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Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

NCT00250276 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 798

Last updated 2020-01-02

Study results available
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Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.

Conditions

  • Infections, Papillomavirus
  • Papillomavirus Vaccines

Interventions

BIOLOGICAL

Cervarix™

GSK Biologicals' vaccine against human papillomaviruses 16 and 18.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-10-28
Primary Completion
2007-03-01
Completion
2007-03-01

Countries

  • Denmark
  • Lithuania
  • Poland

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 NCT00250276 on ClinicalTrials.gov