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Human Papillomavirus Vaccine Safety & Immunogenicity Trial in Healthy Young Adult Women With HPV Vaccine (GSK1674330A)

NCT00478621 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2017-05-10

No results posted yet for this study

Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals' HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control vaccine. There will be different levels of blinding in the study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Infections, Papillomavirus

Interventions

BIOLOGICAL

GSK Biologicals' HPV vaccine (GSK1674330A)

Intramuscular administration, 5 different formulations

BIOLOGICAL

Cervarix TM

Intramuscular administration

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-25
Primary Completion
2008-06-30
Completion
2008-10-13

Countries

  • Belgium

Study Locations

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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 NCT00478621 on ClinicalTrials.gov