Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
1 other identifier
interventional
1,200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2012
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
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 21, 2014
CompletedFirst Posted
Study publicly available on registry
May 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 23, 2014
May 1, 2014
1.5 years
May 21, 2014
May 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroconversion rate and GMCs after varicella vaccination
35-42 days after each dose vaccination
Secondary Outcomes (1)
The incidence of Adverse Events Following Immunization
30 days after each dose vaccination
Study Arms (6)
None varicella vaccine history
EXPERIMENTAL2 doses with an 3 months interval
1 year after first dose
EXPERIMENTALA second dose with an 1 year interval
3 years after first dose
EXPERIMENTALA second dose with an 3 year interval
5 years after first dose
EXPERIMENTALA second dose with an 5 year interval
Testing group for conbined immunization
EXPERIMENTAL1 dose Varicella vaccine and 1 dose MMR given at the same time
Control group for conbined immunization
PLACEBO COMPARATOR1 dose MMR
Interventions
varicella vaccine and MMR
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai municipal center for disease control and prevention
Shanghai, Shanghai Municipality, 021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xiaodong Sun
Shanghai Municipal Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2014
First Posted
May 23, 2014
Study Start
December 1, 2012
Primary Completion
June 1, 2014
Study Completion
December 1, 2014
Last Updated
May 23, 2014
Record last verified: 2014-05