NCT06207175

A Study to Evaluate the Immunogenicity and Safety of Nonavalent Human Papillomavirus (HPV) Vaccine

A Phase III Trial in Healthy Indonesian Women Ages 18-45 to Evaluate the Immunogenicity and Safety of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,260 (actual)
• Sponsor: Beijing Health Guard Biotechnology, Inc · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This Study to Evaluate the Immunogenicity and Safety of Candidate Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) Administered Intramuscularly in Healthy Female Participants Aged 18 to 45 Years

Detailed description

This is a randomized, observer blinded, active controlled, multicenter clinical study. A total of approximately 1,260 healthy female participants aged 18 to 45 years old who meet eligibility will be enrolled, and be randomly assigned into 2 groups in a 1:1 ratio. Immunogenicity: Blood samples (5.0 mL each time) will be collected for all participants prior to the 1st dose of vaccination and on 1, 6, 12, 18 months after full vaccination for anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies and Immunoglobulin G antibodies testing. Safety evaluation (for all participants):To assess solicited (local and systemic) Adverse Event (AEs) within 7 days after each dose of vaccination, unsolicited Adverse Event (AEs) within 30 days after each dose of vaccination, and Serious Adverse Event (SAEs) from 1st dose to 18 months after full vaccination. Collection of pregnancy events:To assess the occurrence of pregnancy events in all participants from 1st dose to 18 months after full vaccination. The subject will be followed to determine the outcome of the pregnancy. At the end of the pregnancy, be it a full-term or premature birth, information on the status of the newborn(s) will be followed up during the first 12 months of life.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Nonavalent HPV study vaccine	A 3-dose regimen administered at months 0, 2 and 6.
BIOLOGICAL	GARDASIL® 9	A 3-dose regimen administered at months 0, 2 and 6.

Timeline

• Start date: 2023-11-21
• Primary completion: 2024-11-17
• Completion: 2026-01-25
• First posted: 2024-01-16
• Last updated: 2024-01-23

Locations

1 site across 1 country: Indonesia