Varicella
Conditions
Keywords
varicella vaccination
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.
Interventions
BIOLOGICAL2 doses with an 3 months interval
varicella vaccination
BIOLOGICALA second dose with an 1 year interval
varicella vaccine
BIOLOGICALA second dose with an 3 year interval
varicella vaccine
BIOLOGICALA second dose with an 5 year interval
varicella vaccine
BIOLOGICAL1 dose Varicella vaccine and 1 dose MMR given at the same time
varicella vaccine and MMR
BIOLOGICAL1 dose MMR
MMR
Sponsors
Shanghai Institute Of Biological Products
Shanghai Municipal Center for Disease Control and Prevention
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rate and GMCs after varicella vaccination | 35-42 days after each dose vaccination |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of Adverse Events Following Immunization | 30 days after each dose vaccination |
Countries
China
Outcome results
None listed