HPV (Human Papillomavirus)-Associated Carcinoma, Human Papillomavirus (HPV) Infection
Conditions
Keywords
hpv, hpv vaccine
Brief 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 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
Interventions
BIOLOGICAL2 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.
BIOLOGICAL3 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.
Sponsors
National Vaccine and Serum Institute, China
Chengdu Institute of Biological Products Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
First dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among subjects who were seronegative at baseline (pre-vaccination) | 1 month after completion of the vaccination series |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) | 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). | 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) | 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) | 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 | 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 | 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 | 1 month after completion of the vaccination series | — |
| Seropositivity rate of neutralizing antibodies against HPV types 6, 11, 16, and 18 in all subjects | 6, 12, 24, 36, 48, 60, and 72 months after completion of the vaccination series | — |
| The number of cases of AE（Adverse Event） | From the first vaccination through 1 month after completion of the vaccination series | — |
| The incidence of AEs leading to subjects withdrawing from clinical trials | From the first vaccination through 1 month after completion of the vaccination series | — |
| Distribution of severity of AE | From the first vaccination through 1 month after completion of the vaccination series | — |
| The incidence of AEs | 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 | From the first vaccination through 6 months after completion of the vaccination series | — |
| Collect information about previous pregnancies of pregnant women survey | From the first vaccination through the end of the study（Approximately 72 months） | Such as previous pregnancy, current pregnancy mode, etc |
| Obtain pregnancy outcomes in pregnant subjects survey | From the first vaccination through the end of the study（Approximately 72 months） | Collecting newborn information |
Countries
China
Outcome results
None listed