Infection by Human Papilloma VirusPhase 4NCT07668271
Lot-to-Lot Consistency Clinical Trial of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli)
A Phase 4 study testing 9-valent HPV vaccine (Cecolin 9) in people with Infection by Human Papilloma Virus, run by Xiamen Innovax Biotech Co., Ltd at 1 site in China.
Trial summary
To support international market access and comply with World Health Organization Prequalification requirements, this lot-to-lot consistency trial is planned for initiation. The goal of this clinical trial is to evaluate lot-to-lot immunogenicity and safety of Recombinant Human Papillomavirus 9-valent (Types… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infection by Human Papilloma Virus
- What is being tested?
- 9-valent HPV vaccine (Cecolin 9)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2026to 28 Feb 2027
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese female participants aged 18 to 30 years old who can provide legal identity documentation at screening, i.e., at least 18 years of age and less than 31 years of age;
- The trial participant is able to understand trial procedures and comply with protocol requirements (including biological sample collection, completion of diary/contact cards, and attendance of scheduled follow-up visits), and voluntarily signs the informed consent form;
- The trial participant agrees to avoid pregnancy and use effective contraceptive measures from the first vaccination through 1 month after completion of full vaccination;
- No prior history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, lymphogranuloma venereum, granuloma inguinale, etc.);
- No prior history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN).
Who cannot join
- Have previously received any HPV vaccine, plan to receive any HPV vaccine not supplied in this trial during the study period, or have participated in any clinical trial related to HPV vaccines;
- Axillary temperature > 37.0°C;
- Positive urine pregnancy test, current pregnancy or breastfeeding status;
- Have received any other investigational or unlicensed products (medicines or vaccines) within 30 days prior to administration of the investigational vaccine, or plan to receive such products or enroll in another clinical trial during the study;
- Have received systemic immunosuppressants, other immunomodulatory drugs or corticosteroids for a prolonged duration (≥14 consecutive days) within 6 months before vaccination. Local treatments (e.g., ointments, eye drops, inhalants or nasal sprays) are permitted;
- Have received immunoglobulins and/or blood products within 3 months prior to vaccination, or plan to receive such products within 7 months after the first vaccination;
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- Have received inactivated vaccines within 14 days or live vaccines within 21 days before vaccine administration;
- Axillary temperature > 38.0°C within 3 days prior to vaccination, or any acute disease requiring systemic antibiotic or antiviral therapy within 5 days prior to vaccination;
- Current immunocompromised status, including congenital or acquired immunodeficiency disorders, Human Immunodeficiency Virus (HIV) infection, autoimmune diseases (including asplenia or splenectomy of any cause and other autoimmune diseases deemed likely to interfere with immune response by the investigator), diseases of major organs (heart, liver, spleen, lung, kidney, etc.), malignancy, etc.;
- History of hypertension or hypotension with regular medication but unstable control; or resting brachial blood pressure readings of the trial participant showing systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg, or systolic blood pressure <90 mmHg; or with other concomitant diseases judged unsuitable for this trial after comprehensive assessment by the investigator;
- Prior or current severe illnesses with unstable conditions that may require emergency treatment or hospitalization;
- History of severe allergies, including severe adverse reactions to previous vaccinations such as dyspnea or angioedema, or known hypersensitivity to any component of the investigational vaccine (recombinant VLP protein, sodium dihydrogen phosphate, disodium hydrogen phosphate, polysorbate, aluminium hydroxide);
- Asthma with unstable disease requiring emergency care, hospitalization, oral or intravenous corticosteroid administration in the past two years;
- Prior or current coagulation dysfunction or coagulation disorders;
- Epilepsy, excluding febrile convulsions occurring before 2 years of age, alcoholic seizures within the first 3 years of alcohol withdrawal, or simple epilepsy that has required no treatment for the past 3 years;
- Participants judged by the investigator, after medical history inquiry and relevant physical examination, to have medical, psychological, social, occupational or other conditions that may interfere with the conduct of the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhangping Center for Disease Control and Prevention
Zhangping, Fujian, 364400
About this study
Official title: A Single-center, Randomized, Double-blind, Phase IV Lot-to-lot Consistency Clinical Trial in 18-30 Years-old Females in China to Evaluate Immunogenicity and Safety of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli)
To support international market access and comply with World Health Organization Prequalification requirements, this lot-to-lot consistency trial is planned for initiation. The goal of this clinical trial is to evaluate lot-to-lot immunogenicity and safety of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli) in 18-30 years-old females in China. The main question it aims to answer is:
- Is immunogenicity consistent across three commercially produced batches of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia coli)? Researchers will compare the immune responses at 1 month post full vaccination to see if the lot-to-lot consistency of immunogenicity can be achieved.
