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

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05669625
• Other study ID #: CNBG-BIBP-VZV-07
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 26, 2022
• Est. completion date: September 14, 2026

Study information

• Verified date: June 2023
• Source: China National Biotec Group Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12440
• Est. completion date: September 14, 2026
• Est. primary completion date: April 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 59 Years

Eligibility

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;

• 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;

• Has any other factors that are not suitable for participation in the clinical trial in the judgment of the investigator

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• Investigational live attenuated varicella vaccine
0.5 ml/vial
• Placebo of live attenuated varicella vaccine
0.5 ml/vial

Locations

Country	Name	City	State
China	Qi County Center for Disease Control and Prevention	Hebi	Henan
China	Wuzhi County Center for Disease Control and Prevention	Jiaozuo	Henan
China	Wuyang County Center for Disease Control and Prevention	Luohe	Henan
China	Mianyang Anzhou District Center for Disease Control and Prevention	Mianyang	Sichuan
China	Southern County Center for Disease Control and Prevention	Nanchong	Sichuan
China	Neijiang City Center for Disease Control and Prevention	Neijiang	Sichuan
China	Lancang Lahu Autonomous County Center for Disease Control and Prevention	Pu'er	Yunnan
China	Sinan County Center for Disease Control and Prevention	Tongren	Guizhou
China	Songtao Miao Autonomous County Center for Disease Control and Prevention	Tongren	Guizhou
China	Yuping Dong Autonomous County Center for Disease Control and Prevention	Tongren	Guizhou
China	Yanshan County Center for Disease Control and Prevention	Wenshan	Yunnan
China	Huaiyin District Center for Disease Control and Prevention	Xuzhou	Jiangsu
China	Pei County Center for Disease Control and Prevention	Xuzhou	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Beijing Institute of Biological Products Co Ltd., Jiangsu Province Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The vaccine efficacy against laboratory-confirmed cases of moderate and severe varicella	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	The vaccine efficacy against clinical-confirmed cases	calculated based on the reported cases occurred 30 days after vaccination	number of cases reported 30 days after vaccination
Secondary	The incidences of adverse events (AEs)	AEs occurred within 30 days after injection will be collected	within 30 days after vaccination
Secondary	The incidences of serious adverse events (SAEs)	SAEs occurred within 6 months after vaccination will be collected	at least 6 months after vaccination
Secondary	The geometric mean titer (GMT) in the immunogenicity subgroup	Geometric mean titer (GMT) will be measured before and 30 days after vaccination	30 days after vaccination
Secondary	The seroconversion rate of the immunogenicity subgroup	The seroconversion rate will be calculated before and 30 days after vaccination	30 days after vaccination
Secondary	The geometric mean fold increase (GMI) of the immunogenicity subgroup	Geometric mean fold increase (GMI) of the immunogenicity group will be calculated based on the geometric mean titer	30 days after vaccination
Secondary	The immune persistence of the immunogenicity subgroup	Geometric mean titer (GMT) will be measured	1 year, 2 years, and 3 years after vaccination