NCT05496231

A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age

A Phase 1/2 Randomized, Observer-blinded, Multi-country Study to Evaluate Safety and Immunogenicity of Investigational Adjuvanted Human Papillomavirus Vaccine in Females (16 to 26 Years of Age)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,080 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 16 Years – 26 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study was to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)'s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
BIOLOGICAL	HPV9 High formulation	3 doses of the high formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
BIOLOGICAL	HPV9 Medium formulation	3 doses of the medium formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
BIOLOGICAL	HPV9 Low formulation	3 doses of the low formulation of HPV9 investigational adjuvanted vaccine were administered intramuscularly at Day 1, Month 2 and Month 6.
BIOLOGICAL	Gardasil 9	3 doses of the marketed HPV vaccine (Gardasil 9) were administered intramuscularly at Day 1, Month 2 and Month 6.

Timeline

• Start date: 2022-08-22
• Primary completion: 2024-02-23
• Completion: 2024-02-25
• First posted: 2022-08-11
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

68 sites across 8 countries: United States, Bulgaria, Czechia, Estonia, France, Germany, Lithuania, Poland

Regulatory

• FDA-regulated drug study