Human Papillomavirus InfectionPhase 3NCT05662020
A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China
A Phase 3 study testing Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) and GARDASIL® 9 in people with Human Papillomavirus Infection, run by Beijing Health Guard Biotechnology, Inc at 1 site in China.
Trial summary
The study is to evaluate immune response induced by 9-valent HPV study vaccine is non-inferior to those induced by GARDASIL® 9 administrated with 3-dose schedule in female participants aged 20-26 years in China, if the immune response induced with same conditions in 9-19 age group is non-inferior to 20-26 age group… 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
- Human Papillomavirus Infection
- What is being tested?
- Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) and GARDASIL® 9
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,750 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2022to 23 Mar 2028
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female participants aged 9-26 years at the time of 1st dose vaccination (9 years ≤ age < 27 years).
- Participants aged 9-17 years can provide proof of ID for themselves and their legal guardians, and the trustee (if appropriate) can provide proof of delegation and ID; participants aged 18-26 years can provide proof of their legal ID.
- If the female participant is of childbearing age: she must not be pregnant, must not be breastfeeding, and have negative urine pregnancy test before vaccination (on the day of vaccination); voluntarily agree to use effective contraception within 2 weeks prior to enrollment in the study; have no plans to have children and agrees to use effective contraception from the time of enrollment until 1 month after full vaccination.
- Participants whom have not reached menarche: If menarche occurs between enrollment and 1 month after full vaccination, subjects must agree to use effective contraception until 1 month after full vaccination. [Effective contraceptive measures include: oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, extended-release topical contraceptives, hormonal patches, intrauterine device (IUD), sterilization, abstinence, condoms (male), diaphragm, cervical cap, etc.].
- The legal guardians or trustees of subjects of 9-17 years voluntarily signed the Informed Consent Form (ICF) with informed consent; Subjects of 9-17 years voluntarily signed the ICF for minors with informed consent; Subjects of 18-26 years voluntarily signed the ICF with informed consent.
- Participants and/or guardians are able to comply with the requirements of the clinical study protocol.
Who cannot join
- * Fever (axillary temperature ≥ 37.3°C in participants >14 years and ≥ 37.5°C in participants ≤14 years) within 24 hours prior to the 1st dose of vaccination.
- Previously vaccinated or have plans to administer other HPV vaccines during the study period.
- Plans to participate in other clinical studies during the study period or participate in other unfinished clinical trials within three months before participating in this clinical study; have used or plan to use other investigational or unregistered products (drugs or vaccines) within 28 days prior to 1st vaccination of this study vaccine.
- History of HPV positive, history of cervical lesions (e.g., abnormal cervical cancer screening results, history of abnormal cervical biopsy results, including cervical intraepithelial neoplasia (CIN), cervical low grade squamous intraepithelial lesions (LSIL), adenocarcinoma in situ or cervical cancer), history of HPV infection or abnormal cytology test or history of pelvic radiation therapy.
- History of anogenital disease associated with HPV infection (e.g., genital warts, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), anal intraepithelial neoplasia and associated carcinoma, etc.); or history of STDs (including syphilis, gonorrhea, genital chlamydia, genital herpes, soft chancre, lymphogranuloma venereum, inguinal sarcoidosis, etc.).
- Abnormalities of grade 1 or higher in the laboratory tests specified in this protocol, confirmed by clinician to be clinically significant (only applicable to the 20 subjects enrolled first in group B during the 1st stage).
Show all 29Show fewer
- Allergy to any component of the study vaccine (including aluminum hydroxide adjuvant, sodium chloride, histidine, polysorbate, etc.) or previous serious adverse events to vaccination; previous history of serious allergy, including anaphylaxis, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotizing reaction (Arthus reaction), severe urticaria, respiratory distress, angio neuroedema, etc.
- Participants with an impaired immune system or who have been diagnosed with an innate or acquired immune deficiency such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune disease.
- Epilepsy, excluding febrile convulsions under 2 years of age, or alcoholic epilepsy 3 years prior to abstinence from alcohol, or simple epilepsy not requiring treatment in the past 3 years.
- Current severe liver or kidney disease, serious cardiovascular disease, diabetes, malignancy, serious infectious disease (e.g., tuberculosis, HIV infection, etc.)
