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Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

NCT00578227 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 814

Last updated 2018-08-17

Study results available
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Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.

Conditions

  • Infections, Papillomavirus

Interventions

BIOLOGICAL

Cervarix™

Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

BIOLOGICAL

Twinrix ™ Paediatric

Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-12-15
Primary Completion
2008-12-01
Completion
2009-04-28

Countries

  • Canada
  • Denmark
  • Hungary
  • Sweden

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 NCT00578227 on ClinicalTrials.gov