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 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.

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 Overview

• Status: Recruiting
• Conditions: Infection by Human Papilloma Virus
• Intervention / Treatment: Biological: 9-valent HPV vaccine (Cecolin 9)

• Study Type: Interventional
• Enrollment (Estimated): 720
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qiufen Zhang; Phone Number: +865926536555; Email: qiufen_zhang@innovax.cn

Study Locations

• China
  • Fujian
    • Zhangping, Fujian, China, 364400
      • Recruiting
      • Zhangping Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

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

Description

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 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).

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 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cecolin 9 - Lot 1 group	Biological: 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)
Experimental: Cecolin 9 - Lot 2 group	Biological: 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)
Experimental: Cecolin 9 - Lot 3 group	Biological: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	One month after full vaccination (Month 7)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Within 30 days after each vaccination
Percentage of participants experiencing all AEs	Include both solicited and unsolicited AEs.	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.	Through study completion, an average of 7 months.
Percentage of participants experiencing AESIs	The AESIs include predominantly new-onset autoimmune diseases.	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).	Through study completion, an average of 7 months.

Collaborators and Investigators

• Sponsor: Xiamen Innovax Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HPV-PRO-016

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