Read more
Participants will:
- Visit the clinic site on Month 0, 1, 2, 6 and 7.
- Take 3 doses of investigational vaccine on Month 0, 1 and 6.
- Provide approximately 5.0 mL venous blood samples on Month 0 and Month 7.
- Keep a diary of their adverse events (AEs) within 30 days after each vaccination.
- Report serious adverse events (SAEs), adverse events of special interest (AESIs), and pregnancies occurring during the trial.
- Conditions
- Infection by Human Papilloma Virus
- Being tested
- 9-valent HPV vaccine (Cecolin 9)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-valent HPV vaccine (Cecolin 9)Biological
Recombinant human papillomavirus 9-valent (types 6/11/16/18/31/33/45/52/58) vaccine (Escherichia Coli) (Xiamen Innovax Biotech Co., Ltd., Xiamen, China)
| Study group | Role | What they receive |
|---|---|---|
| Cecolin 9 - Lot 1 group | Experimental | Not described Receives: Biological: 9-valent HPV vaccine (Cecolin 9) |
| Cecolin 9 - Lot 2 group | Experimental | Not described Receives: Biological: 9-valent HPV vaccine (Cecolin 9) |
| Cecolin 9 - Lot 3 group | Experimental | Not described Receives: Biological: 9-valent HPV vaccine (Cecolin 9) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean concentrations (GMCs) of naturalizing antibody to HPV6/11/16/18/31/33/45/52/58
Type-specific (HPV6/11/16/18/31/33/45/52/58) naturalizing antibody GMCs. Neutralizing antibody testing will adopt the pseudovirus-based neutralization assay (PBNA).
Measured: One month after full vaccination (Month 7)
Secondary outcomes (8)
Seroconversion rates of naturalizing antibody to HPV6/11/16/18/31/33/45/52/58
Type-specific (HPV6/11/16/18/31/33/45/52/58) naturalizing antibody seroconversion rates. Neutralizing antibody testing will adopt the PBNA. The percentage of participants with a ≥4-fold increase in antibody level relative to baseline for each HPV type.
Measured: One month after full vaccination (Month 7)
Seropositivity rates of naturalizing antibody to HPV6/11/16/18/31/33/45/52/58
Type-specific (HPV6/11/16/18/31/33/45/52/58) naturalizing antibody seropositivity rates. Neutralizing antibody testing will adopt the PBNA. The percentage of participants who are seropositive for each HPV type.
Measured: One month after full vaccination (Month 7)
Percentage of participants experiencing solicited adverse events (AEs)
Solicited AEs include (1) solicited local AEs: injection-site pain, induration, erythema, swelling, pruritus; (2) solicited systemic AEs: fever, hypersensitivity reactions, headache, dizziness, fatigue, asthenia, nausea, vomiting, diarrhoea, myalgia and cough.
Measured: Within 7 days after each vaccination
Percentage of participants experiencing unsolicited AEs
Unsolicited AEs include all AEs other than solicited AEs that occur within 7 days after vaccination, as well as all AEs occur between Day 8 and Day 30.
Measured: Within 30 days after each vaccination
Percentage of participants experiencing all AEs
Include both solicited and unsolicited AEs.
Measured: Within 30 days after each vaccination
Percentage of participants experiencing SAEs
A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Measured: Through study completion, an average of 7 months.
Percentage of participants experiencing AESIs
The AESIs include predominantly new-onset autoimmune diseases.
Measured: Through study completion, an average of 7 months.
Percentage of participants experiencing pregnancy events.
Pregnancy events include any pregnancy and its outcomes (e.g., maternal, fetal and neonatal outcomes).
Measured: Through study completion, an average of 7 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start26 May 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection by Human Papilloma VirusStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Innovax Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668271
- Sponsor's protocol ID
- HPV-PRO-016
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 25 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Phase IV Lot-to-lot Consistency Clinical Trial in 18-30 Years-old Females in China to Evaluate Immunogenicity and Safety of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli)
- ClinicalTrials.gov ID
- NCT07668271
- Acronym / sponsor ID
- HPV-PRO-016
- Conditions
- Infection by Human Papilloma Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Xiamen Innovax Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 May 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 25 Jun 2026 (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.
