Study on Booster Immunization With Varicella Vaccine at Different Intervals
NCT ID: NCT06994052
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
412 participants
INTERVENTIONAL
2024-09-21
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A
Participants received a single dose of varicella vaccine as booster immunization 3 months after their primary vaccination.
Varicella vaccine
lyophilized powder, subcutaneous injection
Group B
Participants received a single dose of varicella vaccine as booster immunization 18-30 months after their primary vaccination.
Varicella vaccine
lyophilized powder, subcutaneous injection
Group C
Participants received a single dose of varicella vaccine as booster immunization 36-48 months after their primary vaccination.
Varicella vaccine
lyophilized powder, subcutaneous injection
Group D
Participants received a single dose of varicella vaccine as booster immunization 60-72 months after their primary vaccination.
Varicella vaccine
lyophilized powder, subcutaneous injection
Interventions
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Varicella vaccine
lyophilized powder, subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Has previously received a single dose of varicella vaccine, with at least 3 months since the first dose;
* The subject or legal guardian can understand and sign the informed consent form (double signature is required for those over 8 years old);
* Participants and their legal guardians voluntarily participate in the study and are able to comply with all study procedures;
* Provide legal identity proof;
Exclusion Criteria
* History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioedema, dyspnea, etc.);
* Suffering from acute disease, severe chronic disease, acute exacerbation of chronic disease;
* With any confirmed or suspected immunodeficiency disease, immunocompromised or receiving immunosuppressive therapy (including systemic steroid therapy);
* With a history of congenital immune diseases or close contact with family members with a history of congenital immune diseases;
* With encephalopathy, uncontrolled epilepsy, other progressive neurological disorders, history of Guillain-Barre syndrome;
* Body temperature \>37℃ at the time of vaccination;
* Receipt of blood products within 3 months before receiving investigational vaccine;
* Receipt of another study drug within 30 days before receipt of the investigational vaccine;
* Receipt of live attenuated vaccine within 28 days before receipt of investigational vaccine;
* Receipt of subunit or inactivated vaccine within 7 days before receipt of investigational vaccine;
* Participated in other clinical trials before enrollment and were enrolled in another clinical trial during the follow-up period or planned to participate in another clinical trial within 3 months;
* The participant had any other factors that were ineligible for vaccination by in the investigator's judgment.
7 Years
12 Years
ALL
Yes
Sponsors
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Sinovac (Dalian) Vaccine Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Jiangsu Provincial Center for Disease control and Prevention
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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PRO-VAR-MA4004-JS-1
Identifier Type: -
Identifier Source: org_study_id
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