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Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine

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ClinicalTrials.gov Identifier: NCT02173899
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : September 1, 2014
Sponsor:
Collaborator:
Guangdong Provincial Institute of Biological Products And Materia Medica
Information provided by (Responsible Party):
Changchun Keygen Biological Products Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Varicella Biological: varicella-1 Biological: varicella-3 Biological: varicella-5 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 716 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine
Study Start Date : June 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles

Arm Intervention/treatment
Experimental: varicella-1
The second varicella vaccine and 1 year of the interval time between 2 doses
Biological: varicella-1
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day

Experimental: varicella-3
The second varicella vaccine and 3 years of the interval time between 2 doses
Biological: varicella-3
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day

Experimental: varicella-5
The second varicella vaccine and 5 years of the interval time between 2 doses
Biological: varicella-5
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day




Primary Outcome Measures :
  1. Seroconversion rate and GMTs for live attenuated varicella vaccine [ Time Frame: 35-42 days after the second dose ]

Secondary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: within 30 days after the second dose ]


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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ≤ 7 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 antiviral 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173899


Locations
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China, Guangdong
Shenzhen Luohu District Center for Disease Control and Prevention
Shenzhen, Guangdong, China
Sponsors and Collaborators
Changchun Keygen Biological Products Co., Ltd.
Guangdong Provincial Institute of Biological Products And Materia Medica
Investigators
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Principal Investigator: Huizhen Zheng, Master Guangdong Center for Disease Prevention and Control

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Responsible Party: Changchun Keygen Biological Products Co., Ltd.
ClinicalTrials.gov Identifier: NCT02173899     History of Changes
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Chickenpox
Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs