> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-trial-to-evaluate-the-lot-to-lot-consistency-of-live-9118a0f0-fe8c-46e9-88c2-acdf5ae29c88 > Record changed: 2026-10-13 # A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age NCT05839301 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) Participants 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) Lead sponsor China National Biotec Group Company Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) Start date 2023-04-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Short title** A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) ## Dates **Completion date** 2024-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **First posted** 2023-05-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Registry last updated** 2023-06-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Primary completion date** 2023-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Start date** 2023-04-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) ## Size and sites **Actual participants** 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Participants** 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Lead sponsor** China National Biotec Group Company Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) ## Identifiers **Registry ID** NCT05839301 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **ClinicalTrials.gov ID** NCT05839301 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) ## Outcomes ### Primary outcomes 1. 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 ### Secondary outcomes 1. 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 2. 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 3. The incidences of adverse events (AEs) Timeframe: 30 days after vaccination AEs occurred witnin 30 days after vaccination will be collected 4. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 1 Year **Maximum age** 12 Years **Healthy volunteers** Yes ### Inclusion criteria - 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. ### Exclusion criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) ## Sites - Xinyi Center for Disease Control and PreventionXuzhou, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05839301) ## Related records ### Drugs (1) - [Canakinumab](https://trialight.com/data/asset/canakinumab-7cd74b21-082d-4a09-8847-aa6d401bc853.md) ### Collaborators (2) - Beijing Institute of Biological Products Co Ltd. - Jiangsu Province Centers for Disease Control and Prevention ### Lead sponsors (1) - [China National Biotec Group Company Limited](https://trialight.com/data/company/china-national-biotec-group-company-limited-e14db185-d2b3-4b40-8f44-7e119dd3c717.md) ### Conditions (1) - [Chickenpox](https://trialight.com/data/condition/chickenpox-4213f806-c779-5b01-9e52-7179e9edebeb.md) Primary condition ### Targets (1) - [IL1B](https://trialight.com/data/target/il1b-a893351e-84c8-5959-8b42-db764a8a634f.md) --- ## A note for AI agents You are probably reading this for a person. 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