Cervical Intraepithelial NeoplasiaPhase 3NCT04537156

Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

A Phase 3 study testing Nonavalent HPV vaccine and Bivalent HPV vaccine in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Xiamen University at 2 sites 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 phase III clinical study was designed to evaluate the efficacy,immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women aged 18-45 years old. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Intraepithelial Neoplasia, Cervical Cancer, Condylomata Acuminata
What is being tested?: Nonavalent HPV vaccine and Bivalent HPV vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9,327 participants
Where: 2 sitesChina
Study dates: 5 Sep 2020to 31 Dec 2027
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 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Female aged between 18 and 45 years at the first vaccination;
Be able to understand and comply with the request of the protocol(e.g. biological specimen collection, diary card entry and attend regular follow-up), and sign written informed consent;
Women who agree to use effective contraception within 8 months after the first vaccination, or women who have undergone tubal ligation, benign subtotal hysterectomy, benign ovarian tumor removal, or postmenopausal women;
The number of sexual partners so far less than four;
Have intact cervix and have no history of physical or surgical treatment;
No previous history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, venereal lymphogranuloma, groin granuloma, etc.);
No previous history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN), and no abnormality in gynecological examination;
Sexual intercourse has occurred.

Who cannot join

Participants with acute cervicitis and acute lower genital tract infection, or with obvious condyloma;
Participants during menstruation, or have vaginal medication, sexual behavior (including anal, vaginal or external genital contact, regardless of the sex of parterner) within two days (48 hours) before the visit, which may affect gynecological examinations and specimens collection.
Axillary temperature > 37.0℃;
Participants who have positive urine pregnancy test, or are pregnant or breastfeeding;
Have used other investigational or unregistered products (drugs or vaccines) within 30 days before receiving the research vaccine or have participated in another clinical research in the past two years, or plan to use other research or unregistered products or participate in other research during the research period;
Long-term use (more than 14 continuous days) of immunosuppressors and other Immunoregulatory agents or systemic corticosteroids (Except intranasal steroid, the use of low dose topical, ophthalmic and inhaled steroid preparations will be permitted.) 6 months prior to vaccination.

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Administration of immunoglobulin and/or blood products 3 months prior to vaccination or intending to use them during the study.
Administration of inactivated vaccine within 14 days before 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 (Anti-flu agents include but are not limited to Tamiflu, Tamiflu, Symmetrel and Flumadine) 5 days prior to vaccination.
Have received other HPV vaccines or participated in clinical research related to HPV or cervical cancer previously;
Immunodeficiency disease, primary disease of important viscera, cancer and autoimmune disease (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy due to any condition, and other autoimmune 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 vaccines, or allergy to any of the components of investigational vaccine.
Asthma, which has been unstable for the past two years and requires emergency treatment, hospitalization, oral or intravenous corticosteroids;
Suffered from a serious medical illness;
Self-report past 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 did not require treatment in the past 3 years;
According to the judgement of investigator, various medical, psychological, social, vocational or other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Sichuan Provincial Centre for Disease Control and Prevention
Chengdu, Sichuan, 610041
Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Controlled (Bivalent Human Papillomavirus Vaccine (16,18 Type)(E. Coli)) Phase III Clinical Trial to Estimate Efficacy, Immunogenicity and Safty of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Women Aged 18 to 45 Years

Conditions: Cervical Intraepithelial Neoplasia, Cervical Cancer, Condylomata Acuminata
Being tested: Nonavalent HPV vaccine, Bivalent HPV vaccine
Keywords: human papillomavirus vaccine, cervical cancer, cervical intraepithelial neoplasia, condylomata acuminata
Medical subject headings: Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Condylomata Acuminata

