Active, not recruitingNCT05056402Updated Jul 22, 2025

An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs Aged 18-26 Years Old

A Phase 3 interventional study of 3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli) and 2 doses of theRecombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli) in Cervical Cancer and Condylomata Acuminata, sponsored by Xiamen University. Active, not recruiting at 1 site in China. Open to participants aged 9 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-22.

Sponsored by Xiamen University · Phase 3, Interventional, and Prevention

From the registry’s dates

Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.

Phase: Phase 3
Study type: Interventional
Enrollment: 1,382
Allocation: Randomized
Ages: 9 Years to 26 Years
Sex: All

Study summary

This is a open label clinical trial to evaluate the safety and immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., in healthy population aged 9-17 years old in comparison with aged 18-26.

Conditions studied

Cervical Cancer
Condylomata Acuminata

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Keywords

human papillomavirus vaccine
immunogenicity

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 1,382 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Xiamen University is the lead sponsor of 26 studies on the registry; 7 are open to participants now.

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

Who can participate

Ages eligible: 9 Years to 26 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subject is female between and including 9-26 years of age, or male between and including 9-17 years of age at the first vaccination;
Subject (and their legal guardian) is able to understand and comply with the requirements of the protocol(e.g. biological specimen collection, completion of the diary cards, return for follow-up visits), and written informed consent must be obtained from the subject prior to enrollment;
Adolescent female subject who agrees to practice effective contraception within 8 months after the first vaccination or has undergone tubal ligation,subtotal hysterectomy for benign lesion, ovarian benign tumor resection;
No previous history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, venereal lymphogranuloma, groin granuloma, etc.);
Male, or female without previous history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN);

Exclusion criteria

Exclusion Criteria:

Axillary temperature > 37.2℃;
Adolescent female subject who has a positive urine pregnancy test, or is pregnant or breastfeeding;
Subject has used of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine or plans to use during the study period , or has participated in another clinical research in the past two years, or plans to participate in another research during the study period;
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs or systemic corticosteroids (Except intranasal steroid, the use of low dose topical, ophthalmic and inhaled steroid preparations will be permitted.) within 6 months prior to vaccination.
Administration of immunoglobulin and/or blood products within 3 months prior to vaccination or planned to use them within 7 months after the first dose.
Administration of inactivated vaccine within 14 days prior to vaccination or live vaccine within 21 days;
Fever (Axillary temperature ≥38.0℃) 3 days prior to vaccination or system administration of antibiotics or antiviral agents within 5 days, or medicines containing antipyretic ingredients within 24 hours prior to vaccination;
Subject has received other HPV vaccines or participated in clinical research related to HPV or cervical cancer previously;
Subject has severe immunodeficiency disease, severe primary disease of important viscera, cancer and autoimmune disease (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy due to any condition, and other immunological diseases that investigators believe may influence the immune response).
History of severe allergy (e.g., anaphylaxis, generalized urticaria, dyspnea, angioedema, and other significant reaction) to any previous vaccination, or be allergic to any of the components of the study vaccines.
Asthma, which has been unstable for the past two years and requires emergency treatment, hospitalization, oral or intravenous corticosteroids;
Subject has serious medical disorders;
Self-report (subject and their legal guardian) coagulation disorders or abnormal coagulation function;
Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years prior to abstinence or simple epilepsy that does not require treatment in the past 3 years;
Medical, psychological, social conditions, occupation or other factors, which considered by the investigator that may influence the conduct of the clinical study.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,382 participants (actual)

Study arms

Experimental
9-17y (0,6m)
Subjects who aged 9-17 years old would receive 2 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) .
Biological: 2 doses of theRecombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
Experimental
9-17y (0,1,6m)
Subjects who aged 9-17 years old would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) .
Biological: 3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
Experimental
18-26y (0,1,6m)
Subjects who aged 18-26 years old would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) .
Biological: 3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)

Interventions

Biological3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
Three doses administered intramuscularly at 0, 1 and 6 month.
Biological2 doses of theRecombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
Two doses administered intramuscularly at 0 and 6 month.

What researchers measure

Primary outcomes

Immunogenicity1: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at Months 7 in the population aged 9-26 years old receiving 3 doses of the nonavalent vaccine
To determine whether the immune responses (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at month 7 (one month after the final dose) in the population aged 9-17 years receiving 3 doses of the nonavalent vaccine are noninferior to those in women aged 18-26 years receiving 3 doses of vaccine.
Time frame: 7 months after the first dose

Secondary outcomes

Immunogenicity2: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at Months 7 in the population aged 9-14 years old receiving 2 doses of the nonavalent vaccine
To determine whether the immune responses (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at month 7 (one month after the final dose) in the population aged 9-14 years receiving 2 doses of the nonavalent vaccine are noninferior to those in women aged 18-26 years receiving 3 doses of vaccine.
Time frame: 7 months after the first dose
Immunogenicity3: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at months 18 and 30 in the population aged 9-14 and 15-17 years old receiving 2 doses or 3 doses of the nonavalent vaccine
To determine the immune persistence (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at months 18 and 30 in the population receiving 2 doses or 3 doses of the nonavalent vaccine
Time frame: 30 months after the first dose
Safety1: Local and systematic adverse events/reactions occurred within 7 days after each vaccination.
Local and systematic adverse events/reactions occurred within 7 days after each vaccination.
Time frame: During the 7-day period following each vaccination
Safety2: Adverse events/reactions occurred within 30 days after each vaccination.
Adverse events/reactions occurred within 30 days after each vaccination.
Time frame: Within 30 days (Day 0-30) after any vaccination
Safety3: Severe adverse events occurred throughout the study.
Severe adverse events occurred throughout the study. To evaluate number of SAEs between the different arms.
Time frame: Up to 8 month
Safety4: Pregnancy and pregnancy outcome.
Pregnancy and pregnancy outcome. To evaluate number of births and terminations between the different arms.
Time frame: Up to 8 month

Study locations

1 site

Sichuan Provincial Centre for Disease Control and Prevention
Chengdu, Sichuan 610041, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05056402
Lead sponsor: Xiamen University
Collaborators: Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Responsible party: Jun Zhang (professor, Xiamen University) — Principal investigator
First posted: Sep 24, 2021
Start date: Sep 19, 2021
Primary completion: Dec 31, 2025 (estimated)
Completion: Dec 31, 2025 (estimated)
Last update: Jul 22, 2025

Study contacts

Jun Zhang, master

study chair · Xiamen University

Xue-cheng Liu, master

principal investigator · Sichuan Provincial Centre for Disease Control and Prevention

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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