Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
NCT ID: NCT02146469
Last Updated: 2014-05-23
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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UNKNOWN
PHASE4
1200 participants
INTERVENTIONAL
2012-12-31
2014-12-31
Brief Summary
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1. To know the antibody level during different interval after received 1 dose varicella vaccine.
2. To know safety and effectiveness of received 2 doses varicella vaccine with different interval.
3. To know safety and effectiveness of received varicella vaccine and MMR at the same time.
To achieve that, this study selects children with specific varicella vaccine history, gives 1 or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after vaccination.
All blood specimens will be tested by a third-party detection institution.
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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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None varicella vaccine history
2 doses with an 3 months interval
2 doses with an 3 months interval
varicella vaccination
1 year after first dose
A second dose with an 1 year interval
A second dose with an 1 year interval
varicella vaccine
3 years after first dose
A second dose with an 3 year interval
A second dose with an 3 year interval
varicella vaccine
5 years after first dose
A second dose with an 5 year interval
A second dose with an 5 year interval
varicella vaccine
Testing group for conbined immunization
1 dose Varicella vaccine and 1 dose MMR given at the same time
1 dose Varicella vaccine and 1 dose MMR given at the same time
varicella vaccine and MMR
Control group for conbined immunization
1 dose MMR
1 dose MMR
MMR
Interventions
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2 doses with an 3 months interval
varicella vaccination
A second dose with an 1 year interval
varicella vaccine
A second dose with an 3 year interval
varicella vaccine
A second dose with an 5 year interval
varicella vaccine
1 dose Varicella vaccine and 1 dose MMR given at the same time
varicella vaccine and MMR
1 dose MMR
MMR
Eligibility Criteria
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Inclusion Criteria
* Without a previous history of varicella
* With an axillary temperature ≤37.5℃ at the time of vaccination
* Appropriate varicella vaccination history
* With guardian signing the informed consent and available for clinical observation
Exclusion Criteria
* With acute illness, severe or acute attack of chronic illness or fever
* With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs
* Suffering a brain disease, uncontrolled epilepsy or progressive nerve system disease
* With a family or personal history of seizure, chronic illness, epilepsy or allergy
* With unknown immunization history or unable to follow the immunization schedule of EPI
* Received any vaccine within 4 weeks or willing to receive any vaccine in 1 month
* With hemorrhagic tendency or prolonged period of bleeding
* Received whole blood, plasma or immunoglobulin within 5 months
* Received systemic antibiotics or antiviral treatment for acute illness within 7 days
* With an axillary temperature ≥38℃ within 3 days
* Participating in another clinical trial
* Any situation that might influence the consequence of the clinical trial
1 Year
7 Years
ALL
Yes
Sponsors
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Shanghai Institute Of Biological Products
INDUSTRY
Shanghai Municipal Center for Disease Control and Prevention
OTHER
Responsible Party
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Principal Investigators
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Xiaodong Sun
Role: STUDY_DIRECTOR
Shanghai Municipal Center for Disease Control and Prevention
Locations
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Shanghai municipal center for disease control and prevention
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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SH2012VAR
Identifier Type: -
Identifier Source: org_study_id
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