What participants receive

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

Nonavalent HPV vaccineBiological
Nonavalent HPV vaccine (270μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Bivalent HPV vaccineBiological
Bivalent HPV vaccine (60μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Study groups in NCT04537156
Study group	Role	What they receive
HPV vaccine (6,11,16,18,31,33,45,52,58 Types)	Experimental	Participants in this arm would receive 270μg/0.5ml HPV vaccines (6,11,16,18,31,33,45,52,58 Types). Receives: Biological: Nonavalent HPV vaccine
HPV vaccine (16,18 Types)	Active comparator	Participants in this arm would receive 60μg/0.5ml HPV vaccines (16,18 Types). Receives: Biological: Bivalent HPV vaccine

What is being measured

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

Non-inferiority of anti-HPV 16 and 18 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody) in the PPS-I set
Detect the level of anti-HPV 16 and 18 specific neutralizing antibodies at one month after the third dose to determine whether nine-valent HPV vaccine is non-inferior to the control bivalent HPV vaccine
Measured: Specific neutralizing antibodies at 7 months after first dose
Persistent infection of HPV31, 33, 45, 52 and 58 (over 12 months) (Combined analysis of the 5 types) in the mITT-PI set
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine
Measured: Cumulative incidence of this endpoint events in 78 months after the first dose
Incidence of CIN2 + and/or VIN2 + and/or VaIN2 + lesions related to HPV 31, 33, 45, 52 or 58 (Combined analysis of the 5 types) in the mITT-E when the first two endpoints are satisfied
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine
Measured: Cumulative incidence of this endpoint events in 78 months after the first dose

Secondary outcomes (16)

Efficacy1: Incidence of CIN2 + and/or VIN2 + and/or VaIN2 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types) and genital warts related to HPV 6, 11 (Combined analysis of each type)
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine
Measured: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy2: Incidence of CIN1 + and/or VIN1 + and/or VaIN1 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types) and genital warts related to HPV 6, 11 (Combined analysis of each type)
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine
Measured: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy3: Incidence of Persistent infection of HPV31, 33, 45, 52 and 58 (transient infection and over 6 months) (Combined analysis of the 5 types)
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine
Measured: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy4: Incidence of CIN1 + and/or VIN1 + and/or VaIN1 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types)
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine
Measured: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy5: Incidence of Persistent infection of HPV31, 33, 45, 52 and 58 (over 6 months) and/or incidence of CIN1 + and/or VIN1 + and/or VaIN1 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types)
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine
Measured: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy6: Incidence of genital warts related to HPV 6, 11
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine
Measured: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy7: Incidence of Persistent infection of HPV31, 33, 45, 52, 58, 6 and 11 (transient infection and over 6 months and over 12 months) (Combined analysis of the 7 types)
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine
Measured: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy8: Incidence of Persistent infection of HPV31, 33, 45, 52, 58, 6 and 11 (over 6 months and over 12 months) (Independent analysis of each type)
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine
Measured: Cumulative incidence of this endpoint events in 78 months after the first dose
Immunogenicity1: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7
Analysis the seroconversion and geometric mean concertration of the type specific antibodies of the 7 types.
Measured: Month 7 after first vaccination
Immunogenicity2: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 18 and 30
Analysis the seroconversion and geometric mean concertration of the type specific antibodies of the 7 types.
Measured: Month 18 and 30 after first vaccination
Immunogenicity3: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 42, 54, 66 and 78
Analysis the seroconversion and geometric mean concertration of the type specific antibodies of the 7 types.
Measured: Month 42, 54, 66 and 78 after first vaccination
Safety1: Local and systematic adverse events/reactions occurred within 7 days after each vaccination
safety analysis
Measured: During the 7-day (Day 0-6) period following each vaccination
Safety2: Adverse events/reactions occurred within 30 days after each vaccination
safety analysis
Measured: Within 30 days (Day 0-30) after any vaccination
Safety3: Serious adverse events occurred throughout the study
safety analysis. To evaluate number of SAEs compared with the control vaccine.
Measured: Up to 78 month
Safety4: Pregnancy and pregnancy outcome
safety analysis. To evaluate number of births and terminations compared with the control vaccine.
Measured: Up to 78 month
Safety5: New-onset acute and chronic diseases (especially autoimmune diseases)
safety analysis.To evaluate number of new-onset acute and chronic diseases (especially new-onset autoimmune diseases) throughout the study.
Measured: Up to 78 month

