Human Papillomavirus (HPV) InfectionPhase 3NCT06632912
Phase IIIb Clinical Trial of Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) for Age/Immunization Schedule Bridging
A Phase 3 study testing 2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) and 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in people with Human Papillomavirus (HPV) Infection and HPV (Human Papillomavirus)-Associated Carcinoma, run by National Vaccine and Serum Institute, China at 3 sites in China.
Trial summary
This vaccine was jointly developed by Chengdu Institute of Biological Products Co., Ltd. and National Vaccine and Serum Institute, China, is co-sponsoring this clinical trial. This trial plans to enroll 1,800 female subjects aged 9-35 years, 450 in each of the 18-25 years old 3-dose group, 26-35 years old 3-dose… Read more about this study
- Who is it for?
- Ages 9 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus (HPV) Infection, HPV (Human Papillomavirus)-Associated Carcinoma
- What is being tested?
- 2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) and 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 3 sitesChina
- Study dates
- 21 Nov 2025to Jul 2032
- 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 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Females aged 9-35 years at the time of enrollment;
- Subjects aged 9-17 years at the time of enrollment and at least one legal guardian are informed and willing to participate, sign the informed consent form and can provide valid identity documents; subjects aged 18-35 years at the time of enrollment are informed and willing to participate, sign the informed consent form and can provide valid identity documents;
- Subjects are able to understand the research procedures and cooperate with the requirements of the clinical trial to participate in regular follow-up;
- Female subjects of childbearing age have a negative urine pregnancy test on the day of enrollment, are not breastfeeding and have no fertility plans within 7 months after enrollment; have taken effective contraceptive measures since the end of the last menstruation until enrollment, and agree to continue to use effective contraceptive measures within 7 months after participating in the study (effective contraceptive measures include: oral contraceptives, injections or implants, sustained-release local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.);
- Body temperature ≤37.0℃ (axillary temperature) on the day of enrollment.
Who cannot join
- First dose exclusion criteria
- Those who have received a commercially available HPV vaccine in the past or plan to receive a commercially available HPV vaccine during the study; or have participated in other HPV vaccine clinical trials and have received the vaccine/placebo;
- Those who have a history of cervical lesions that are likely to be related to HPV infection (such as abnormal cervical cancer screening, CIN disease history); Those who have a history of hysterectomy or pelvic radiotherapy; Patients who have a history of external genital diseases that are likely to be related to HPV infection (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, and genital warts);
- Those who have a history of severe allergic reactions to any vaccine or drug (including yeast) that require medical intervention, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.Or individuals with a known hypersensitivity to any of the components of the test vaccine (L-histidine, sodium chloride, aluminum hydroxide, and water for injection);
- Those who have impaired immune function or have been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (Human Immunodeficiency Virus). Virus, HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;
- Those who have received long-term (≥14 days) immunomodulatory therapy (including immune enhancers and immunosuppressants) within 1 year prior to vaccination or within 7 months after enrollment, such as oral or injectable systemic glucocorticoid therapy (≥14 days, dose ≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent prednisone dose), are permitted to use topical medications (such as ointments, eye drops, inhalers or nasal sprays), but topical medications must not exceed the dose recommended in the instructions or have any signs of systemic exposure;
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- Any immunoglobulin or blood products within 3 months before vaccination or planned within 7 months after enrollment;
- Those who have received a non-live vaccine within 14 days prior to vaccination, or a live vaccine within 28 days prior to vaccination;
- Acute onset or use of antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination, or acute attack of chronic diseases;
- History of convulsions (except febrile convulsions), or history or family history of epilepsy, encephalopathy, mental illness;
- Past or current severe (such as emergency treatment, surgical treatment, etc.) heart disease (such as congenital heart disease, etc.), liver and kidney disease (such as chronic hepatitis or suspected active hepatitis, nephrotic syndrome, uremia, etc.), complications of diabetes, malignant tumors, etc.;
- Elevated blood pressure measured by on-site physical examination (9-15 years old: systolic blood pressure ≥100+1.5×age (years) mmHg and/or diastolic blood pressure ≥65+age (years) mmHg; 16-26 years old: systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg);
- Participating in clinical studies of other investigational or unmarketed products (drugs, vaccines and medical devices) within 3 months before vaccination or planning to participate in the study period;
- Asplenia or functional asplenia, or splenectomy caused by any circumstances;
- Suffering from thrombocytopenia or other coagulation disorders that may be contraindications to intramuscular injection;
- Any other factors that the researcher believes make the subject unsuitable for participation in clinical trials.
