NCT00549900

A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females

Safety and Immunogenicity Study of the HPV Vaccine (GSK-580299) in Healthy, Chinese, Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A phase I, open label, single-centre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM), administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female subjects aged 15 - 45 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

The rationale for the protocol posting amendment was to change the study population from 18-35 to 15-45 years and to allow subjects who were administered routine vaccines e.g. Hepatitis A\&B vaccines, meningococcal vaccines, Tetanus vaccine, Diphteria Tetanus Pertussis etc. up to 8 days before each HPV dose.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)	Intramuscular injection, 3 doses

Timeline

• Start date: 2007-12-02
• Primary completion: 2008-07-12
• Completion: 2008-07-12
• First posted: 2007-10-26
• Last updated: 2018-07-20
• Results posted: 2009-12-17

Locations

1 site across 1 country: China