A Phase 2 interventional study of Medium dose for 15-HPV vaccine and High dose for 15-HPV vaccine in HPV Infection, HPV-Related Carcinoma and HPV-Related Intraepithelial Neoplasia, sponsored by Shanghai Bovax Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 9 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Shanghai Bovax Biotechnology Co., Ltd. · Phase 2, Interventional, and Prevention
To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.
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.
Exclusion Criteria:
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
Biological: Medium 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
Biological: High dose for 15-HPV vaccine
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
Biological: Placebo
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
Biological: 9-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
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
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
Participants 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
Percentage of Participants With Adverse Events
AE of local and systemic reactions within 30 minutes after each dose
Time frame: Up to 30 minutes after any vaccination
Percentage of Participants With Solicited Adverse Events
The percentage of participants with one or more solicited AEs was assessed.
Time frame: Up to 14 days after any vaccination
Percentage of Participants With Unsolicited Adverse Events
Percentage of Participants With Unsolicited Adverse Events
Time frame: Up to 30 days after any vaccination
Percentage of Participants With Serious Adverse Events
The percentage of participants with one or more SAEs was assessed
Time frame: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
Percentage of Female Participants With Pregnancy Events
The percentage of participants with Pregnancy Events was assessed
Time frame: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
Immunogenicity after receiving 3 doses of 15-HPV vaccine
Geometric mean titer (GMT) of anti-vaccine containing corresponding type of neutralizing antibody in subjects aged 18-45 years on the 31-day after the third dose of immunization
Time frame: Up to 31 days after the third vaccination
Immunogenicity of 15-HPV vaccine
Seroconversion rate (SCR)of the anti-vaccine containing the corresponding type of neutralizing antibody on day 31 after total immunization in subjects aged 18-45 years
Time frame: Up to 31 days after the third vaccination
Immunogenicity after receiving 3 doses of 15-HPV vaccine among the participants
Geometric Mean Fold Increase (GMI) and 4-fold increase rates of anti-vaccine corresponding types of neutralizing antibodies in baseline seropositive subjects aged 18-45 years at day 31 after immunization
Time frame: Up to 31 days after the third vaccination
Plan to share: No
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Shanghai Bovax Biotechnology Co., Ltd.