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

NCT07281677 | Recruiting Phase 4

• 1 other identifier: 2025-065-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the immunogenicity and safety of a sequential 2vhpv to 9vhpv immunization schedule in girls aged 9-14 years

Conditions

HPV Infection

Keywords

HPV; bivalent HPV vaccine; 9-valent HPV vaccine

Outcome Measures

Primary Outcomes (4)

• Seropositive rate of the vaccination

  The percentage of participants with positive antibody against vaccine-specific HPV

  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

• Seroconversion rate of the vaccination

  The proportion of participants who are determined to have seroconversion of Vaccine-specific HPV antibody

  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

• Geometric mean concentration (GMC)

  The GMC of vaccine-specific HPV antibody

  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

• Geometric mean increase (GMI)

  The GMI of vaccine-specific HPV antibody

  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

Secondary Outcomes (1)

• Description of AE; Incidence of AR and SAE

  within 30 minutes and within 30 days after vaccination (AE/AR); within 6 months after the entire vaccination course

Study Arms (4)

Group A

EXPERIMENTAL

Participants will receive one dose of the bivalent HPV vaccine, followed by two doses of the 9-valent HPV vaccine six months later\[2v-9v-9v (0, 6m, 12m)\].

Biological: bivalent HPV vaccine; Biological: 9-valent HPV vaccine

Group B

EXPERIMENTAL

Participants will receive one dose of the 9-valent HPV vaccine sequentially 6 months after receiving one dose of the bivalent HPV vaccine\[2v-9v(0, 6m)\].

Biological: bivalent HPV vaccine; Biological: 9-valent HPV vaccine

Control

ACTIVE COMPARATOR

Participants will receive two doses of the 9-valent HPV vaccine directly\[9v-9v(0, 6m)\].

Biological: 9-valent HPV vaccine

External control

OTHER

Participants will receive two doses of the bivalent HPV vaccine directly\[2v-2v(0, 6m)\].

Biological: bivalent HPV vaccine

Interventions

bivalent HPV vaccine BIOLOGICAL

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

External control; Group A; Group B

9-valent HPV vaccine BIOLOGICAL

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

Control; Group A; Group B

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Provincial Center for Disease Control and Prevention: lead

Study Sites (1)

Jinyun center for Disease Control and Prevention

Lishui, Zhejiang, 321400, China

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

human papillomavirus vaccine, L1 type 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shenyu Wang

  Zhejiang Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenyu Wang

CONTACT

0571-87115152; sywang@cdc.zj.cn

Xiaosong Hu

CONTACT

0571-87115166; xshu@cdc.zj.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Department of Immunization Program

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 15, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): November 13, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)