- Untreated/uncontrolled hypertension (systolic blood pressure > 120 mmHg and/or diastolic blood pressure > 80 mmHg) prior to vaccination for age 9-17 years; untreated/uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg) prior to vaccination for age 18 years and older.
- Physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiency, coagulopathies, platelet abnormalities) or clotting disorders
- Absence of spleen, asplenia, and any condition resulting asplenia or splenectomy.
- Participant has received immunosuppressive therapy within 1 month prior to vaccination or is scheduled to receive such therapy during the visit from the 1st dose to 30 days after full vaccination; e.g., long-term systemic glucocorticoid therapy (≥2 mg/kg/day for 2 weeks or more, e.g., prednisone or equivalent); topical medications (e.g., ointments, eye drops, inhalers, or nasal sprays) are allowed.
- Have received immunoglobulin products or blood-related products within 3 months prior to the 1st dose, or plan to use such products during visits between the 1st dose and 30 days after full vaccination.
- * Acute illness or in acute exacerbation of chronic disease or use of antipyretic, analgesic and antiallergic medications (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days prior to vaccination.
- * Administration of inactivated/recombinant/nucleic acid vaccines, etc. (non-attenuated vaccines) within 14 days prior to study entry or attenuated vaccines within 28 days prior to study enrollment.
- * Participant has donated blood within 1 week prior to enrollment or plans to donate blood during the period of 1st dose vaccination to 30 days after full vaccination.
- A history of psychiatric disorders or current psychiatric disorders result in the inability to comply with study requirements
- Based on the judgement of investigator, due to various medical, psychological, social, occupational factors or other conditions that are contrary to the study protocol or could affect the signing of ICF by the subject and/or guardian (trustee).
- Criteria for delay of the subsequent doses of vaccination:
- Participants with confirmed pregnancy prior to vaccination (on the day of vaccination), should delay vaccination to 6 weeks after termination of pregnancy in addition to having a negative urine pregnancy test.
- Vaccination may be delayed after evaluation by the investigator:
- On the day of vaccination, axillary temperature ≥ 37.3°C measured in participants aged > 14 years; axillary temperature ≥ 37.5°C measured in participants aged ≤ 14 years.
- Treated with immunomodulators, immunoglobulins, or blood-related products in an interval of less than 3 months with vaccination day.
- Acute illness or acute exacerbation of a chronic disease or use of antipyretic, analgesic and anti-allergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days prior to vaccination.
- Inadequate interval with other vaccinations (receipt of inactivated/recombinant/nucleic acid vaccine, etc. (non-attenuated vaccine) within 14 days or within 28 days for attenuated vaccine before vaccination).
- The presence of other conditions that the investigator considers to warrant a delay in vaccination.
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Trial locations and contacts
1 site in 1 country.
China1 site
Yunnan Center for Disease Prevention and Control
Kunming, Yunnan, 650022
About this study
Official title: A Parallel-controlled Study to Evaluate the Immunogenicity and Safety of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in Healthy Female Participants Aged 9-26 Years in China
The study is to evaluate immune response induced by 9-valent HPV study vaccine is non-inferior to those induced by GARDASIL® 9 administrated with 3-dose schedule in female participants aged 20-26 years in China, if the immune response induced with same conditions in 9-19 age group is non-inferior to 20-26 age group, and if the immune response induced by 9-valent HPV study vaccine administrated with 2-dose schedule in females aged 9-14 years is non-inferior to 3-dose schedule in females aged 20-26 years.
Read the detailed description
This is a parallel-controlled study. A total of 2,750 participants will be enrolled in this study: 9-14 years (2 doses) group and 9-19 years (3 doses) group are of non-randomized, open label design; 20-26 years (3 doses) group will be randomized and blinded.
9-14 age group and group 9-19 age group will be enrolled in two stages: 20 subjects in 9-19 age group will be enrolled first. After assessing the safety data (including laboratory test data) within 7 days of 1st dose vaccination in these 20 subjects, and if the suspension criteria are not met, the remaining 620 subjects in 9-19 age group and 640 subjects in 9-14 age group will be enrolled subsequently. 20-26 age group will be enrolled directly, with no stage entry requirements. Eligible subjects will be enrolled to received vaccines accordingly. Subjects who have reached menarche will undergo urine pregnancy test prior to each dose of vaccination (on the vaccine day.)
