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Clinical Trial NCT07281677 for HPV Infection is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Immunogenicity and Safety of Sequential 2vHPV-9vHPV Vaccination in Girls Aged 9-14 Years Phase 4 400
Clinical Trial NCT07281677 is designed to study Prevention for HPV Infection. It is a Phase 4 interventional study that is recruiting, having started on December 20, 2025, with plans to enroll 400 participants. Led by Zhejiang Provincial Center for Disease Control and Prevention, it is expected to complete by November 13, 2029. The latest data from ClinicalTrials.gov was last updated on December 15, 2025.
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 tw...Show More
Official Title
Immunogenicity and Safety of Sequential Bivalent and 9-Valent Human Papillomavirus Vaccine Immunization in Girls Aged 9-14 Years
Conditions
HPV InfectionOther Study IDs
- 2025-065-01
NCT ID Number
Start Date (Actual)
2025-12-20
Last Update Posted
2025-12-15
Completion Date (Estimated)
2029-11-13
Enrollment (Estimated)
400
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
HPV
bivalent HPV vaccine
9-valent HPV vaccine
bivalent HPV vaccine
9-valent HPV vaccine
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalGroup A Participants will receive one dose of the bivalent HPV vaccine, followed by two doses of the 9-valent HPV vaccine six months later\[2v-9v-9v (0, 6m, 12m)\]. | 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. |
ExperimentalGroup B Participants will receive one dose of the 9-valent HPV vaccine sequentially 6 months after receiving one dose of the bivalent HPV vaccine\[2v-9v(0, 6m)\]. | 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. |
Active ComparatorControl Participants will receive two doses of the 9-valent HPV vaccine directly\[9v-9v(0, 6m)\]. | 9-valent HPV vaccine 9-valent HPV vaccine is produced by Wantai BioPharm or Merck Sharp \& Dohme LLC. |
OtherExternal control Participants will receive two doses of the bivalent HPV vaccine directly\[2v-2v(0, 6m)\]. | bivalent HPV vaccine Bivalent HPV vaccine produced by Shanghai Zerun Biotechnology Co.,Ltd. or Wantai BioPharm. |
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
9 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
- 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.
- 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.
Zhejiang Provincial Center for Disease Control and PreventionStudy Responsible Party
Shenyu Wang, Principal Investigator, Deputy Director, Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention
Study Central Contact
Contact: Shenyu Wang, 0571-87115152, [email protected]
Contact: Xiaosong Hu, 0571-87115166, [email protected]
1 Study Locations in 1 Countries
Zhejiang
Jinyun center for Disease Control and Prevention, Lishui, Zhejiang, 321400, China
Luyao Ying, Contact, 0578-3215307, [email protected]
Recruiting