Active — Not RecruitingPhase 3

Phase IIIb Clinical Trial of Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) for Age/Immunization Schedule Bridging

China1,800 participantsStarted 2025-11-21

Plain-language summary

This vaccine was jointly developed by Chengdu Institute of Biological Products Co., Ltd. and National Vaccine and Serum Institute, China, is co-sponsoring this clinical trial. This trial plans to enroll 1,800 female subjects aged 9-35 years, 450 in each of the 18-25 years old 3-dose group, 26-35 years old 3-dose group, 9-17 years old 3-dose group and 9-14 years old 2-dose group. All subjects in the 9-14 years old 2-dose group will be injected with 2 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0-6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 6 on-site visits and subjects in the immune persistence subgroup will need to complete 13 on-site visits ; All subjects in the 9-17 years old 3-dose group and the 18-35 years old 3-dose group will be injected with 3 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0, 2, and 6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 9 on-site visits and subjects in the immune persistence subgroup will need to complete 16 on-site visits

Who can participate

Age range

9 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Females aged 9-35 years at the time of enrollment; * Subjects aged 9-17 years at the time of enrollment and at least one legal guardian are informed and willing to participate, sign the informed consent form and can provide valid identity documents; subjects aged 18-35 years at the time of enrollment are informed and willing to participate, sign the informed consent form and can provide valid identity documents; * Subjects are able to understand the research procedures and cooperate with the requirements of the clinical trial to participate in regular follow-up; * Female subjects of childbearing age have a negative urine pregnancy test on the day of enrollment, are not breastfeeding and have no fertility plans within 7 months after enrollment; have taken effective contraceptive measures since the end of the last menstruation until enrollment, and agree to continue to use effective contraceptive measures within 7 months after participating in the study (effective contraceptive measures include: oral contraceptives, injections or implants, sustained-release local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.); * Body temperature ≤37.0℃ (axillary temperature) on the day of enrollment. Exclusion Criteria: First dose exclusion criteria * Those who have received a commercially available HPV vaccine in the past or plan to receive a commercially available HPV vaccine d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among subjects who were seronegative at baseline (pre-vaccination)

Timeframe: 1 month after completion of the vaccination series

Trial details

NCT IDNCT06632912

SponsorNational Vaccine and Serum Institute, China

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2032-07

View on ClinicalTrials.gov More Human Papillomavirus (HPV) Infection trials