HPV InfectionPhase 4NCT07281677
Immunogenicity and Safety of Sequential 2vHPV-9vHPV Vaccination in Girls Aged 9-14 Years
A Phase 4 study testing bivalent HPV vaccine and 9-valent HPV vaccine in people with HPV Infection, run by Zhejiang Provincial Center for Disease Control and Prevention at 1 site in China.
Trial summary
This study aims to assess the immunogenicity and safety of a sequential 2vhpv to 9vhpv immunization schedule in girls aged 9-14 years Read more about this study
- Who is it for?
- Ages 9 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection
- What is being tested?
- bivalent HPV vaccine and 9-valent HPV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2025to 13 Nov 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Jinyun center for Disease Control and Prevention
Lishui, Zhejiang, 321400
About this study
Official title: 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
Read the 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, before and one month 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.
Furthermore, 6 participants from each of the following groups who received the Wantai or Merck Sharp \& Dohme HPV vaccine were selected as the cellular immune subgroup: Experimental Group A (2vhpv[Cecolin]-9vhpv[Cecolin 9]- 9vhpv[Cecolin 9] and 2vhpv[Cecolin]-9vhpv[Gardasil 9]-9vhpv[Gardasil 9]), Experimental Group B (2vhpv[Cecolin]-9vhpv[Cecolin 9] and 2vhpv[Cecolin] -9vhpv[Gardasil 9]), control group (9vhpv[Cecolin 9]-9vhpv[Cecolin 9] and 9vhpv[Gardasil 9]-9vhpv[Gardasil 9]), and external control group (2vhpv[Cecolin] -2vhpv[Cecolin]). For the cellular immune subgroup of Experimental Group A, venous blood samples were collected before the second dose (9-valent vaccine), at 7 days and 1 month after the second dose, and at 1 month after the third dose (9-valent vaccine) to isolate plasma and PBMCs. For the cellular immune subgroups of Experimental Group B, the control group, and the external control group, venous blood samples were collected before the second dose, at 7days and 1 month after the second dose to isolate plasma and PBMCs for analysis of antigen-specific cellular response characteristics.
- Conditions
- HPV Infection
- Being tested
- bivalent HPV vaccine, 9-valent HPV vaccine
- Keywords
- HPV, bivalent HPV vaccine, 9-valent HPV vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bivalent HPV vaccineBiological
Bivalent HPV vaccine produced by Shanghai Zerun Biotechnology Co.,Ltd. or Wantai BioPharm.
9-valent HPV vaccineBiological
9-valent HPV vaccine is produced by Wantai BioPharm or Merck Sharp \& Dohme LLC.
| Study group | Role | What they receive |
|---|---|---|
| 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)]. Receives: 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)]. Receives: 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)]. Receives: Biological: 9-valent HPV vaccine |
| External control | Other | Participants will receive two doses of the bivalent HPV vaccine directly[2v-2v(0, 6m)]. Receives: Biological: bivalent HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seropositive rate of the vaccination
The percentage of participants with positive antibody against vaccine-specific HPV
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Describe AE according to study group, site of occurrence, severity, and relevance; calculate the incidence rates of AR and SAE.
Measured: within 30 minutes and within 30 days after vaccination (AE/AR); within 6 months after the entire vaccination course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start20 Dec 2025
- Primary completion20 Dec 2028 (estimated)
- Study completion13 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shenyu Wang, Zhejiang Provincial Center for Disease Control and Prevention
- Investigators
- Shenyu Wang, Principal investigator, Zhejiang Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281677
- Sponsor's protocol ID
- 2025-065-01
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Sequential Bivalent and 9-Valent Human Papillomavirus Vaccine Immunization in Girls Aged 9-14 Years
- ClinicalTrials.gov ID
- NCT07281677
- Acronym / sponsor ID
- 2025-065-01
- Conditions
- HPV Infection
- Keywords
- HPV, bivalent HPV vaccine, 9-valent HPV vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and PreventionOther government
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 13 Nov 2029 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, before and one month 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.
Furthermore, 6 participants from each of the following groups who received the Wantai or Merck Sharp \& Dohme HPV vaccine were selected as the cellular immune subgroup: Experimental Group A (2vhpv[Cecolin]-9vhpv[Cecolin 9]- 9vhpv[Cecolin 9] and 2vhpv[Cecolin]-9vhpv[Gardasil 9]-9vhpv[Gardasil 9]), Experimental Group B (2vhpv[Cecolin]-9vhpv[Cecolin 9] and 2vhpv[Cecolin] -9vhpv[Gardasil 9]), control group (9vhpv[Cecolin 9]-9vhpv[Cecolin 9] and 9vhpv[Gardasil 9]-9vhpv[Gardasil 9]), and external control group (2vhpv[Cecolin] -2vhpv[Cecolin]). For the cellular immune subgroup of Experimental Group A, venous blood samples were collected before the second dose (9-valent vaccine), at 7 days and 1 month after the second dose, and at 1 month after the third dose (9-valent vaccine) to isolate plasma and PBMCs. For the cellular immune subgroups of Experimental Group B, the control group, and the external control group, venous blood samples were collected before the second dose, at 7days and 1 month after the second dose to isolate plasma and PBMCs for analysis of antigen-specific cellular response characteristics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: bivalent HPV vaccine, Biological: 9-valent HPV vaccineParticipants 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 B | Experimental | Biological: bivalent HPV vaccine, Biological: 9-valent HPV vaccineParticipants 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)]. |
| Control | Active comparator | Biological: 9-valent HPV vaccineParticipants will receive two doses of the 9-valent HPV vaccine directly[9v-9v(0, 6m)]. |
| External control | Other | Biological: bivalent HPV vaccineParticipants will receive two doses of the bivalent HPV vaccine directly[2v-2v(0, 6m)]. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bivalent HPV vaccineBivalent HPV vaccine produced by Shanghai Zerun Biotechnology Co.,Ltd. or Wantai BioPharm. | Biological | External control, Group A, Group B |
| 9-valent HPV vaccine9-valent HPV vaccine is produced by Wantai BioPharm or Merck Sharp \& Dohme LLC. | Biological | Control, Group A, Group B |
Primary outcome
Seropositive rate of the vaccination
Time frame: 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
The percentage of participants with positive antibody against vaccine-specific HPV
Seroconversion rate of the vaccination
Time frame: 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
The proportion of participants who are determined to have seroconversion of Vaccine-specific HPV antibody
Geometric mean concentration (GMC)
Time frame: 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
The GMC of vaccine-specific HPV antibody
Geometric mean increase (GMI)
Time frame: 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
The GMI of vaccine-specific HPV antibody
1 secondary outcome
Description of AE; Incidence of AR and SAE
Time frame: within 30 minutes and within 30 days after vaccination (AE/AR); within 6 months after the entire vaccination course
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shenyu Wang principal investigator
Zhejiang Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bivalent HPV vaccine and 9-valent HPV vaccine in people with HPV Infection, run by Zhejiang Provincial Center for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seropositive rate of the vaccination (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.