Status:
COMPLETED
A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Human Papillomavirus Infection
Eligibility:
All Genders
11-15 years
Phase:
PHASE3
Brief 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 admi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2011
Estimated Enrollment :
1241 Patients enrolled
Trial Details
Trial ID
NCT00988884
Start Date
October 21 2009
End Date
February 22 2011
Last Update
December 14 2018
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