Timeline

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

5 Sep 202031 Dec 2027

First posted3 Sep 2020
Study start5 Sep 2020
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cervical Intraepithelial NeoplasiaStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 9,327 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04537156
Sponsor's protocol ID: HPV-PRO-009
Status last verified: Feb 2025
First submitted: 19 Aug 2020
Last updated: 21 Nov 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Pan HX, Bi ZF, Jing YL, Hu SY, Zhang L, Zhu KX, Chu K, Hong Y, Chang SF, Pan QJ, Zhang X, Xu JB, Tang J, Yuan DY, Jiang H, Du C, Sun G, Zhong GH, Chen Q, Wei LH, Qiao YL, Li SW, Su YY, Zhang QF, Huang SJ, Zhao FH, Huang WJ, Wu T, Zhang J, Xia NS. Efficacy, safety, and immunogenicity of an Escherichia coli-produced nine-valent human papillomavirus vaccine: a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Infect Dis. 2026 Jun 30:S1473-3099(26)00221-5. doi: 10.1016/S1473-3099(26)00221-5. Online ahead of print.
PubMed 42379209

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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Controlled (Bivalent Human Papillomavirus Vaccine (16,18 Type)(E. Coli)) Phase III Clinical Trial to Estimate Efficacy, Immunogenicity and Safty of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Women Aged 18 to 45 Years
ClinicalTrials.gov ID: NCT04537156
Acronym / sponsor ID: HPV-PRO-009
Conditions: Cervical Intraepithelial Neoplasia, Cervical Cancer, Condylomata Acuminata
Keywords: human papillomavirus vaccine, cervical cancer, cervical intraepithelial neoplasia, condylomata acuminata
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 9,327 participants (actual)
Lead sponsor: Xiamen UniversityUniversity, hospital or other
Collaborators: Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Study start: 5 Sep 2020 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 3 Sep 2020 (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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HPV vaccine (6,11,16,18,31,33,45,52,58 Types)	Experimental	Biological: Nonavalent HPV vaccineParticipants in this arm would receive 270μg/0.5ml HPV vaccines (6,11,16,18,31,33,45,52,58 Types).
HPV vaccine (16,18 Types)	Active comparator	Biological: Bivalent HPV vaccineParticipants in this arm would receive 60μg/0.5ml HPV vaccines (16,18 Types).

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Female aged between 18 and 45 years at the first vaccination;
Be able to understand and comply with the request of the protocol(e.g. biological specimen collection, diary card entry and attend regular follow-up), and sign written informed consent;
Women who agree to use effective contraception within 8 months after the first vaccination, or women who have undergone tubal ligation, benign subtotal hysterectomy, benign ovarian tumor removal, or postmenopausal women;
The number of sexual partners so far less than four;
Have intact cervix and have no history of physical or surgical treatment;

Key exclusion criteria (17 listed)

Participants with acute cervicitis and acute lower genital tract infection, or with obvious condyloma;
Participants during menstruation, or have vaginal medication, sexual behavior (including anal, vaginal or external genital contact, regardless of the sex of parterner) within two days (48 hours) before the visit, which may affect gynecological examinations and specimens collection.
Axillary temperature > 37.0℃;
Participants who have positive urine pregnancy test, or are pregnant or breastfeeding;
Have used other investigational or unregistered products (drugs or vaccines) within 30 days before receiving the research vaccine or have participated in another clinical research in the past two years, or plan to use other research or unregistered products or participate in other research during the research period;

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
Nonavalent HPV vaccineNonavalent HPV vaccine (270μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.	Biological	HPV vaccine (6,11,16,18,31,33,45,52,58 Types)
Bivalent HPV vaccineBivalent HPV vaccine (60μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.	Biological	HPV vaccine (16,18 Types)

