Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine

May 21, 2014 updated by: Shanghai Municipal Center for Disease Control and Prevention

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 021
        • Shanghai Municipal Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: None varicella vaccine history
2 doses with an 3 months interval
Biological: 2 doses with an 3 months interval
varicella vaccination
Experimental: 1 year after first dose
A second dose with an 1 year interval
Biological: A second dose with an 1 year interval
varicella vaccine
Experimental: 3 years after first dose
A second dose with an 3 year interval
Biological: A second dose with an 3 year interval
varicella vaccine
Experimental: 5 years after first dose
A second dose with an 5 year interval
Biological: A second dose with an 5 year interval
varicella vaccine
Experimental: Testing group for conbined immunization
1 dose Varicella vaccine and 1 dose MMR given at the same time
Biological: 1 dose Varicella vaccine and 1 dose MMR given at the same time
varicella vaccine and MMR
Placebo Comparator: Control group for conbined immunization
1 dose MMR
Biological: 1 dose MMR
MMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seroconversion rate and GMCs after varicella vaccination
Time Frame: 35-42 days after each dose vaccination
35-42 days after each dose vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of Adverse Events Following Immunization
Time Frame: 30 days after each dose vaccination
30 days after each dose vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Municipal Center for Disease Control and Prevention

Collaborators

Shanghai Institute Of Biological Products

Investigators

  • Study Director: Xiaodong Sun, Shanghai Municipal Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH2012VAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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