HPV InfectionsPhase 3NCT05027776
Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years
A Phase 3 study testing 2-doses Group among 9-14 years, 3-doses Group among 9-19 years and 3-doses Group among 20-26 years in people with HPV Infections and Cervical Cancer Stage IIa, run by Shanghai Bovax Biotechnology Co., Ltd. at 1 site in China.
Trial summary
This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years Read more about this study
- Who is it for?
- Ages 9 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infections, Cervical Cancer Stage IIa, Vaginal Cancer
- What is being tested?
- 2-doses Group among 9-14 years, 3-doses Group among 9-19 years and 3-doses Group among 20-26 years
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,348 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2021to 29 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy Chinese females aged 9 to 26 years; Provide legal identification;
- The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
- Had a negative urine pregnancy test on the day of enrollment, among the subjects of childbearing age; Not in the duration of breast-feeding and no birth plan within 7 months; According to the investigator's judgment that there is no possibility of pregnancy at that time: subjects have taken effective contraception, or asexual life after the last menstrual period, or use IUD, or had undergone ligation; subjects agree to continue take effective contraception such as taking OCS and condom use;
- No fever symptoms on the day of enrollment (aged> 14 years old, axillary temperature<37.3°C; aged ≤ 14 years old, axillary temperature<37.5°C );
- Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements;
Who cannot join
- Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials;
- Enrolling or plan to enroll in other clinical trials (drug or vaccine);
- History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, LSIL, and cervical cancer) or history of pelvic radiotherapyherpes;
- History of diseases related to HPV infection (e.g. genital warts, VIN, VaIN, and related cancers) or history of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc.;
- Known allergy to any vaccine components or history of severe allergic diseases requiring treatment, including shock, laryngeal edema, urticarial, Henoch-Schonlein purpura, Arthus reaction, etc.;
- Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc;
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- History of epilepsy and convulsions (except fever convulsions in children under 5 years of age);
- Subjects with existing infectious diseases such as TB, viral hepatitis, and/or HIV infection; or existing liver or kidney conditions, CVDs, and malignancy;
- Untreated/uncontrolled hypertension before vaccination (aged 9 to 17 years: systolic BP≥120mmHg and/or diastolic BP≥80mmHg; aged more than 18 years: Systolic BP≥140mmHg and/or diastolic BP ≥90mmHg);
- With prohibitive contraindications such as Thrombocytopenia or coagulopathy;
- Asplenic, functionally asplenic, or splenectomy caused by any condition;
- Received immunosuppressive treatment within one month before study such as long-term glucocorticoid use(≥2mg per kg per day, lasted more than two wks), or plan to receive such treatment from month 0 to month 7；
- Receipt of immune globulin or blood-related products within 3 months; or plan to receive such products during this study period（month 0 to month 7）;
- Within 3 days prior to vaccination, have an acute disease or are in the acute attack of a chronic disease or have used antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, loratadine, ceti Rizine, etc.);
- Receipt of inactivated, RNA, and recombinant vaccines within 14 days, live vaccines within 28 days;
- Subjects with existing mental illness, History of mental illness, or Family History;
- According to the investigator's judgment, the subject has any condition may interfere with process of evaluation or participating in this study cannot guarantee the object's maximum benefit.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Center for Disease Control and Prevention
Mianyang, Sichuan
Quanyou Liu, +8613608120046, 767573156@qq.com
About this study
Official title: Evaluating the Immunogenicity and Safety of Quadrivalent Human Papillomavirus Recombinant Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 26 Years: A Phase 3, Open-label, Non-randomized Clinical Trial
This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years
Read the detailed description
This is a singel-center study (protocol 4-HPV-3002) in which women are planned to receive q-HPV vaccine. Study participation will last approximately 60 months and involves a total of nine or eleven scheduled visits.
This study will also assess whether the immunogenicity of the q-HPV vaccine given 2-dose schedule in 9-14 year old girls is noninferior to that in young women, aged 20-26, receiving 3 doses, and 3 doses in 9-19 year old girls is noninferior to that in young women receiving 3 doses, while assessing the safety of this vaccine.
- Conditions
- HPV Infections, Cervical Cancer Stage IIa, Vaginal Cancer, Genital Wart, CIN1, CIN2
- Being tested
- 2-doses Group among 9-14 years, 3-doses Group among 9-19 years, 3-doses Group among 20-26 years
- Keywords
- Human papillomavirus, vaccine, Cervical Cancer
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Vaginal Neoplasms, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-doses Group among 9-14 yearsBiological
Subjects were planned to receive two doses of the study vaccine administered intramuscularly according to a 0, 6 month vaccination schedule.
3-doses Group among 9-19 yearsBiological
Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
3-doses Group among 20-26 yearsBiological
Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 2-doses Group | Experimental | Subjects aged 9-14 years, received 2 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 6-month schedule. Receives: Biological: 2-doses Group among 9-14 years |
| Experimental: 3-doses Group | Experimental | Subjects aged 9-19 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule. Receives: Biological: 3-doses Group among 9-19 years |
| Acitve Group | Active comparator | Subjects aged 20-26 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule. Receives: Biological: 3-doses Group among 20-26 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary immunogenicity outcome
Number of subjects receiving the whole schedule vaccination with antibody responses as assessed by GMT and SCR, change from baseline among the seronegative vaccine recipients at Month 8
Measured: At month 8
Secondary outcomes (6)
Secondary immunogenicity outcome
TNumber of subjects, aged 9 to 14, receiving the 2-doses scheduled vaccination with antibody responses as assessed by GMT and SCR, change from baseline among the seronegative vaccine recipients at Month 12, 24, 36, 48 and 60
Measured: At month 12, 24, 36, 48 and 60
Number of subjecs with AEs
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.3°C or 37.5°C) and urticaria.
