Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine

October 14, 2013 updated by: Changchun Keygen Biological Products Co., Ltd.

A Study to Evaluate the Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine

The purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

368

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
    • Guangdong
      • Yunfu, Guangdong, China
        • Xinxing 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 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
  • Participant is aged ≥ 1 year to ≤ 3 years
  • Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
  • Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
  • Body temperature ≤ 37.5℃

Exclusion Criteria:

  • Known allergy to any constituent of the vaccine
  • Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
  • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
  • Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
  • Failed to the Expanded Programme on Immunization(EPI)
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Plan to receive any vaccine in the 4 weeks following the trial vaccination
  • Known bleeding disorder
  • Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination
  • Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination
  • An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
  • Participation in any other interventional clinical trial
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Live Attenuated Varicella Vaccine
use the left arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
Biological: Live Attenuated Varicella Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seroconversion rate and GMTs for live attenuated varicella vaccine
Time Frame: 35-42 days after the first and second doses
35-42 days after the first and second doses

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse events
Time Frame: within 30 days after each vaccination
within 30 days after each vaccination

Collaborators and Investigators

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

Sponsor

Changchun Keygen Biological Products Co., Ltd.

Collaborators

Guangdong Provincial Institute of Biological Products And Materia Medica

Investigators

  • Principal Investigator: Huizhen Zheng, Master, Guangdong Center for Disease Prevention and Control

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

March 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 25, 2013

Study Record Updates

Last Update Posted (Estimate)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 14, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT02038506

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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