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)
Phase 3
11 Years
15 Years
11 Years
15 Years
Not Enrolling
Both
Human Papillomavirus Infection
Both
Human Papillomavirus Infection
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the HPV Types Contained in V503
Outcome Time Frame:
4 Weeks Postdose 3 of V503
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2009_670
NCT ID:
NCT00988884
Start Date:
October 2009
Completion Date:
February 2011
Related Keywords:
- Human Papillomavirus Infection
- Warts
- Papillomavirus Infections
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