- Subsequent doses of vaccination should be postponed if any of the following conditions occur. Delays should ideally be made within the prescribed time window:
- Axillary temperature >37.0℃ before vaccination;
- Received any immunoglobulin or blood products within 3 months prior to vaccination;
- Received a non-live vaccine within 14 days prior to vaccination, or a live vaccine within 28 days prior to vaccination;
- Acute onset of illness or use of antipyretics, analgesics, and antihistamines (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days prior to vaccination, or an acute exacerbation of a chronic disease;
- Any other reason deemed necessary for postponement by the investigator.
- If any of the following situations occur, the researcher will terminate the subsequent doses of vaccination for the subject.
- Positive urine pregnancy test before vaccination (on the day of vaccination); Note: If the subject chooses to terminate the pregnancy, at least 6 weeks after the end of the pregnancy and can submit medical evidence of termination of pregnancy (such as imaging reports or relevant medical records, etc.), the researcher can continue to vaccinate if it is considered that the subject can continue to vaccinate; if the subject chooses to continue the pregnancy, the subsequent doses of vaccination will not be administered.
- Newly discovered or newly occurring situations that meet the first dose exclusion criteria 1, 2, 3, 4, 9, 10, 13, and 14;
- After vaccination, adverse reactions related to vaccination are evaluated and considered unsuitable for continued vaccination;
- Any other reasons that the researcher assesses to terminate vaccination.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shanxian Center for Disease Control and Prevention
Heze, Shandong
Liaocheng Center for Disease Control and Prevention
Liaocheng, Shandong
Daiyue District Center for Disease Control and Prevention
Tai’an, Shandong
About this study
Official title: A Randomized, Open-label, Non-inferiority Phase IIIb Clinical Trial to Evaluate the Immunogenicity Age/Schedule Bridging Between Adolescent Girls Aged 9-14 Years Receiving a 2-dose Regimen or Adolescent Girls Aged 9-17 Years Receiving a 3-dose Regimen of a Quadrivalent Recombinant Human Papillomavirus (HPV) Vaccine (Hansenula Polymorpha) and Women Aged 18-35 Years.
This vaccine was jointly developed by Chengdu Institute of Biological Products Co., Ltd. and National Vaccine and Serum Institute, China, is co-sponsoring this clinical trial.
This trial plans to enroll 1,800 female subjects aged 9-35 years, 450 in each of the 18-25 years old 3-dose group, 26-35 years old 3-dose group, 9-17 years old 3-dose group and 9-14 years old 2-dose group.
All subjects in the 9-14 years old 2-dose group will be injected with 2 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0-6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 6 on-site visits and subjects in the immune persistence subgroup will need to complete 13 on-site visits ; All subjects in the 9-17 years old 3-dose group and the 18-35 years old 3-dose group will be injected with 3 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0, 2, and 6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 9 on-site visits and subjects in the immune persistence subgroup will need to complete 16 on-site visits
- Being tested
- 2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha), 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)
- Keywords
- hpv, hpv vaccine
- Medical subject headings
- Papillomavirus Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)Biological
Two doses of the experimental vaccine were injected into the deltoid muscle of the upper arm according to the immunization schedule at 0 and 6 months.
3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)Biological
Three doses of the experimental vaccine were injected into the deltoid muscle of the upper arm according to the immunization schedule at 0, 2, and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 18-25 years old 3 doses group | Experimental | Not described Receives: Biological: 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) |
| 9-17 years old 3 doses group | Experimental | Not described Receives: Biological: 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) |
| 9-14 years old 2 doses group | Experimental | Not described Receives: Biological: 2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) |
| 26-35 years old 3 doses group | Experimental | Not described Receives: Biological: 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among subjects who were seronegative at baseline (pre-vaccination)
Measured: 1 month after completion of the vaccination series
Secondary outcomes (18)
Proportion of subjects with a ≥4-fold rise in neutralizing antibody titers against HPV types 6, 11, 16, and 18 among subjects who were seronegative at baseline (pre-vaccination)
Measured: 1 month after completion of the vaccination series
Geometric mean fold rise (GMFR) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among participants who were seronegative at baseline (pre-vaccination)
Measured: 1 month after completion of the vaccination series
Geometric Mean Titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 at 1 month after completion of the vaccination series among participants who were seropositive at baseline (pre-vaccination).
