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A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.

NCT00730847 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 743

Last updated 2019-11-05

Study results available
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Summary

The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals' Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per the Bureau of Food and Drugs Directive of Philippines.

Conditions

  • Human Papillomavirus Infection Leading to Cervical Cancer

Interventions

BIOLOGICAL

Cervarix

Three doses of Cervarix administered intramuscularly in the deltoid region, according to a 0, 1, 6-month vaccination schedule.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-17
Primary Completion
2012-01-16
Completion
2012-01-16

Countries

  • Philippines

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00730847 on ClinicalTrials.gov