A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age
NCT05839301
Phase
Phase 3
Recruitment status
Unknown
Participants
1,200
Lead sponsor
China National Biotec Group Company Limited
Start date
2023-04-27
Number of sites
- Summary
- The goal of this clinical trial is to evaluate the lot-to-lot consistency, immunogenicity, and safety of live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.
- Short title
- A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age
- Official title
- A Single-center, Randomized, Double-blind Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2024-04-30
- First posted
- 2023-05-03
- Registry last updated
- 2023-06-18
- Primary completion date
- 2023-07-30
- Start date
- 2023-04-27
- Actual participants
- 1,200
- Participants
- 1,200
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- China National Biotec Group Company Limited
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05839301
- ClinicalTrials.gov ID
- NCT05839301
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Triple masking
- Masked roles
- Participants, Investigators, Outcome assessors
Sources for study design
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies
Timeframe: 30 days after vaccination
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization
Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies
Timeframe: 30 days after vaccination
Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies
Timeframe: 30 days after vaccination
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies 30 days after vaccination in the whole population
The incidences of adverse events (AEs)
Timeframe: 30 days after vaccination
AEs occurred witnin 30 days after vaccination will be collected
The incidences of serious adverse events (SAEs) and Adverse Event of Special Interest(AESI)
Timeframe: 6 months after vaccination
SAEs and AESI occurred witnin 6 months after vaccination will be collected
Sources for outcomes
- Sex
- All
- Age groups
- Children
- Minimum age
- 1 Year
- Maximum age
- 12 Years
- Healthy volunteers
- Yes
- Age 1 to 12 years on the day of enrollment ,male or female, and able to provide legal identity certificate.
- Subjects and/or guardians have the ability to understand the study requirements and process, agree to participate in the clinical trial and sign the informed consent form.
- Axillary temperature ≤ 37.0 ° C on the day of enrollment.
- Previous vaccination against varicella (eg, varicella vaccine, measles + varicella vaccine).
- History of varicella or herpes zoster infection, or exposure to varicella/herpes zoster within 30 days of enrollment or suspected varicella/herpes zoster;
- Current use of salicylates (including salicylic acid, aspirin, diflunisal, p-aminosalicylic acid (sodium), salsalsalate, benorilate, etc.), or planned long-term use during the study.
- Febrile illness (axillary temperature ≥ 38.5 ° C) or use of antipyretic, analgesic, and anti-allergic drugs (eg, acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination.
- History of allergy to vaccine ingredients and excipients or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria.
- History of epilepsy, convulsions, or convulsions, or a family history of psychosis.
- Impaired immune function or has been 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.
- Patients suffering from serious congenital malformations, genetic diseases, serious cardiovascular diseases, serious liver/kidney diseases, diabetes with complications, malignant tumors, severe malnutrition.
- Immunosuppressant therapy such as chronic oral or injectable glucocorticoid therapy (≥ 14 days at doses ≥ 2 mg/kg/day or ≥ 20 mg/day prednisone or equivalent prednisone dose) within 3 months prior to administration of trial vaccine or planned 30 days following administration, but not limited by topical use (eg, ointment, eye drops, inhalers, or nasal sprays).
- Receiving blood/blood-related products or immunoglobulins 3 months before vaccination or planning to use such products 30 days after vaccination.
- Vaccination with a live attenuated vaccine within 30 days or any vaccine within 14 days prior to vaccination.
- Absence of spleen or splenectomy due to any condition such as splenectomy.
- Patients with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous injection.
- Infectious, suppurative and allergic skin diseases.
- Participating in other investigational or non-registered product (drug, vaccine or device, etc.) clinical trials, or planning to participate in other clinical trials before the end of this clinical trial.
- Subject has any other factor that, in the judgment of the investigator, would make the subject unsuitable for participation in the clinical trial.
Sources for eligibility
- Xinyi Center for Disease Control and PreventionXuzhou, China
Sources for sites
Related records
Drugs (1)
Collaborators (2)
- Beijing Institute of Biological Products Co Ltd.
- Jiangsu Province Centers for Disease Control and Prevention
Lead sponsors (1)
Conditions (1)
- Chickenpox Primary condition