Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Yunnan Center for Disease Control and Prevention | OTHER |
| Mile City Center for Disease Control and Prevention | UNKNOWN |
| Qiubei County Center for Disease Control and Prevention | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 30 days after full immunization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
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.
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yongjiang Liu, Bachelor | Beijing Health Guard Biotechnology, Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yunnan Center for Disease Prevention and Control | Kunming | Yunnan | 650022 | China |
No informed consent was obtained to disclose the subject's data and sample test results
Not provided
Not provided
Not provided
Not provided
Not provided
| Yanshan County Center for Disease Control and Prevention | UNKNOWN |
| National Institutes for Food and Drug Control, China | OTHER |
| Shanghai Stem Pharmaceutical Development Co., Ltd. | UNKNOWN |
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.
Not provided
Not provided
The Sponsor, investigators and biostatisticians will remain blinded to subject allocation.
|
| GARDASIL® 9 | Biological | 20-26 years possitive control group will be vaccinated at months 0, 2 and 6 |
|
| 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 | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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. | 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 | Through study completion, an average of 6 years |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D002583 | Uterine Cervical Neoplasms |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| D001005 | Anus Neoplasms |
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided