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RecruitingNCT07668271Updated Jun 25, 2026

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 interventional study of 9-valent HPV vaccine (Cecolin 9) in Infection by Human Papilloma Virus, sponsored by Xiamen Innovax Biotech Co., Ltd. Recruiting at 1 site in China. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Xiamen Innovax Biotech Co., Ltd · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
720
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Study 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 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.
02

Conditions studied

  • Infection by Human Papilloma Virus

Browse trials for

03

In context

Papilloma

88 studies on the registry are indexed under Papilloma; 19 are open to participants now.

This study's planned enrollment of 720 is above the median of 119 across 64 interventional studies indexed under Papilloma.

Browse Papilloma studies →

Lead sponsor

Xiamen Innovax Biotech Co., Ltd is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form;
  • The trial participant agrees to avoid pregnancy and use effective 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).

Exclusion criteria

Exclusion Criteria:

  • 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 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 , other immunomodulatory drugs or 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;
  • Have received inactivated vaccines within 14 days or 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, (HIV) infection, 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.), , 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 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.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
720 participants (estimated)

Study arms

  • Experimental
    Cecolin 9 - Lot 1 group

    Biological: 9-valent HPV vaccine (Cecolin 9)

  • Experimental
    Cecolin 9 - Lot 2 group

    Biological: 9-valent HPV vaccine (Cecolin 9)

  • Experimental
    Cecolin 9 - Lot 3 group

    Biological: 9-valent HPV vaccine (Cecolin 9)

Interventions

  • Biological9-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)

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: One month after full vaccination (Month 7)

Secondary outcomes

  1. 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.

    Time frame: One month after full vaccination (Month 7)

  2. 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.

    Time frame: One month after full vaccination (Month 7)

  3. 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.

    Time frame: Within 7 days after each vaccination

  4. 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.

    Time frame: Within 30 days after each vaccination

  5. Percentage of participants experiencing all AEs

    Include both solicited and unsolicited AEs.

    Time frame: Within 30 days after each vaccination

  6. 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.

    Time frame: Through study completion, an average of 7 months.

  7. Percentage of participants experiencing AESIs

    The AESIs include predominantly new-onset autoimmune diseases.

    Time frame: Through study completion, an average of 7 months.

  8. Percentage of participants experiencing pregnancy events.

    Pregnancy events include any pregnancy and its outcomes (e.g., maternal, fetal and neonatal outcomes).

    Time frame: Through study completion, an average of 7 months.

07

Study locations

1 of 1 sites recruiting
  • Zhangping Center for Disease Control and Prevention
    Zhangping, Fujian 364400, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07668271
Lead sponsor
Xiamen Innovax Biotech Co., Ltd
Responsible party
Sponsor
First posted
Jun 25, 2026
Start date
May 26, 2026
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Jun 25, 2026

Study contacts

Qiufen Zhang
Contact
qiufen_zhang@innovax.cn
+865926536555

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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