- Conditions
- Human Papillomavirus Infection
- Being tested
- Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli), GARDASIL® 9
- Keywords
- CIN, VIN, VaIN, AIN, Cervical cancer, Vaginal cancer, Vulvar cancer, Anal cancer, genital warts, Genital warts
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms, Anus Neoplasms, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)Biological
9-19 years group (3 doses) and 20-26 years group (3 doses) will be vaccinated at months 0, 2, 6. 9-14 years group (2 doses) will be vaccinated at months 0, 6.
GARDASIL® 9Biological
20-26 years possitive control group will be vaccinated at months 0, 2 and 6
| Study group | Role | What they receive |
|---|---|---|
| The Group of Investigational Vaccine | Experimental | 0.5 mL suspension for injection, each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein. Receives: Biological: Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) |
| The Group of Active Control Vaccine | Active comparator | 0.5-mL suspension for injection, each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein. Receives: Biological: GARDASIL® 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group.
Measured: 30 days after full immunization
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group
Measured: 30 days after full immunization
Secondary outcomes (12)
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group and possitive control group
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: 9-14 years (2 doses) group, 9-19 years (3 doses) group, and participants in control vaccine group: 20-26 years (3 doses) group
Measured: 30 days after full immunization
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group and possitive control group
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: 9-14 years (2 doses) group, 9-19 years (3 doses) group, and participants in control vaccine group: 20-26 years (3 doses) group
Measured: 30 days after full immunization
GMT of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies for all subjects
GMT of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination for all participants.
Measured: 30 days after full immunization
SCR of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies for all subjects
SCR of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination for all participants.
Measured: 30 days after full immunization
GMT of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies after first vaccination
GMT of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) at 12 months, 24 months, 36 months, 48 months, 60 months and 72 months after first vaccination for all participants.
Measured: From the 12th month to 72nd month after first dose immunization
SCR of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies after first vaccination
SCR of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) at 12 months, 24 months, 36 months, 48 months, 60 months and 72 months after first vaccination for all participants.
Measured: From the 12th month to 72nd month after first dose immunization
Abnormality rate of laboratory test
First 20 subjects enrolled in 9-19 years group: abnormality rate of laboratory test on Day 3 after each dose of vaccination.
Measured: Day 3 after each dose
Follow up 30 minutes observation after injection to collect the Incidence, intensity, and duration of AEs
Follow up 30 minutes observation after injection to collect the Incidence, intensity, and duration of AEs within 30 minutes after each dose of vaccination for all participants
Measured: 30 minutes after each dose
Collect the questionnaires to gather the information related to the Incidence, intensity, and duration of solicited (local and systemic) AEs which within 7 days after each dose
Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of solicited (local and systemic) AEs which within 7 days after each dose of vaccination for all participants
Measured: 0-7 days after each dose
Collect the questionnaires to gather the information related to Incidence, intensity, and duration of unsolicited AEs which within 30 days after each dose
Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to Incidence, intensity, and duration of unsolicited AEs which within 30 days after each dose of vaccination for all participants
Measured: 0-30 days after each dose
Collect the questionnaires to gather the information related to the Incidence, intensity, and duration of SAE
Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of SAE which within 72 months after first vaccination for all participants.