Measured: 1 month after completion of the vaccination series
Geometric mean fold rise (GMFR) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among participants who were seropositive at baseline (pre-vaccination)
Measured: 1 month after completion of the vaccination series
Proportion of participants with a ≥4-fold rise in neutralizing antibody titers to HPV types 6, 11, 16, and 18 among participants who were seropositive at baseline (pre-vaccination)
Measured: 1 month after completion of the vaccination series
Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Measured: 1 month after completion of the vaccination series
Geometric mean fold rise (GMFR) of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Measured: 1 month after completion of the vaccination series
Proportion of subjects with a ≥4-fold rise in neutralizing antibody titers against HPV types 6, 11, 16, and 18 in all subjects
Measured: 1 month after completion of the vaccination series
Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Measured: 6, 12, 24, 36, 48, 60, and 72 months after completion of the vaccination series
Seropositivity rate of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Measured: 6, 12, 24, 36, 48, 60, and 72 months after completion of the vaccination series
The number of cases of AE（Adverse Event）
Measured: From the first vaccination through 1 month after completion of the vaccination series
The incidence of AEs leading to subjects withdrawing from clinical trials
Measured: From the first vaccination through 1 month after completion of the vaccination series
Distribution of severity of AE
Measured: From the first vaccination through 1 month after completion of the vaccination series
The incidence of AEs
Measured: Within 0-30 days after each vaccination (including 30 minutes, 0-7 days, and 8-30 days) and >30 days after each vaccination
Distribution of severity of AE
Measured: Within 0-30 days after each vaccination (including 30 minutes, 0-7 days, and 8-30 days) and >30 days after each vaccination
The incidence of SAE
Measured: From the first vaccination through 6 months after completion of the vaccination series
Collect information about previous pregnancies of pregnant women survey
Such as previous pregnancy, current pregnancy mode, etc
Measured: From the first vaccination through the end of the study（Approximately 72 months）
Obtain pregnancy outcomes in pregnant subjects survey
Collecting newborn information
Measured: From the first vaccination through the end of the study（Approximately 72 months）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start21 Nov 2025
- Primary completionJul 2032 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus (HPV) InfectionStudies 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
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Vaccine and Serum Institute, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chengdu Institute of Biological Products Co.,Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632912
- Sponsor's protocol ID
- CNBG-CD-022-CT-4-Ⅲb
- Status last verified
- Jan 2026
- First submitted
- 8 Oct 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Non-inferiority Phase IIIb Clinical Trial to Evaluate the Immunogenicity Age/Schedule Bridging Between Adolescent Girls Aged 9-14 Years Receiving a 2-dose Regimen or Adolescent Girls Aged 9-17 Years Receiving a 3-dose Regimen of a Quadrivalent Recombinant Human Papillomavirus (HPV) Vaccine (Hansenula Polymorpha) and Women Aged 18-35 Years.
- ClinicalTrials.gov ID
- NCT06632912
- Acronym / sponsor ID
- CNBG-CD-022-CT-4-Ⅲb
- Keywords
- hpv, hpv vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- National Vaccine and Serum Institute, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Chengdu Institute of Biological Products Co.,Ltd.
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- Jul 2032 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 9 Oct 2024 (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.
This vaccine was jointly developed by Chengdu Institute of Biological Products Co., Ltd. and National Vaccine and Serum Institute, China, is co-sponsoring this clinical trial.
This trial plans to enroll 1,800 female subjects aged 9-35 years, 450 in each of the 18-25 years old 3-dose group, 26-35 years old 3-dose group, 9-17 years old 3-dose group and 9-14 years old 2-dose group.
All subjects in the 9-14 years old 2-dose group will be injected with 2 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0-6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 6 on-site visits and subjects in the immune persistence subgroup will need to complete 13 on-site visits ; All subjects in the 9-17 years old 3-dose group and the 18-35 years old 3-dose group will be injected with 3 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0, 2, and 6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 9 on-site visits and subjects in the immune persistence subgroup will need to complete 16 on-site visits
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 18-25 years old 3 doses group | Experimental | Biological: 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) |
| 9-17 years old 3 doses group | Experimental | Biological: 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) |
| 9-14 years old 2 doses group | Experimental | Biological: 2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) |
| 26-35 years old 3 doses group | Experimental | Biological: 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) |
Who may qualify
- Ages
- 9 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Females aged 9-35 years at the time of enrollment;
- Subjects aged 9-17 years at the time of enrollment and at least one legal guardian are informed and willing to participate, sign the informed consent form and can provide valid identity documents; subjects aged 18-35 years at the time of enrollment are informed and willing to participate, sign the informed consent form and can provide valid identity documents;
- Subjects are able to understand the research procedures and cooperate with the requirements of the clinical trial to participate in regular follow-up;
- Female subjects of childbearing age have a negative urine pregnancy test on the day of enrollment, are not breastfeeding and have no fertility plans within 7 months after enrollment; have taken effective contraceptive measures since the end of the last menstruation until enrollment, and agree to continue to use effective contraceptive measures within 7 months after participating in the study (effective contraceptive measures include: oral contraceptives, injections or implants, sustained-release local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.);
- Body temperature ≤37.0℃ (axillary temperature) on the day of enrollment.
