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

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

Study Overview

• Status: Recruiting
• Conditions: HPV Infection
• Intervention / Treatment: Biological: bivalent HPV vaccine; Biological: 9-valent HPV vaccine

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shenyu Wang; Phone Number: 0571-87115152; Email: sywang@cdc.zj.cn
• Study Contact Backup: Name: Xiaosong Hu; Phone Number: 0571-87115166; Email: xshu@cdc.zj.cn

Study Locations

• China
  • Zhejiang
    • Lishui, Zhejiang, China, 321400
      • Recruiting
      • Jinyun center for Disease Control and Prevention
      • Contact: Luyao Ying; Phone Number: 0578-3215307; Email: 1121503448@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)].	Biological: bivalent HPV vaccine; Bivalent HPV vaccine produced by Shanghai Zerun Biotechnology Co.,Ltd. or Wantai BioPharm.; Biological: 9-valent HPV vaccine; 9-valent HPV vaccine is produced by Wantai BioPharm or Merck Sharp & Dohme LLC.
Experimental: 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)].	Biological: bivalent HPV vaccine; Bivalent HPV vaccine produced by Shanghai Zerun Biotechnology Co.,Ltd. or Wantai BioPharm.; Biological: 9-valent HPV vaccine; 9-valent HPV vaccine is produced by Wantai BioPharm or Merck Sharp & Dohme LLC.
Active Comparator: Control; Participants will receive two doses of the 9-valent HPV vaccine directly[9v-9v(0, 6m)].	Biological: 9-valent HPV vaccine; 9-valent HPV vaccine is produced by Wantai BioPharm or Merck Sharp & Dohme LLC.
Other: External control; Participants will receive two doses of the bivalent HPV vaccine directly[2v-2v(0, 6m)].	Biological: bivalent HPV vaccine; Bivalent HPV vaccine produced by Shanghai Zerun Biotechnology Co.,Ltd. or Wantai BioPharm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of AE; Incidence of AR and SAE	Describe AE according to study group, site of occurrence, severity, and relevance; calculate the incidence rates of AR and SAE.	within 30 minutes and within 30 days after vaccination (AE/AR); within 6 months after the entire vaccination course

Collaborators and Investigators

• Sponsor: Zhejiang Provincial Center for Disease Control and Prevention
• Investigators: Principal Investigator: Shenyu Wang, Zhejiang Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2025
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): November 13, 2029

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: HPV; bivalent HPV vaccine; 9-valent HPV vaccine
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Papillomavirus Infections; human papillomavirus vaccine, L1 type 16, 18
• Other Study ID Numbers: 2025-065-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No