Status:

COMPLETED

Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Papillomavirus Infections

Eligibility:

FEMALE

9-15 years

Phase:

PHASE3

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India. Quadrivalent HPV Vaccine ...

Eligibility Criteria

Inclusion

  • Healthy Females Age 9 To 15 Years
  • Females Not Sexually Active And Not Plan On Becoming Sexually Active During The Study
  • No Fevers 24 Hours Prior To The First Injection

Exclusion

  • Participant Had Received A Prior Vaccination With A HPV Vaccine
  • Participant Has Allergies To Vaccine Component Including Aluminum And Yeast
  • Participant Has (Human Immunodeficiency Virus) HIV Infection
  • Participant Is Immunocompromised
  • Participant Received Or Plans To Receive Blood-Derived Product Within 6 Months Prior To The First Injection
  • Participant Received Or Plans To Receive Immune Globulin Preparation Within 6 Months To The First Injection

Key Trial Info

Start Date :

May 3 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 4 2008

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT00380367

Start Date

May 3 2007

End Date

February 4 2008

Last Update

May 31 2023

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Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029) | DecenTrialz