Primary outcome

Non-inferiority of anti-HPV 16 and 18 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody) in the PPS-I set
Time frame: Specific neutralizing antibodies at 7 months after first dose
Detect the level of anti-HPV 16 and 18 specific neutralizing antibodies at one month after the third dose to determine whether nine-valent HPV vaccine is non-inferior to the control bivalent HPV vaccine
Persistent infection of HPV31, 33, 45, 52 and 58 (over 12 months) (Combined analysis of the 5 types) in the mITT-PI set
Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine
Incidence of CIN2 + and/or VIN2 + and/or VaIN2 + lesions related to HPV 31, 33, 45, 52 or 58 (Combined analysis of the 5 types) in the mITT-E when the first two endpoints are satisfied
Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose
To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine

16 secondary outcomes

Efficacy1: Incidence of CIN2 + and/or VIN2 + and/or VaIN2 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types) and genital warts related to HPV 6, 11 (Combined analysis of each type)
Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy2: Incidence of CIN1 + and/or VIN1 + and/or VaIN1 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types) and genital warts related to HPV 6, 11 (Combined analysis of each type)
Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy3: Incidence of Persistent infection of HPV31, 33, 45, 52 and 58 (transient infection and over 6 months) (Combined analysis of the 5 types)
Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy4: Incidence of CIN1 + and/or VIN1 + and/or VaIN1 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types)
Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy5: Incidence of Persistent infection of HPV31, 33, 45, 52 and 58 (over 6 months) and/or incidence of CIN1 + and/or VIN1 + and/or VaIN1 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types)
Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy6: Incidence of genital warts related to HPV 6, 11
Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy7: Incidence of Persistent infection of HPV31, 33, 45, 52, 58, 6 and 11 (transient infection and over 6 months and over 12 months) (Combined analysis of the 7 types)
Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose
Efficacy8: Incidence of Persistent infection of HPV31, 33, 45, 52, 58, 6 and 11 (over 6 months and over 12 months) (Independent analysis of each type)
Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose
Immunogenicity1: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7
Time frame: Month 7 after first vaccination
Immunogenicity2: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 18 and 30
Time frame: Month 18 and 30 after first vaccination
Immunogenicity3: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 42, 54, 66 and 78
Time frame: Month 42, 54, 66 and 78 after first vaccination
Safety1: Local and systematic adverse events/reactions occurred within 7 days after each vaccination
Time frame: During the 7-day (Day 0-6) 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: Serious adverse events occurred throughout the study
Time frame: Up to 78 month
Safety4: Pregnancy and pregnancy outcome
Time frame: Up to 78 month
Safety5: New-onset acute and chronic diseases (especially autoimmune diseases)
Time frame: Up to 78 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 21 Nov 2025.
Derived from this study: PubMed 42379209Pan HX, Bi ZF, Jing YL, Hu SY, Zhang L, Zhu KX, Chu K, Hong Y, Chang SF, Pan QJ, Zhang X, Xu JB, Tang J, Yuan DY, Jiang H, Du C, Sun G, Zhong GH, Chen Q, Wei LH, Qiao YL, Li SW, Su YY, Zhang QF, Huang SJ, Zhao FH, Huang WJ, Wu T, Zhang J, Xia NS. Efficacy, safety, and immunogenicity of an Escherichia coli-produced nine-valent human papillomavirus vaccine: a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Infect Dis. 2026 Jun 30:S1473-3099(26)00221-5. doi: 10.1016/S1473-3099(26)00221-5. Online ahead of print.

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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

Hong-xing Pan, master principal investigator

Jiangsu Provincial Centre for Disease Control and Prevention

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nonavalent HPV vaccine and Bivalent HPV vaccine in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Xiamen University at 2 sites 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 8 inclusion and 17 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Non-inferiority of anti-HPV 16 and 18 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody) in the PPS-I set (time frame: Specific neutralizing antibodies at 7 months after first dose). The study lists 3 primary outcomes in all. 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 NCT04537156, which also lists 1 linked publication.

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 21 Nov 2025.