NCT03629886

Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6,051 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 26 Years
• Healthy volunteers: Accepted

Summary

This study was designed to enable all subjects who received placebo in the HPV-039 study (NCT00779766), to also receive GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed. Safety data in terms of serious adverse events (SAEs), any adverse events (AEs)/SAEs leading to premature discontinuation of the study, potential immune mediated diseases (pIMDs) and pregnancies (and their outcomes) were collected during the study period. In addition, this study assessed the long term protective effect of the vaccine, in an exploratory manner, in terms of rates of HPV-related (vaccine type) incident cervical infection up to approximately 10 years after vaccination in subjects who participated in HPV-039 study (NCT00779766).

Detailed description

Treatment allocation depended on the randomization in the previous study i.e. only the subjects from the control group of HPV-039 study received HPV vaccination in the current study. Subjects who previously received the Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed in HPV-039 study did not receive vaccination in this study.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
BIOLOGICAL	HPV (Types 16, 18) Vaccine, Adsorbed	Three doses of Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed administered intramuscularly in the deltoid region of the upper arm, according to a 0, 1, 6-month schedule.

Timeline

• Start date: 2018-08-22
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2018-08-14
• Last updated: 2024-03-15
• Results posted: 2020-12-19

Locations

4 sites across 1 country: China