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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
Shanghai Municipal Center for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella focused on measuring varicella vaccination

Eligibility Criteria

1 Year - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

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
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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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