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Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old

NCT01627561 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2020-04-10

Study results available
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Summary

The current study evaluates the immunogenicity and safety in 4-6 years old female subjects (experimental group) receiving Cervarix according to a 2-dose schedule (Month 0, 6), as compared to 4-6 years old female subjects (control group) receiving sequentially Priorix (Month 0) and Infanrix (Month 6) vaccines.

Conditions

  • Infections, Papillomavirus

Interventions

BIOLOGICAL

Cervarix

2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6.

BIOLOGICAL

Priorix

1 dose administered intramuscularly in the deltoid muscle of the left arm at Day 0.

BIOLOGICAL

Infanrix

1 dose administered intramuscularly in the deltoid muscle of the left arm at Month 6.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-15
Primary Completion
2014-04-23
Completion
2016-10-06

Countries

  • Colombia
  • Mexico
  • Panama

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 NCT01627561 on ClinicalTrials.gov