Cervical CancerPhase 3NCT05056402

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 study testing 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 people with Cervical Cancer and Condylomata Acuminata, run by Xiamen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 9 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Cervical Cancer, Condylomata Acuminata
What is being tested?: 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)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,382 participants
Where: 1 siteChina
Study dates: 19 Sep 2021to 31 Dec 2025
Phase: Phase 3
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 26 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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);

Who cannot join

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;

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: Immunogenicity Non-inferiority Immuno-bridging Study of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine (E.Coli) in Healthy Population Aged 9-17 Years Old vs Aged 18-26 Years Old

Conditions: Cervical Cancer, Condylomata Acuminata
Being tested: 3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli), 2 doses of theRecombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
Keywords: human papillomavirus vaccine, immunogenicity
Medical subject headings: Uterine Cervical Neoplasms, Condylomata Acuminata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05056402
Study group	Role	What they receive
9-17y (0,6m)	Experimental	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) . Receives: Biological: 2 doses of theRecombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
9-17y (0,1,6m)	Experimental	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) . Receives: Biological: 3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
18-26y (0,1,6m)	Experimental	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) . Receives: Biological: 3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7 months after the first dose

Secondary outcomes (6)

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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 8 month
Safety4: Pregnancy and pregnancy outcome.
Pregnancy and pregnancy outcome. To evaluate number of births and terminations between the different arms.
Measured: Up to 8 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 202131 Dec 2025

First posted24 Sep 2021
Study start19 Sep 2021
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical CancerStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,382 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05056402
Sponsor's protocol ID: HPV-PRO-012
Status last verified: Jul 2025
First submitted: 13 Sep 2021
Last updated: 22 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity Non-inferiority Immuno-bridging Study of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine (E.Coli) in Healthy Population Aged 9-17 Years Old vs Aged 18-26 Years Old
ClinicalTrials.gov ID: NCT05056402
Acronym / sponsor ID: HPV-PRO-012
Conditions: Cervical Cancer, Condylomata Acuminata
Keywords: human papillomavirus vaccine, immunogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 1,382 participants (actual)
Lead sponsor: Xiamen UniversityUniversity, hospital or other
Collaborators: Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Study start: 19 Sep 2021 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 24 Sep 2021 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
9-17y (0,6m)	Experimental	Biological: 2 doses of theRecombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)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) .
9-17y (0,1,6m)	Experimental	Biological: 3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)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) .
18-26y (0,1,6m)	Experimental	Biological: 3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)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) .

Who may qualify

Ages: 9 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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);

Key exclusion criteria (15 listed)

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.

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
3 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.	Biological	18-26y (0,1,6m), 9-17y (0,1,6m)
2 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.	Biological	9-17y (0,6m)

Primary outcome

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
Time frame: 7 months after the first dose
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.

6 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
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
Time frame: 30 months after the first dose
Safety1: 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.
Time frame: Within 30 days (Day 0-30) after any vaccination
Safety3: Severe adverse events occurred throughout the study.
Time frame: Up to 8 month
Safety4: Pregnancy and pregnancy outcome.
Time frame: Up to 8 month

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 22 Jul 2025.

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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.

Jun Zhang, master study chair

Xiamen University

Xue-cheng Liu, master principal investigator

Sichuan Provincial Centre 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?

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 15 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 22 Jul 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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 (time frame: 7 months after the first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05056402.

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 22 Jul 2025.