Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
Phase 4
- Conditions
- Varicella
- Registration Number
- NCT02146469
- Lead Sponsor
- Shanghai Municipal Center for Disease Control and Prevention
- Brief Summary
The objective of the study is as follows:
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1200
Inclusion Criteria
- Aged 1 to 7
- 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
- Hypersensitive to any active substance of the vaccine including excipients and antibiotics
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Seroconversion rate and GMCs after varicella vaccination 35-42 days after each dose vaccination
- Secondary Outcome Measures
Name Time Method The incidence of Adverse Events Following Immunization 30 days after each dose vaccination
Trial Locations
- Locations (1)
Shanghai municipal center for disease control and prevention
🇨🇳Shanghai, Shanghai, China
Shanghai municipal center for disease control and prevention🇨🇳Shanghai, Shanghai, China