A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells) Administered to People Aged 10-60 Years With Different Immunization Procedures
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Rabies
- Sponsor
- Ningbo Rongan Biological Pharmaceutical Co., Ltd.
- Enrollment
- 2460
- Locations
- 4
- Primary Endpoint
- Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
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）.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The age of the subject is 10-60 years old (≥10 years old, \<61 years old);
- •Subjects aged 10-17 and their guardians can provide valid identification; subjects aged 18-60 can provide valid identification;
- •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;
- •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.;
- •\* 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℃;
- •Adult subjects or minor subjects and their guardians shall comply with the requirements of the clinical study protocol.
Exclusion Criteria
- •Exclusion Criteria at 1-dose:
- •A history of rabies vaccine immunization or rabies virus passive immunization was asked;
- •A history of grade 2 or 3 injury in animals susceptible to rabies virus (cats, dogs, etc.) within 12 months prior to the first dose of vaccination (the assessment criteria was the Technical Guidelines for Rabies Prevention and Control (2016));
- •Plan to participate in other clinical trials during the clinical study;
- •Allergic to any component of the test vaccine; History of severe allergies that require medical intervention, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, allergic necrosis reaction (Arthus reaction), severe urticaria, dyspnea, angioneurotic edema, etc.;
- •Have been diagnosed with a congenital or acquired immunodeficiency disease, such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other immune disease that the investigator has determined may affect the evaluation of the trial;
- •Known or suspected serious medical conditions upon inquiry include: severe respiratory diseases, poorly controlled chronic diseases, severe liver and kidney diseases, severe cardiovascular diseases, malignant tumors, etc.;
- •\* Medically unmanageable hypertension, such as systolic blood pressure \>120mmHg and/or diastolic blood pressure \>80mmHg in subjects 10 to 17 years of age prior to enrollment, systolic blood pressure of 140mmHg and/or diastolic blood pressure of 90mmHg in subjects 18 years of age and older;
- •Coagulation dysfunction (e.g. coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders diagnosed by a physician;
- •Asplenia, functional asplenia, and any condition resulting in asplenia or splenectomy;
Outcomes
Primary Outcomes
Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Time Frame: Day 42
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
Time Frame: Day 14
Antibody Geometric Mean Concentration in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Time Frame: Day 42
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
Time Frame: Day 14
Antibody Geometric Mean Concentration in 5-dose groups of test vaccine and 5-dose groups of control vaccine