Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
A Randomized, Blind, Controlled Clinical Trial to Evaluate Safety and Immunogenicity of Live Attenuated Varicella Vaccine After a Two-dose Vaccination Course in Healthy Population Aged ≥13 Years Old
1 other identifier
interventional
2,400
1 country
1
Brief Summary
This a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity of a two doses vaccination of investigational vaccine with 0,28 day, 0,42 day and 0,56 day immunization schedule in population aged ≥13 years old.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2021
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2021
CompletedFirst Posted
Study publicly available on registry
August 20, 2021
CompletedStudy Start
First participant enrolled
September 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2026
ExpectedMarch 8, 2024
March 1, 2024
4 months
July 26, 2021
March 6, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Seroconversion rate of the antibody
The seroconversion rate of the antibody 28 days among all subjects after the second vaccination.
Day 28 after the whole schedule
GMT of the antibody
The GMT of the antibody 28 days among all subjects after the second vaccination.
Day 28 after the whole schedule
Secondary Outcomes (6)
GMI of the antibody
Day 28 after the whole schedule
Seroconversion rate, positive rate, GMT and GMI of the antibody
Day 28,Day 42 and day 56 after the first vaccination
Incidence of adverse reactions within 0~28 days after each dose
Within 0~28 days after each dose
Incidence of adverse reactions within 0~14 days after each dose vaccination
Within 0~14 days after each dose
Incidence of grade 3 and above adverse reactions
within 0~28 days after each dose
- +1 more secondary outcomes
Study Arms (4)
Experimental Group with the immunization course of 0,28 days, 0,42 days or 0,56 days
EXPERIMENTAL960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
Control Group
ACTIVE COMPARATOR960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
Experimental Group with the immunization course of 0, 70 days
EXPERIMENTAL320 subjects (including 160 children aged 13-17 years and 160 adults aged 18 years and older) will receive two doses of the experimental vaccine with the immunization course of 0, 70 days.
Placebo group
PLACEBO COMPARATOR160 subjects (including 80children aged 13-17 years and 80 adults aged 18 years and older) will receive two doses of the placebo with the immunization course of 0, 70 days.
Interventions
live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
live varicella-zoster virus in trehalose,human serum albumin,sodium glutamate,sucrose,glucose,carbamide,arginine and injection water per injection
Eligibility Criteria
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:
- History of chickenpox or shingles;
- 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 asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
- 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)and diabetes that cannot be controlled by drugs, liver or kidney diseases;
- Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) 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 3 months;
- Participating in other drug/vaccine clinical trial;
- Receipt of attenuated live vaccines in the past 28 days;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yucheng Center for Disease Control and Prevention
Shangqiu, Henan, 476300, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lili Huang, Bachelor
Henan Provincial Center for Disease Prevention and Control
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
July 26, 2021
First Posted
August 20, 2021
Study Start
September 30, 2021
Primary Completion
February 9, 2022
Study Completion (Estimated)
September 20, 2026
Last Updated
March 8, 2024
Record last verified: 2024-03