Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
Primary Purpose
Varicella
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
2 doses with an 3 months interval
A second dose with an 1 year interval
A second dose with an 3 year interval
A second dose with an 5 year interval
1 dose Varicella vaccine and 1 dose MMR given at the same time
1 dose MMR
Sponsored by
About this trial
This is an interventional prevention trial for Varicella focused on measuring varicella vaccination
Eligibility Criteria
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
Sites / Locations
- Shanghai municipal center for disease control and prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
None varicella vaccine history
1 year after first dose
3 years after first dose
5 years after first dose
Testing group for conbined immunization
Control group for conbined immunization
Arm Description
2 doses with an 3 months interval
A second dose with an 1 year interval
A second dose with an 3 year interval
A second dose with an 5 year interval
1 dose Varicella vaccine and 1 dose MMR given at the same time
1 dose MMR
Outcomes
Primary Outcome Measures
Seroconversion rate and GMCs after varicella vaccination
Secondary Outcome Measures
The incidence of Adverse Events Following Immunization
Full Information
NCT ID
NCT02146469
First Posted
May 21, 2014
Last Updated
May 21, 2014
Sponsor
Shanghai Municipal Center for Disease Control and Prevention
Collaborators
Shanghai Institute Of Biological Products
1. Study Identification
Unique Protocol Identification Number
NCT02146469
Brief Title
Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
Official Title
Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Municipal Center for Disease Control and Prevention
Collaborators
Shanghai Institute Of Biological Products
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the study is as follows:
To know the antibody level during different interval after received 1 dose varicella vaccine.
To know safety and effectiveness of received 2 doses varicella vaccine with different interval.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella
Keywords
varicella vaccination
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
None varicella vaccine history
Arm Type
Experimental
Arm Description
2 doses with an 3 months interval
Arm Title
1 year after first dose
Arm Type
Experimental
Arm Description
A second dose with an 1 year interval
Arm Title
3 years after first dose
Arm Type
Experimental
Arm Description
A second dose with an 3 year interval
Arm Title
5 years after first dose
Arm Type
Experimental
Arm Description
A second dose with an 5 year interval
Arm Title
Testing group for conbined immunization
Arm Type
Experimental
Arm Description
1 dose Varicella vaccine and 1 dose MMR given at the same time
Arm Title
Control group for conbined immunization
Arm Type
Placebo Comparator
Arm Description
1 dose MMR
Intervention Type
Biological
Intervention Name(s)
2 doses with an 3 months interval
Intervention Description
varicella vaccination
Intervention Type
Biological
Intervention Name(s)
A second dose with an 1 year interval
Intervention Description
varicella vaccine
Intervention Type
Biological
Intervention Name(s)
A second dose with an 3 year interval
Intervention Description
varicella vaccine
Intervention Type
Biological
Intervention Name(s)
A second dose with an 5 year interval
Intervention Description
varicella vaccine
Intervention Type
Biological
Intervention Name(s)
1 dose Varicella vaccine and 1 dose MMR given at the same time
Intervention Description
varicella vaccine and MMR
Intervention Type
Biological
Intervention Name(s)
1 dose MMR
Intervention Description
MMR
Primary Outcome Measure Information:
Title
Seroconversion rate and GMCs after varicella vaccination
Time Frame
35-42 days after each dose vaccination
Secondary Outcome Measure Information:
Title
The incidence of Adverse Events Following Immunization
Time Frame
30 days after each dose vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Sun
Organizational Affiliation
Shanghai Municipal Center for Disease Control and Prevention
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai municipal center for disease control and prevention
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
021
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
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