Zhejiang Provincial Center for Disease Control and Prevention
Phase
Phase 4
Started
2025-12-20
Last updated
2026-06-11
Condition(s) studied
HPV Infection
Investigational drug(s) / intervention(s)
bivalent HPV vaccine9-valent HPV vaccine
bivalent HPV vaccine: Bivalent HPV vaccine produced by Shanghai Zerun Biotechnology Co.,Ltd. or Wantai BioPharm.
9-valent HPV vaccine: 9-valent HPV vaccine is produced by Wantai BioPharm or Merck Sharp \& Dohme LLC.
Study summary
This study aims to assess the immunogenicity and safety of a sequential 2vhpv to 9vhpv immunization schedule in girls aged 9-14 years
Eligibility
Sex
FEMALE
Min age
9 Years
Max age
14 Years
Healthy volunteers
Accepted
Inclusion Criteria
* Have not received any HPV vaccine products.
* Girls aged 9 to 14 years.
* Reside permanently at the research site. Both the participant and her legal guardian have voluntarily agreed to participate, have signed the informed consent form, understand and agree to comply with the study protocol, and are able to complete all scheduled blood collections and follow-up visits.
Exclusion Criteria
* Suspected or confirmed fever (≥38.5°C) within 72 hours prior to enrollment, or axillary temperature \>37.0°C on the day of enrollment.
* HIV infection or other immunocompromising conditions.
* Presence of acute illness or being in the acute phase of a chronic disease.
* History of severe allergic reactions to any component of the study vaccine or to previous vaccinations.
* Contraindications to intramuscular injection, such as thrombocytopenia, coagulation disorders, or current anticoagulant therapy.
* Receipt of non-live vaccines within 14 days or live attenuated vaccines within 28 days prior to HPV vaccination in this study.
* Receipt of blood or blood-derived products within 3 months prior to enrollment, or planned use within 6 months from the first vaccination to completion of the full vaccination schedule.
* Any disease or condition deemed by the investigator to place the participant at unacceptable risk, prevent adherence to study requirements, or interfere with the assessment of vaccine responses.
Primary outcome measure(s)
Seropositive rate of the vaccination — Before the first vaccine, before and 1 month after each dose of the 9-valent vaccine, and 12 and 24 months after the entire vaccination course. External Control Group: Before each vaccine, and 1, 12, and 24 months after the entire vaccination course The percentage of participants with positive antibody against vaccine-specific HPV
Seroconversion rate of the vaccination — Before the first vaccine, before and 1 month after each dose of the 9-valent vaccine, and 12 and 24 months after the entire vaccination course. External Control Group: Before each vaccine, and 1, 12, and 24 months after the entire vaccination course The proportion of participants who are determined to have seroconversion of Vaccine-specific HPV antibody
Geometric mean concentration (GMC) — Before the first vaccine, before and 1 month after each dose of the 9-valent vaccine, and 12 and 24 months after the entire vaccination course. External Control Group: Before each vaccine, and 1, 12, and 24 months after the entire vaccination course The GMC of vaccine-specific HPV antibody
Geometric mean increase (GMI) — Before the first vaccine, before and 1 month after each dose of the 9-valent vaccine, and 12 and 24 months after the entire vaccination course. External Control Group: Before each vaccine, and 1, 12, and 24 months after the entire vaccination course The GMI of vaccine-specific HPV antibody
Trial sites (1)
Facility
City
Region
Status
Jinyun center for Disease Control and Prevention
Lishui
Zhejiang
More Zhejiang Provincial Center for Disease Control and Prevention trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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