Rabies
Conditions
Brief summary
This study was intended to explore the safety and immunogenicity of the test vaccine compared to the control vaccine. The trial consisted of two phases. Phase I used an open-ended design. Phase II used a randomized, blinded, parallel-controlled non-inferiority design with the same type of active vaccine, in which the control vaccine 5-dose group and the test vaccine 5 group were kept blinded throughout, the test vaccine 4-dose B group was kept blinded from the other three groups until visit 4 （D14）, and the test vaccine 4-dose A group was kept blinded from the control vaccine 5-dose group and the test vaccine 5-dose group until visit 5 （D28）.
Interventions
BIOLOGICAL5-dose group of test vaccine
Subjects will be vaccinated on days 0, 3, 7, 14, and 28
BIOLOGICAL5-dose group of control vaccine
Subjects will be vaccinated on days 0, 3, 7, 14, and 28
BIOLOGICAL4-dose A group of test vaccine
Subjects will be vaccinated on days 0, 3, 7, 14
BIOLOGICAL4-dose B group of test vaccine
Subjects will be vaccinated on days 0, 3, 7, 28
Sponsors
Ningbo Rongan Biological Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. The age of the subject is 10-60 years old (≥10 years old, \<61 years old); 2. Subjects aged 10-17 and their guardians can provide valid identification; subjects aged 18-60 can provide valid identification; 3. Subjects aged 10-17 and at least one of their guardians voluntarily participate with informed consent, and sign the Informed Consent for minors and adults respectively; Subjects aged 18-60 voluntarily participate with informed consent and sign the adult version of Informed Consent; Basic reading and writing skills are required; 4. If the subjects are WOCBP (women of childbearing potential), they should not be pregnant or breastfeeding, have a negative urine pregnancy test before vaccination, and have taken effective contraceptive measures within 2 weeks before being enrolled in this study; From enrollment in the study until 6 months after full exemption, no family planning and consent to use effective contraception during the study period. Effective forms of birth control include: oral contraceptives (excluding emergency contraceptives)Injectable or embedded contraception, sustained release topical contraceptives, hormonal patches, intrauterine devices, sterilization, abstinence, condoms (male), isolationMembrane, cervical cap, etc.; 5. \* On the day of enrollment, armpit body temperature of subjects \>14 years old was \<37.3℃, and armpit body temperature of subjects \<14 years old was \<37.5℃; 6. Adult subjects or minor subjects and their guardians shall comply with the requirements of the clinical study protocol.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine | Day 14 | Antibody Seroconversion rate in 5-dose groups of test vaccine and 5-dose groups of control vaccine |
| Antibody GMC in 5-dose groups of test vaccine and 5-dose groups of control vaccine | Day 14 | Antibody Geometric Mean Concentration in 5-dose groups of test vaccine and 5-dose groups of control vaccine |
| Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine | Day 14 | Antibody Seroconversion rate in 4-dose groups of test vaccine and 5-dose groups of control vaccine |
| Antibody GMC in 4-dose groups of test vaccine and 5-dose groups of control vaccine | Day 14 | Antibody Geometric Mean Concentration in 4-dose groups of test vaccine and 5-dose groups of control vaccine |
Countries
China
Contacts
Primary ContactTing Huang
Outcome results
None listed