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

Last updated: December 24, 2023
Sponsor: Shanghai Institute Of Biological Products
Overall Status: Completed

Phase

3

Condition

Herpes Simplex Infections

Chickenpox (Varicella Zoster Infection)

Throat And Tonsil Infections

Treatment

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

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

Clinical Study ID

NCT05158777
2020LP00094-III
  • Ages > 13
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • 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 vaccinecomponents, or serious adverse reactions to the vaccine, such as urticaria, dyspnea,angioedema and abdominal pain;
  • Congenital malformations or developmental disorders, genetic defects, severemalnutrition, etc.;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension (adult fieldmeasurement: SBP ≥140mmHg or diastolic blood pressure ≥90mmHg) that could not becontrolled by drugs, diabetes, liver and kidney diseases, malignant tumors, etc.;
  • Family history of psychosis,severe neurological disease (epilepsy, convulsions ortwitching) or mental illness;
  • Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, aspleniaor 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 (excludingallergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitissuperficial 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;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Onset of various acute or chronic diseases within 7 days prior to the study;
  • According to the investigator's judgment, the subject has any other factors that arenot suitable for participating in the clinical trial.

Study Design

Total Participants: 2480
Treatment Group(s): 2
Primary Treatment: Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.
Phase: 3
Study Start date:
February 13, 2022
Estimated Completion Date:
November 14, 2022

Study Description

This study is a randomized, blind, controlled phase III clinical trial in population aged ≥13 years old. The experimental vaccine will be manufactured by Shanghai Institute of Biological Products Co.,Ltd.. A total of 2480 subjects aged 13 years and older will be enrolled with 1240 subjects in 13~17 years old group and1240 subjects in 18 years and older group. 1240 subjects in each age group would be randomly divided into experimental group and control group according to 1:1 ratio, and subjects will receive two doses of vaccine with the immunization course of 0,28 days or 0,56 days. In addition, 400 subjects from experimental group (100 subjects per subgroup) would be selected to collect blood at 3 and 5 years after immunization to evaluate immune persistence of live attenuated varicella vaccines.

Connect with a study center

  • Henan Provincial Center for Disease Prevention and Control

    Zhenzhou, Henan
    China

    Site Not Available

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