Measured: Within 30 minutes (Days 0) after vaccination
Numbers of subjects with solication of AEs
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.3°C or 37.5°C) and urticaria.
Measured: Within 8 days (Days 0-8) after vaccination
Numbers of subjects with unsolicited AEs
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: Within days 0-30 after vaccination
Number of subjects receiving the whole schedule vaccination with SAEs
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: Subjects receiving a 2-doses shceduled vaccination from Day o to Month 60; Subjects receiving a 3-doses shceduled vaccination from Day o to Month 12
Number of subjects with pregnancy events
Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA) , Live infant, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.
Measured: Subjects receiving a 2-doses shceduled vaccination from Day o to Month 60; Subjects receiving a 3-doses shceduled vaccination from Day o to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start15 Sep 2021
- Primary completion22 Nov 2023
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionsStudies 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
- 1,348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bovax Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chongqing Bovax Biopharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ting Huang, Study director, Sichuan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027776
- Sponsor's protocol ID
- 4-HPV-3002
- Status last verified
- Apr 2024
- First submitted
- 20 Aug 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Immunogenicity and Safety of Quadrivalent Human Papillomavirus Recombinant Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 26 Years: A Phase 3, Open-label, Non-randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05027776
- Acronym / sponsor ID
- 4-HPV-3002
- Conditions
- HPV Infections, Cervical Cancer Stage IIa, Vaginal Cancer, Genital Wart, CIN1, CIN2
- Keywords
- Human papillomavirus, vaccine, Cervical Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,348 participants (estimated)
- Lead sponsor
- Shanghai Bovax Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chongqing Bovax Biopharmaceutical Co., Ltd.
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 30 Aug 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.
This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years
Detailed description
This is a singel-center study (protocol 4-HPV-3002) in which women are planned to receive q-HPV vaccine. Study participation will last approximately 60 months and involves a total of nine or eleven scheduled visits.
This study will also assess whether the immunogenicity of the q-HPV vaccine given 2-dose schedule in 9-14 year old girls is noninferior to that in young women, aged 20-26, receiving 3 doses, and 3 doses in 9-19 year old girls is noninferior to that in young women receiving 3 doses, while assessing the safety of this vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: 2-doses Group | Experimental | Biological: 2-doses Group among 9-14 yearsSubjects aged 9-14 years, received 2 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 6-month schedule. |
| Experimental: 3-doses Group | Experimental | Biological: 3-doses Group among 9-19 yearsSubjects aged 9-19 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule. |
| Acitve Group | Active comparator | Biological: 3-doses Group among 20-26 yearsSubjects aged 20-26 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule. |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy Chinese females aged 9 to 26 years; Provide legal identification;
- The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
- Had a negative urine pregnancy test on the day of enrollment, among the subjects of childbearing age; Not in the duration of breast-feeding and no birth plan within 7 months; According to the investigator's judgment that there is no possibility of pregnancy at that time: subjects have taken effective contraception, or asexual life after the last menstrual period, or use IUD, or had undergone ligation; subjects agree to continue take effective contraception such as taking OCS and condom use;
- No fever symptoms on the day of enrollment (aged> 14 years old, axillary temperature<37.3°C; aged ≤ 14 years old, axillary temperature<37.5°C );
- Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements;
Key exclusion criteria (17 listed)
- Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials;
- Enrolling or plan to enroll in other clinical trials (drug or vaccine);
- History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, LSIL, and cervical cancer) or history of pelvic radiotherapyherpes;
- History of diseases related to HPV infection (e.g. genital warts, VIN, VaIN, and related cancers) or history of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc.;
- Known allergy to any vaccine components or history of severe allergic diseases requiring treatment, including shock, laryngeal edema, urticarial, Henoch-Schonlein purpura, Arthus reaction, etc.;
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 Group among 9-14 yearsSubjects were planned to receive two doses of the study vaccine administered intramuscularly according to a 0, 6 month vaccination schedule. | Biological | Experimental: 2-doses Group |
| 3-doses Group among 9-19 yearsSubjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule. | Biological | Experimental: 3-doses Group |
| 3-doses Group among 20-26 yearsSubjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule. | Biological | Acitve Group |
Primary outcome
Primary immunogenicity outcome
Time frame: At month 8
Number of subjects receiving the whole schedule vaccination with antibody responses as assessed by GMT and SCR, change from baseline among the seronegative vaccine recipients at Month 8
6 secondary outcomes
Secondary immunogenicity outcome
Time frame: At month 12, 24, 36, 48 and 60
Number of subjecs with AEs
Time frame: Within 30 minutes (Days 0) after vaccination
Numbers of subjects with solication of AEs
Time frame: Within 8 days (Days 0-8) after vaccination
Numbers of subjects with unsolicited AEs
Time frame: Within days 0-30 after vaccination
Number of subjects receiving the whole schedule vaccination with SAEs
Time frame: Subjects receiving a 2-doses shceduled vaccination from Day o to Month 60; Subjects receiving a 3-doses shceduled vaccination from Day o to Month 12
Number of subjects with pregnancy events
Time frame: Subjects receiving a 2-doses shceduled vaccination from Day o to Month 60; Subjects receiving a 3-doses shceduled vaccination from Day o to Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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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.
Ting Huang study director
Sichuan Provincial Center 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?
A Phase 3 study testing 2-doses Group among 9-14 years, 3-doses Group among 9-19 years and 3-doses Group among 20-26 years in people with HPV Infections and Cervical Cancer Stage IIa, run by Shanghai Bovax Biotechnology Co., Ltd. at 1 site 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 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Huang (86-13330993324, cocoht@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary immunogenicity outcome (time frame: At month 8). 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 17 Apr 2024.