A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)

Phase

Condition

Gynecological Infections

Human Papilloma Virus (Hpv)

Treatment

N/A

Clinical Study ID

NCT00988884

V503-005

Ages 11-15
All Genders
Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

Subject is in good health
Subject's parent/legal guardian can read, understand, and complete the vaccine reportcard
Subject is not sexually active and does not plan on becoming sexually active duringthe study
Subject has received a documented full primary immunization series against diphtheria,tetanus, and pertussis (not in the last 5 years)

Exclusion

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™ orAdacel™
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 21days of the first study vaccination
Subject has received a marketed HPV vaccine or has participation in an HPV vaccinetrial
Subject has received a meningococcal vaccine
Subject has a fever >= 100F within 24 hours of vaccination
Subject has a history of HPV

Study Design

October 21, 2009

February 22, 2011