NCT00250276

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

Assess Lot-to-lot Consistency of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Following Manufacturing Adjustments Administered Intramuscularly According to a 0,1,6-mth Schedule in Healthy Female Subjects (18-25 y)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 798 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	Cervarix™	GSK Biologicals' vaccine against human papillomaviruses 16 and 18.

Timeline

• Start date: 2005-10-28
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2005-11-08
• Last updated: 2020-01-02
• Results posted: 2017-03-17

Locations

8 sites across 3 countries: Denmark, Lithuania, Poland