Key exclusion criteria (27 listed)
- First dose exclusion criteria
- Those who have received a commercially available HPV vaccine in the past or plan to receive a commercially available HPV vaccine during the study; or have participated in other HPV vaccine clinical trials and have received the vaccine/placebo;
- Those who have a history of cervical lesions that are likely to be related to HPV infection (such as abnormal cervical cancer screening, CIN disease history); Those who have a history of hysterectomy or pelvic radiotherapy; Patients who have a history of external genital diseases that are likely to be related to HPV infection (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, and genital warts);
- Those who have a history of severe allergic reactions to any vaccine or drug (including yeast) that require medical intervention, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.Or individuals with a known hypersensitivity to any of the components of the test vaccine (L-histidine, sodium chloride, aluminum hydroxide, and water for injection);
- Those who have impaired immune function or have been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (Human Immunodeficiency Virus). Virus, HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;
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 |
|---|---|---|
| 2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)Two doses of the experimental vaccine were injected into the deltoid muscle of the upper arm according to the immunization schedule at 0 and 6 months. | Biological | 9-14 years old 2 doses group |
| 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)Three doses of the experimental vaccine were injected into the deltoid muscle of the upper arm according to the immunization schedule at 0, 2, and 6 months. | Biological | 18-25 years old 3 doses group, 26-35 years old 3 doses group, 9-17 years old 3 doses group |
Primary outcome
Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among subjects who were seronegative at baseline (pre-vaccination)
Time frame: 1 month after completion of the vaccination series
18 secondary outcomes
Proportion of subjects with a ≥4-fold rise in neutralizing antibody titers against HPV types 6, 11, 16, and 18 among subjects who were seronegative at baseline (pre-vaccination)
Time frame: 1 month after completion of the vaccination series
Geometric mean fold rise (GMFR) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among participants who were seronegative at baseline (pre-vaccination)
Time frame: 1 month after completion of the vaccination series
Geometric Mean Titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 at 1 month after completion of the vaccination series among participants who were seropositive at baseline (pre-vaccination).
Time frame: 1 month after completion of the vaccination series
Geometric mean fold rise (GMFR) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among participants who were seropositive at baseline (pre-vaccination)
Time frame: 1 month after completion of the vaccination series
Proportion of participants with a ≥4-fold rise in neutralizing antibody titers to HPV types 6, 11, 16, and 18 among participants who were seropositive at baseline (pre-vaccination)
Time frame: 1 month after completion of the vaccination series
Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Time frame: 1 month after completion of the vaccination series
Geometric mean fold rise (GMFR) of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Time frame: 1 month after completion of the vaccination series
Proportion of subjects with a ≥4-fold rise in neutralizing antibody titers against HPV types 6, 11, 16, and 18 in all subjects
Time frame: 1 month after completion of the vaccination series
Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Time frame: 6, 12, 24, 36, 48, 60, and 72 months after completion of the vaccination series
Seropositivity rate of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects
Time frame: 6, 12, 24, 36, 48, 60, and 72 months after completion of the vaccination series
The number of cases of AE（Adverse Event）
Time frame: From the first vaccination through 1 month after completion of the vaccination series
The incidence of AEs leading to subjects withdrawing from clinical trials
Time frame: From the first vaccination through 1 month after completion of the vaccination series
Distribution of severity of AE
Time frame: From the first vaccination through 1 month after completion of the vaccination series
The incidence of AEs
Time frame: Within 0-30 days after each vaccination (including 30 minutes, 0-7 days, and 8-30 days) and >30 days after each vaccination
Distribution of severity of AE
Time frame: Within 0-30 days after each vaccination (including 30 minutes, 0-7 days, and 8-30 days) and >30 days after each vaccination
The incidence of SAE
Time frame: From the first vaccination through 6 months after completion of the vaccination series
Collect information about previous pregnancies of pregnant women survey
Time frame: From the first vaccination through the end of the study（Approximately 72 months）
Obtain pregnancy outcomes in pregnant subjects survey
Time frame: From the first vaccination through the end of the study（Approximately 72 months）
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 23 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) and 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in people with Human Papillomavirus (HPV) Infection and HPV (Human Papillomavirus)-Associated Carcinoma, run by National Vaccine and Serum Institute, China at 3 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 5 inclusion and 27 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 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among subjects who were seronegative at baseline (pre-vaccination) (time frame: 1 month after completion of the vaccination series). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2026.