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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus Vaccine (Cervarix™) When Co-administered With GSK Biologicals' Hepatitis A Vaccine (Havrix®) in Healthy Female Adolescents Aged 9-14 Years

NCT02082639 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-07-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the immunogenicity and safety of two doses of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine when co-administered with GSK Biologicals' HAV vaccine according to 0, 6 month schedule, compared to the administration of either of these vaccines alone. The study will ascertain that the immune responses elicited to the two vaccines are not adversely impacted compared to when HPV-16/18 L1 VLP AS04 vaccine and HAV vaccine are administered alone.

Conditions

  • Infections, Papillomavirus

Interventions

BIOLOGICAL

Cervarix™

2 doses intramuscularly in the deltoid muscle of the non-dominant arm

BIOLOGICAL

Havrix

2 doses intramuscularly in the deltoid muscle of the dominant arm

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
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-08-31
Completion
2015-11-30

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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 NCT02082639 on ClinicalTrials.gov