To support international market access and comply with World Health Organization Prequalification requirements, this lot-to-lot consistency trial is planned for initiation. The goal of this clinical trial is to evaluate lot-to-lot immunogenicity and safety of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli) in 18-30 years-old females in China. The main question it aims to answer is:
- Is immunogenicity consistent across three commercially produced batches of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia coli)? Researchers will compare the immune responses at 1 month post full vaccination to see if the lot-to-lot consistency of immunogenicity can be achieved.
Participants will:
- Visit the clinic site on Month 0, 1, 2, 6 and 7.
- Take 3 doses of investigational vaccine on Month 0, 1 and 6.
- Provide approximately 5.0 mL venous blood samples on Month 0 and Month 7.
- Keep a diary of their adverse events (AEs) within 30 days after each vaccination.
- Report serious adverse events (SAEs), adverse events of special interest (AESIs), and pregnancies occurring during the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cecolin 9 - Lot 1 group | Experimental | Biological: 9-valent HPV vaccine (Cecolin 9) |
| Cecolin 9 - Lot 2 group | Experimental | Biological: 9-valent HPV vaccine (Cecolin 9) |
| Cecolin 9 - Lot 3 group | Experimental | Biological: 9-valent HPV vaccine (Cecolin 9) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese female participants aged 18 to 30 years old who can provide legal identity documentation at screening, i.e., at least 18 years of age and less than 31 years of age;
- The trial participant is able to understand trial procedures and comply with protocol requirements (including biological sample collection, completion of diary/contact cards, and attendance of scheduled follow-up visits), and voluntarily signs the informed consent form;
- The trial participant agrees to avoid pregnancy and use effective contraceptive measures from the first vaccination through 1 month after completion of full vaccination;
- No prior history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, lymphogranuloma venereum, granuloma inguinale, etc.);
- No prior history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN).
Key exclusion criteria (16 listed)
- Have previously received any HPV vaccine, plan to receive any HPV vaccine not supplied in this trial during the study period, or have participated in any clinical trial related to HPV vaccines;
- Axillary temperature > 37.0°C;
- Positive urine pregnancy test, current pregnancy or breastfeeding status;
- Have received any other investigational or unlicensed products (medicines or vaccines) within 30 days prior to administration of the investigational vaccine, or plan to receive such products or enroll in another clinical trial during the study;
- Have received systemic immunosuppressants, other immunomodulatory drugs or corticosteroids for a prolonged duration (≥14 consecutive days) within 6 months before vaccination. Local treatments (e.g., ointments, eye drops, inhalants or nasal sprays) are permitted;
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 |
|---|---|---|
| 9-valent HPV vaccine (Cecolin 9)Recombinant human papillomavirus 9-valent (types 6/11/16/18/31/33/45/52/58) vaccine (Escherichia Coli) (Xiamen Innovax Biotech Co., Ltd., Xiamen, China) | Biological | Cecolin 9 - Lot 1 group, Cecolin 9 - Lot 2 group, Cecolin 9 - Lot 3 group |
Primary outcome
Geometric mean concentrations (GMCs) of naturalizing antibody to HPV6/11/16/18/31/33/45/52/58
Time frame: One month after full vaccination (Month 7)
Type-specific (HPV6/11/16/18/31/33/45/52/58) naturalizing antibody GMCs. Neutralizing antibody testing will adopt the pseudovirus-based neutralization assay (PBNA).
8 secondary outcomes
Seroconversion rates of naturalizing antibody to HPV6/11/16/18/31/33/45/52/58
Time frame: One month after full vaccination (Month 7)
Seropositivity rates of naturalizing antibody to HPV6/11/16/18/31/33/45/52/58
Time frame: One month after full vaccination (Month 7)
Percentage of participants experiencing solicited adverse events (AEs)
Time frame: Within 7 days after each vaccination
Percentage of participants experiencing unsolicited AEs
Time frame: Within 30 days after each vaccination
Percentage of participants experiencing all AEs
Time frame: Within 30 days after each vaccination
Percentage of participants experiencing SAEs
Time frame: Through study completion, an average of 7 months.
Percentage of participants experiencing AESIs
Time frame: Through study completion, an average of 7 months.
Percentage of participants experiencing pregnancy events.
Time frame: Through study completion, an average of 7 months.
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 25 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.
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 9-valent HPV vaccine (Cecolin 9) in people with Infection by Human Papilloma Virus, run by Xiamen Innovax Biotech Co., Ltd 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 25 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?
Contact Qiufen Zhang (+865926536555, qiufen_zhang@innovax.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean concentrations (GMCs) of naturalizing antibody to HPV6/11/16/18/31/33/45/52/58 (time frame: One month after full vaccination (Month 7)). 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 25 Jun 2026.