BIOLOGICAL | Comparator: Menactra™ (Concomitant) | A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1 |
| BIOLOGICAL | Comparator: Adacel™ (Concomitant) | a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1 |
| BIOLOGICAL | Comparator: Menactra™ (Non-concomitant) | A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1 |
| BIOLOGICAL | Comparator: Adacel™ | A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1 |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2007-04-01
- Completion
- 2007-04-01
- First posted
- 2006-05-12
- Last updated
- 2015-03-12
- Results posted
- 2009-07-13
Source: ClinicalTrials.gov record NCT00325130. Inclusion in this directory is not an endorsement.