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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