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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-03

Study Completion Date

2008-02-04

Brief Summary

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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 is composed of L1 virus-like particles (VLPs) from HPV types 6, 11, 16, and 18.

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Detailed Description

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Conditions

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Papillomavirus Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)

Participants who enroll receive a total of 3 intramuscular injections of Quadrivalent HPV VLP vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.

Group Type EXPERIMENTAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Intervention Type BIOLOGICAL

Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.

Interventions

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Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes