Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old

NCT05158777 | Completed Phase 3

• 1 other identifier: 2020LP00094-III
• Study Type: interventional
• Target: 2,480
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of a two doses vaccination of investigational vaccine with 0,28 day and 0,56 day immunization schedule in population aged ≥13 years old.

Conditions

Varicella

Outcome Measures

Primary Outcomes (2)

• Seroconversion rate of HI antibody

  The seroconversion rate of the antibody 42 days among all subjects after the second vaccination.

  Day 42 after the whole schedule

• GMT of HI antibody

  The GMT of the antibody 42 days among all subjects after the second vaccination.

  Day 42 after the whole schedule

Secondary Outcomes (4)

• Seroprotection rate of HI antibody

  Day 42 after the whole schedule

• Incidence of adverse reactions within 30 minutes after each dose

  Within 30 minutes after each dose

• Incidence of adverse reactions within 0~28 days after each dose

  Within 0~28 days after each dose

• Incidence of serious adverse events

  From vaccination to 6 months after the second vaccination

Study Arms (2)

Experimental Group with the immunization course of 0,28 days or 0,56 days

EXPERIMENTAL

1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days or 0,56 days.

Biological: Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.

Control Group

ACTIVE COMPARATOR

1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days or 0,56 days.

Biological: Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd

Interventions

Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. BIOLOGICAL

live varicella-zoster virus in 0.5 mL of sucrose, sodium chloride, potassium chloride, sodium glutamate, phosphate and injection water per injection

Experimental Group with the immunization course of 0,28 days or 0,56 days

Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd BIOLOGICAL

live varicella-zoster virus in 0.5 mL of mannitol, dextrose tincture, sucrose, trehalose, human serum albumin and injection water per injection

Control Group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy population aged 13 years and above;
• Proven legal identity;
• The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 13-17 years, both subjects and guardians need to sign the informed consent form).

You may not qualify if:

• Disease history or vaccine history of chickenpox or shingles;
• Have fever before vaccination, axillary temperature \>37.0°C;
• Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 6 months;
• History of severe allergy and asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and abdominal pain;
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
• Autoimmune disease or immunodeficiency / immunosuppression;
• Severe chronic diseases, severe cardiovascular diseases, hypertension (adult field measurement: SBP ≥140mmHg or diastolic blood pressure ≥90mmHg) that could not be controlled by drugs, diabetes, liver and kidney diseases, malignant tumors, etc.;
• Family history of psychosis,severe neurological disease (epilepsy, convulsions or twitching) or mental illness;
• Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia or splenectomy resulting from any condition;
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
• History of alcohol or drug abuse;
• Receipt of blood products within in the past 6 months;
• Participating in other drug/vaccine clinical trial;
• Receipt of attenuated live vaccines in the past 28 days;

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Henan Provincial Center for Disease Prevention and Control

Zhenzhou, Henan, China

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

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

Study Officials

• Yanxia Wang

  Henan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: February 13, 2022
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)