Measured: Through study completion, an average of 6 years
Collect the questionnaires to gather the information related to the Incidence, intensity, and duration of the occurrence of pregnancy events
Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of the occurrence of pregnancy events which within 72 months after first vaccination for all participants
Measured: Through study completion, an average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start23 Mar 2022
- Primary completion7 Nov 2022
- Study completion23 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus 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
- Model description
- A total of 2,750 participants were enrolled in this study: 9-14 years (2 doses) group was administrated with investigational vaccine on 0 Day, 6th month, and 9-19 years (3 doses) group was administrated with investigational vaccine on 0 Day, 2nd month and 6th month. Both of these two group are of non-randomized, open label design; 20-26 years (3 doses) group was randomized at a 1: 1 ratio to receive the investigational vaccine or the positive control, respectivelyon 0 Day, 2nd month and 6th month.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Health Guard Biotechnology, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yunnan Center for Disease Control and Prevention, Mile City Center for Disease Control and Prevention, Qiubei County Center for Disease Control and Prevention, Yanshan County Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Shanghai Stem Pharmaceutical Development Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yongjiang Liu, Bachelor, Study chair, Beijing Health Guard Biotechnology, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662020
- Sponsor's protocol ID
- KLWS-V502-04
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No informed consent was obtained to disclose the subject's data and sample test results
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-controlled Study to Evaluate the Immunogenicity and Safety of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in Healthy Female Participants Aged 9-26 Years in China
- ClinicalTrials.gov ID
- NCT05662020
- Acronym / sponsor ID
- KLWS-V502-04
- Conditions
- Human Papillomavirus Infection
- Keywords
- CIN, VIN, VaIN, AIN, Cervical cancer, Vaginal cancer, Vulvar cancer, Anal cancer, genital warts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,750 participants (actual)
- Lead sponsor
- Beijing Health Guard Biotechnology, IncIndustry (pharma, biotech, devices)
- Collaborators
- Yunnan Center for Disease Control and Prevention, Mile City Center for Disease Control and Prevention, Qiubei County Center for Disease Control and Prevention, Yanshan County Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Shanghai Stem Pharmaceutical Development Co., Ltd.
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 23 Mar 2028 (estimated)
- First posted
- 22 Dec 2022 (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.
The study is to evaluate immune response induced by 9-valent HPV study vaccine is non-inferior to those induced by GARDASIL® 9 administrated with 3-dose schedule in female participants aged 20-26 years in China, if the immune response induced with same conditions in 9-19 age group is non-inferior to 20-26 age group, and if the immune response induced by 9-valent HPV study vaccine administrated with 2-dose schedule in females aged 9-14 years is non-inferior to 3-dose schedule in females aged 20-26 years.
Detailed description
This is a parallel-controlled study. A total of 2,750 participants will be enrolled in this study: 9-14 years (2 doses) group and 9-19 years (3 doses) group are of non-randomized, open label design; 20-26 years (3 doses) group will be randomized and blinded.
9-14 age group and group 9-19 age group will be enrolled in two stages: 20 subjects in 9-19 age group will be enrolled first. After assessing the safety data (including laboratory test data) within 7 days of 1st dose vaccination in these 20 subjects, and if the suspension criteria are not met, the remaining 620 subjects in 9-19 age group and 640 subjects in 9-14 age group will be enrolled subsequently. 20-26 age group will be enrolled directly, with no stage entry requirements. Eligible subjects will be enrolled to received vaccines accordingly. Subjects who have reached menarche will undergo urine pregnancy test prior to each dose of vaccination (on the vaccine day.)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total of 2,750 participants were enrolled in this study: 9-14 years (2 doses) group was administrated with investigational vaccine on 0 Day, 6th month, and 9-19 years (3 doses) group was administrated with investigational vaccine on 0 Day, 2nd month and 6th month. Both of these two group are of non-randomized, open label design; 20-26 years (3 doses) group was randomized at a 1: 1 ratio to receive the investigational vaccine or the positive control, respectivelyon 0 Day, 2nd month and 6th month.
| Arm | Type | Receives |
|---|---|---|
| The Group of Investigational Vaccine | Experimental | Biological: Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)0.5 mL suspension for injection, each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein. |
| The Group of Active Control Vaccine | Active comparator | Biological: GARDASIL® 90.5-mL suspension for injection, each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein. |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Female participants aged 9-26 years at the time of 1st dose vaccination (9 years ≤ age < 27 years).
- Participants aged 9-17 years can provide proof of ID for themselves and their legal guardians, and the trustee (if appropriate) can provide proof of delegation and ID; participants aged 18-26 years can provide proof of their legal ID.
- If the female participant is of childbearing age: she must not be pregnant, must not be breastfeeding, and have negative urine pregnancy test before vaccination (on the day of vaccination); voluntarily agree to use effective contraception within 2 weeks prior to enrollment in the study; have no plans to have children and agrees to use effective contraception from the time of enrollment until 1 month after full vaccination.
