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

NCT ID: NCT07281677

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2029-11-13

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

Detailed Description

A post-marketing study is being conducted in Zhejiang Province to evaluate the immunogenicity and safety of a sequential 2vhpv to 9vhpv immunization schedule in girls aged 9-14 years. The study plans to recruit 300 healthy participants, who will be randomly assigned in a 1:1:1 ratio to three groups. In Experimental Group A, participants will receive one dose of the bivalent HPV vaccine followed six months later by two doses of the 9-valent HPV vaccine. In Experimental Group B, participants will receive one dose of the 9-valent HPV vaccine six months after a single dose of the bivalent HPV vaccine. The control group will receive two doses of the 9-valent HPV vaccine at a six-month interval. Venous blood samples will be collected before the first dose, one month before and after each dose of the 9-valent vaccine, and at 12 and 24 months after full immunization to assess HPV vaccine-type-specific neutralizing antibodies.

In addition, 100 healthy girls will be enrolled as an external control group receiving two doses of the bivalent vaccine, with blood samples collected before each dose and at 1, 12, and 24 months post-vaccination to assess HPV vaccine-type-specific neutralizing antibodies.

Conditions

HPV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

bivalent HPV vaccine

Intervention Type: BIOLOGICAL

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

9-valent HPV vaccine

Intervention Type: BIOLOGICAL

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

Group B

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

Group Type: EXPERIMENTAL

bivalent HPV vaccine

Intervention Type: BIOLOGICAL

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

9-valent HPV vaccine

Intervention Type: BIOLOGICAL

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

Control

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

Group Type: ACTIVE_COMPARATOR

9-valent HPV vaccine

Intervention Type: BIOLOGICAL

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

External control

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

Group Type: OTHER

bivalent HPV vaccine

Intervention Type: BIOLOGICAL

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

Interventions

bivalent HPV vaccine

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

Intervention Type: BIOLOGICAL

9-valent HPV vaccine

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang Provincial Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: lead

Responsible Party

Shenyu Wang

Deputy Director, Department of Immunization Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shenyu Wang

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Provincial Center for Disease Control and Prevention

Locations

Jinyun center for Disease Control and Prevention

Lishui, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shenyu Wang

Role: CONTACT

sywang@cdc.zj.cn

0571-87115152

Xiaosong Hu

Role: CONTACT

xshu@cdc.zj.cn

0571-87115166

Facility Contacts

Luyao Ying

Role: primary

1121503448@qq.com

0578-3215307

Other Identifiers

2025-065-01

Identifier Type: -

Identifier Source: org_study_id