Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06756269

To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years

A Randomised, Double-blind, Placebo and Positive Controlled, Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity of 15-valent Human Papillomavirus Recombinant Vaccine (Hansenulapolymorpha) in Healthy Chinese People Aged 9-45 Years

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
330 (estimated)
Sponsor
Shanghai Bovax Biotechnology Co., Ltd. · Industry
Sex
All
Age
9 Years – 45 Years
Healthy volunteers
Accepted

Summary

To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.

Detailed description

A Randomized, double-blind, placebo and positive controlled trial is planned in 330 healthy participants across two age groups (18-45 years and 9-17 years) to evaluate the safety and immunogenicity of the 15-valent HPV vaccine.

Conditions

Interventions

TypeNameDescription
BIOLOGICALMedium dose for 15-HPV vaccineParticipants aged 9-45 years were given 3 doses of medium dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
BIOLOGICALHigh dose for 15-HPV vaccineParticipants aged 9-45 years were given 3 doses of high dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
BIOLOGICALPlaceboParticipants aged 9-45 years were given 3 doses of placebo intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
BIOLOGICAL9-HPV vaccineParticipants aged 9-45 years were given 3 doses of 9-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

Timeline

Start date
2025-01-15
Primary completion
2025-10-30
Completion
2026-01-13
First posted
2025-01-01
Last updated
2025-12-17

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06756269. Inclusion in this directory is not an endorsement.