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

This study has been completed.
Sponsor:
Collaborator:
Guangdong Provincial Institute of Biological Products And Materia Medica
Information provided by (Responsible Party):
Changchun Keygen Biological Products Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01817270
First received: March 4, 2013
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Chickenpox
Biological: Live Attenuated Varicella Vaccine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine

Resource links provided by NLM:


Further study details as provided by Changchun Keygen Biological Products Co., Ltd.:

Primary Outcome Measures:
  • Seroconversion rate and GMTs for live attenuated varicella vaccine [ Time Frame: 35-42 days after the first and second doses ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: within 30 days after each vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 368
Study Start Date: March 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
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 ≤ 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817270

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

No publications provided

Responsible Party: Changchun Keygen Biological Products Co., Ltd.
ClinicalTrials.gov Identifier: NCT01817270     History of Changes
Other Study ID Numbers: NCT02038506
Study First Received: March 4, 2013
Last Updated: October 14, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 23, 2014