- Participants whom have not reached menarche: If menarche occurs between enrollment and 1 month after full vaccination, subjects must agree to use effective contraception until 1 month after full vaccination. [Effective contraceptive measures include: oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, extended-release topical contraceptives, hormonal patches, intrauterine device (IUD), sterilization, abstinence, condoms (male), diaphragm, cervical cap, etc.].
- The legal guardians or trustees of subjects of 9-17 years voluntarily signed the Informed Consent Form (ICF) with informed consent; Subjects of 9-17 years voluntarily signed the ICF for minors with informed consent; Subjects of 18-26 years voluntarily signed the ICF with informed consent.
Key exclusion criteria (29 listed)
- * Fever (axillary temperature ≥ 37.3°C in participants >14 years and ≥ 37.5°C in participants ≤14 years) within 24 hours prior to the 1st dose of vaccination.
- Previously vaccinated or have plans to administer other HPV vaccines during the study period.
- Plans to participate in other clinical studies during the study period or participate in other unfinished clinical trials within three months before participating in this clinical study; have used or plan to use other investigational or unregistered products (drugs or vaccines) within 28 days prior to 1st vaccination of this study vaccine.
- History of HPV positive, history of cervical lesions (e.g., abnormal cervical cancer screening results, history of abnormal cervical biopsy results, including cervical intraepithelial neoplasia (CIN), cervical low grade squamous intraepithelial lesions (LSIL), adenocarcinoma in situ or cervical cancer), history of HPV infection or abnormal cytology test or history of pelvic radiation therapy.
- History of anogenital disease associated with HPV infection (e.g., genital warts, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), anal intraepithelial neoplasia and associated carcinoma, etc.); or history of STDs (including syphilis, gonorrhea, genital chlamydia, genital herpes, soft chancre, lymphogranuloma venereum, inguinal sarcoidosis, 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 |
|---|---|---|
| Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)9-19 years group (3 doses) and 20-26 years group (3 doses) will be vaccinated at months 0, 2, 6. 9-14 years group (2 doses) will be vaccinated at months 0, 6. | Biological | The Group of Investigational Vaccine |
| GARDASIL® 920-26 years possitive control group will be vaccinated at months 0, 2 and 6 | Biological | The Group of Active Control Vaccine |
Primary outcome
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group
Time frame: 30 days after full immunization
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group.
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group
Time frame: 30 days after full immunization
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group
12 secondary outcomes
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group and possitive control group
Time frame: 30 days after full immunization
Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group and possitive control group
Time frame: 30 days after full immunization
GMT of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies for all subjects
Time frame: 30 days after full immunization
SCR of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies for all subjects
Time frame: 30 days after full immunization
GMT of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies after first vaccination
Time frame: From the 12th month to 72nd month after first dose immunization
SCR of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies after first vaccination
Time frame: From the 12th month to 72nd month after first dose immunization
Abnormality rate of laboratory test
Time frame: Day 3 after each dose
Follow up 30 minutes observation after injection to collect the Incidence, intensity, and duration of AEs
Time frame: 30 minutes after each dose
Collect the questionnaires to gather the information related to the Incidence, intensity, and duration of solicited (local and systemic) AEs which within 7 days after each dose
Time frame: 0-7 days after each dose
Collect the questionnaires to gather the information related to Incidence, intensity, and duration of unsolicited AEs which within 30 days after each dose
Time frame: 0-30 days after each dose
Collect the questionnaires to gather the information related to the Incidence, intensity, and duration of SAE
Time frame: Through study completion, an average of 6 years
Collect the questionnaires to gather the information related to the Incidence, intensity, and duration of the occurrence of pregnancy events
Time frame: Through study completion, an average of 6 years
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 27 Dec 2022.
- Individual participant dataSharing planned: No. No informed consent was obtained to disclose the subject's data and sample test results
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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.
Yongjiang Liu, Bachelor study chair
Beijing Health Guard Biotechnology, Inc
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 Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) and GARDASIL® 9 in people with Human Papillomavirus Infection, run by Beijing Health Guard Biotechnology, Inc 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 6 inclusion and 29 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 27 Dec 2022. 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?
Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies for study vaccine group (time frame: 30 days after full immunization). The study lists 2 primary outcomes in all. 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 27 Dec 2022.