A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Live Attenuated Varicella Vaccine in Healthy People
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Varicella
- Sponsor
- China National Biotec Group Company Limited
- Enrollment
- 12440
- Locations
- 13
- Primary Endpoint
- The incidences of varicella in each group
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this clinical trial is to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.
Detailed Description
This trial is aim to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children aged 1-12 years old. This study will be conducted in two stage. the stage 1 adopts an open design, and 20 subjects aged 18\~59 and 13\~17 years old (18\~59 years old→ 13\~17 years old, sequentially enrolled) are enrolled, and 1 dose of the trial vaccine is administered to explore safety. The stage 2 adopts a randomized, blinded, placebo-controlled design, 12400 healthy participants aged 1-12 years old will be randomly assigned into experimental group or control group with the ratio 1:1.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteer between 13 - 59 years old for Stage 1, 1-12 years old for Stage 2, and be able to provide legal identification ;
- •Subject and/or guardian has the ability to understand study requirements and processes, consent to participate in clinical trials, and sign informed consent forms;
- •Consent to use effective contraception during study participation, no pregnancy and no family planning (for women of childbearing potential or their spouses);
- •Axillary temperature ≤ 37.0 °C on the day of enrollment;
Exclusion Criteria
- •Has received any varicella vaccine before ( Not applicable to Stage 1）;
- •Has history of varicella or herpes zoster infection, or contact with varicella/shingles patients or suspected varicella/shingles patients within 30 days before enrollment ( Not applicable to Stage 1）;
- •Currently using salicylates (including salicylic acid, aspirin, diflunisalin, p-aminosalicylate (sodium), dicalicylate, benoxate, etc.), or plan to use it for a long time during the study；
- •Have had febrile illness (axillary temperature ≥ 38.5 °C) or used antipyretic, analgesic, anti-allergic drugs (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination；
- •Have a history of allergy to vaccine components and excipients or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, local allergic necrosis (Arthus) reaction, severe urticaria, etc；
- •Have a history of epilepsy, convulsions or convulsions, and have a family history of severe neurological disease or psychosis
- •Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases；
- •With severe congenital malformations, hereditary diseases, serious cardiovascular diseases, serious liver/kidney diseases, complicated diabetes, malignant tumors, and severe malnutrition
- •Immunosuppressant therapy, such as long-term oral or injectable glucocorticoid therapy (≥ 14 days, dose ≥2 mg/kg/day or ≥20 mg/day or equivalent to prednisone), within 3 months prior to enrollment or planned within 30 days of vaccination, but topical medications (e.g., ointments, eye drops, inhalers, or nasal sprays) are not restricted
- •Have received blood/blood-related products or immunoglobulins 3 months prior to vaccination, or plan to use such products 30 days after vaccination；
Outcomes
Primary Outcomes
The incidences of varicella in each group
Time Frame: number of cases reported 30 days after vaccination
The first 24 cases of varicella occurred 30 days after injection will be collected
The efficacy of the live attenuated varicella vaccine
Time Frame: number of cases reported 30 days after vaccination
The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination
Secondary Outcomes
- The seroconversion rate of the immunogenicity subgroup(30 days after vaccination)
- The incidences of serious adverse events (SAEs)(at least 6 months after vaccination)
- The vaccine efficacy against laboratory-confirmed cases of moderate and severe varicella(number of cases reported 30 days after vaccination)
- The incidences of adverse events (AEs)(within 30 days after vaccination)
- The geometric mean titer (GMT) in the immunogenicity subgroup(30 days after vaccination)
- The vaccine efficacy against clinical-confirmed cases(number of cases reported 30 days after vaccination)
- The geometric mean fold increase (GMI) of the immunogenicity subgroup(30 days after vaccination)
- The immune persistence of the immunogenicity subgroup(1 year, 2 years, and 3 years after vaccination)