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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

NCT05496231 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1080

Last updated 2025-02-03

Study results available
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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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
26 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2024-02-23
Completion
2024-02-25
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Estonia
  • France
  • Germany
  • Lithuania
  • Poland

Study Locations

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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 NCT05496231 on ClinicalTrials.gov