RecruitingPhase 4NCT07281677

Immunogenicity and Safety of Sequential 2vHPV-9vHPV Vaccination in Girls Aged 9-14 Years

Immunogenicity and Safety of Sequential Bivalent and 9-Valent Human Papillomavirus Vaccine Immunization in Girls Aged 9-14 Years


Sponsor

Zhejiang Provincial Center for Disease Control and Prevention

Enrollment

400 participants

Start Date

Dec 20, 2025

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 9 YearsMax Age: 14 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALbivalent HPV vaccine

Bivalent HPV vaccine produced by Shanghai Zerun Biotechnology Co.,Ltd. or Wantai BioPharm.

BIOLOGICAL9-valent HPV vaccine

9-valent HPV vaccine is produced by Wantai BioPharm or Merck Sharp \& Dohme LLC.


Locations(1)

Jinyun center for Disease Control and Prevention

Lishui, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07281677


Related Trials