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
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 45
Healthy Volunteers: t
View:

• Participants aged 9-45;

• Participants aged 18-45 who can provide legal identification,participants aged 9-17 and their guardian can provide legal identification;

• Participants and/or their guardian sign an informed consent form;

• Axillary temperature less than 37.3 ℃(\>14 years old)or less than 37.5℃(≤14 years old)at the time of enrollment;

• Be able to comply with study protocol requirements;

• Women with reproductive age take effective contraceptive measures within 2 weeks before enrollment in the study, and were not pregnant at the time of enrollment (negative blood pregnancy test), did not have lactation period, and had no birth plan within the 30 days after receiving the whole vaccination;

• Agree to take effective contraceptive measures within 30 days after receiving the whole vaccination (effective contraceptives include: oral contraceptives, injection or embedding contraceptives, sustained release topical contraceptives, hormone patches, intrauterine devices), sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.

Locations
Other Locations
China
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
RECRUITING
Nanning
Contact Information
Primary
Dabin Liang
gxirb2018@163.com
+86 15977783657
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2026-01-13
Participants
Target number of participants: 330
Treatments
Experimental: Medium dose for 15-HPV vaccine
Participants 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
Experimental: High dose for 15-HPV vaccine
Participants 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
Placebo_comparator: Placebo
Participants 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
Active_comparator: 9-HPV-vaccine
Participants aged 18-45 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
Sponsors
Leads: Shanghai Bovax Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov