Clinical trial · Interventional
A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) Given Concomitantly With Menactra™ and Adacel™ in Preadolescents and Adolescents (11 to 15 Year Olds)
NCT00988884CI-TRIAL-00036146completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study will evaluate the tolerability and immunogenicity of administration of the first dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one month prior to administration of Menactra™ and Adacel™.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: Adacel™ (Concomitant) | Biological | — | UNRESOLVED |
| Comparator: Adacel™ (Non-concomitant) | Biological | — | UNRESOLVED |
| Comparator: Menactra™ (Concomitant) | Biological | — | UNRESOLVED |
| Comparator: Menactra™ (Non-Concomitant) | Biological | — | UNRESOLVED |
| V503 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Concomitant Vaccination
- description
- V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
- interventionNames
- Biological: V503
- Biological: Comparator: Menactra™ (Concomitant)
- Biological: Comparator: Adacel™ (Concomitant)
- type
- EXPERIMENTAL
- label
- Non-concomitant Vaccination
- description
- V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
- interventionNames
- Biological: V503
- Biological: Comparator: Menactra™ (Non-Concomitant)
- Biological: Comparator: Adacel™ (Non-concomitant)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 11 Years
- Maximum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is in good health * Subject's parent/legal guardian can read, understand, and complete the vaccine report card * Subject is not sexually active and does not plan on becoming sexually active during the study * Subject has received a documented full primary immunization series against diphtheria, tetanus, and pertussis (not in the last 5 years) Exclusion Criteria: * Subject has a known allergy to any vaccine component of V503, Menactra™, or Adacel™ * Subject has a condition that is a contraindication to vaccination with Menactra™ or Adacel™ * Subject has any coagulation disorder * Female subject is pregnant * Subject is immunocompromised or immunodeficient * Subject has had a splenectomy * Subject has received immunosuppressive therapies in the prior year * Subject has received any immune globulin product or blood-derived product in the last 3 months * Subject has received inactivated vaccines within 14 days or live vaccines within 21 days of the first study vaccination * Subject has received a marketed HPV vaccine or has participation in an HPV vaccine trial * Subject has received a meningococcal vaccine * Subject has a fever \>= 100F within 24 hours of vaccination * Subject has a history of HPV
References
Publications (3)
- RESULTRodrigues S, Grenha A. Activation of Macrophages: Establishing a Role for Polysaccharides in Drug Delivery Strategies Envisaging Antibacterial Therapy. Curr Pharm Des. 2015;21(33):4869-87. doi: 10.2174/1381612821666150820103910. PMID 26290207
- RESULTSchilling A, Parra MM, Gutierrez M, Restrepo J, Ucros S, Herrera T, Engel E, Huicho L, Shew M, Maansson R, Caldwell N, Luxembourg A, Ter Meulen AS. Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines. Pediatrics. 2015 Sep;136(3):e563-72. doi: 10.1542/peds.2014-4199. Epub 2015 Aug 3. PMID 26240207
- RESULTMoreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15. PMID 27422279