Phase 3
N=1,241
A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
Human Papillomavirus Infection
Bottom Line
View on ClinicalTrials.gov: NCT00988884 ↗Enrolled (actual)
1,241
Serious AEs
0.8%
Results posted
Jan 2015
Primary outcome: Primary: Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 — 2198.7; 2260.7; 1495.0; 1547.2 milli Merck Units/mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V503 (Biological); Comparator: Menactra™ (Concomitant) (Biological); Comparator: Adacel™ (Concomitant) (Biological); Comparator: Menactra™ (Non-Concomitant) (Biological); Comparator: Adacel™ (Non-concomitant) (Biological)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 |
2198.7; 2260.7; 1495.0; 1547.2; 8882.6; 9027.6 | <0.001 sig |
| PRIMARY Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups |
79.0; 75.4; 92.9; 95.1; 91.5; 89.4 | <0.001 sig |
| PRIMARY Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody |
100; 100; 99.8; 100 | <0.001 sig |
| PRIMARY Geometric Mean Titers of Pertussis Antibody Responses |
28.5; 35.7; 184.1; 201.4; 328.4; 344.0 | 0.003 sig |
| PRIMARY Percentage of Participants With a V503 Injection-site Adverse Experience |
59.9; 58.0 | — |
| PRIMARY Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience |
74.6; 70.7 | — |
| PRIMARY Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent) |
7.7; 8.1 | 0.806 |
| SECONDARY Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™ |
4832.7; 4365.6; 1002.8; 1068.4; 1416.2; 1066.7 | — |
Summary
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™.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00988884). 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.