A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine

NCT05669625 | Active Not Recruiting Phase 3

• 1 other identifier: CNBG-BIBP-VZV-07
• Study Type: interventional
• Target: 12,440
• Locations: 1 country
• Sites: 13

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.

Conditions

Varicella

Keywords

vaccine efficacy; varicella vaccine; safety; immunogenicity

Outcome Measures

Primary Outcomes (2)

• The incidences of varicella in each group

  The first 24 cases of varicella occurred 30 days after injection will be collected

  number of cases reported 30 days after vaccination

• The efficacy of the live attenuated varicella vaccine

  The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination

  number of cases reported 30 days after vaccination

Secondary Outcomes (8)

• The vaccine efficacy against laboratory-confirmed cases of moderate and severe varicella

  number of cases reported 30 days after vaccination

• The vaccine efficacy against clinical-confirmed cases

  number of cases reported 30 days after vaccination

• The incidences of adverse events (AEs)

  within 30 days after vaccination

• The incidences of serious adverse events (SAEs)

  at least 6 months after vaccination

• The geometric mean titer (GMT) in the immunogenicity subgroup

  30 days after vaccination

Study Arms (2)

Experimental Group

EXPERIMENTAL

Single subcutaneous injection of the investigational vaccine (0.5 ml)

Biological: Investigational live attenuated varicella vaccine

Placebo Group

PLACEBO COMPARATOR

Single subcutaneous injection of the investigational placebo (0.5 ml)

Biological: Placebo of live attenuated varicella vaccine

Interventions

Investigational live attenuated varicella vaccine BIOLOGICAL

0.5 ml/vial

Experimental Group

Placebo of live attenuated varicella vaccine BIOLOGICAL

0.5 ml/vial

Placebo Group

Eligibility Criteria

• Age: 1 Year - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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；
• Have received a live attenuated vaccine within 30 days prior to the trial vaccine, or any vaccine within 14 days prior to vaccination;
• Asplenectomy or splenectomy due to any condition (e.g. splenectomy);
• Those with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous injection;
• Suffering from various infectious, purulent or allergic skin diseases;
• Are participating in other investigational or unregistered clinical trials of products (drugs, vaccines or devices, etc.), or have plans to participate in other clinical trials before the end of this clinical trial;

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Beijing Institute of Biological Products Co Ltd.: collaborator
• Jiangsu Province Center for Disease Control and Prevention: collaborator

Study Sites (13)

Sinan County Center for Disease Control and Prevention

Tongren, Guizhou, China

Location

Songtao Miao Autonomous County Center for Disease Control and Prevention

Tongren, Guizhou, China

Location

Yuping Dong Autonomous County Center for Disease Control and Prevention

Tongren, Guizhou, China

Location

Qi County Center for Disease Control and Prevention

Hebi, Henan, China

Location

Wuzhi County Center for Disease Control and Prevention

Jiaozuo, Henan, China

Location

Wuyang County Center for Disease Control and Prevention

Luohe, Henan, China

Location

Pei County Center for Disease Control and Prevention

Xuzhou, Jiangsu, 221600, China

Location

Huaiyin District Center for Disease Control and Prevention

Xuzhou, Jiangsu, 223300, China

Location

Mianyang Anzhou District Center for Disease Control and Prevention

Mianyang, Sichuan, China

Location

Southern County Center for Disease Control and Prevention

Nanchong, Sichuan, China

Location

Neijiang City Center for Disease Control and Prevention

Neijiang, Sichuan, China

Location

Lancang Lahu Autonomous County Center for Disease Control and Prevention

Pu'er, Yunnan, China

Location

Yanshan County Center for Disease Control and Prevention

Wenshan, Yunnan, China

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Hongxing Pan

  Jiangsu Province Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 3, 2023
• Study Start: December 26, 2022
• Primary Completion: April 14, 2024
• Study Completion (Estimated): September 14, 2026
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)