The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Beijing Center for Disease Control and Prevention
Sponsor:
Information provided by (Responsible Party):
Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01866566
First received: May 28, 2013
Last updated: June 25, 2013
Last verified: May 2013
  Purpose

Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management.


Condition Intervention Phase
Varicella
Biological: HBV-3
Biological: HBV-6
Biological: varicella-3
Biological: varicella-6
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 4 Study of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination

Resource links provided by NLM:


Further study details as provided by Beijing Center for Disease Control and Prevention:

Primary Outcome Measures:
  • Antibody titer after 2 doses lived attenuated varicella vaccination [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Serums are collected from all participants before and 42 days after the first vaccination, and also 42 days after the second vaccination. The antibody titer to Varicella was detected through FAMA test.


Secondary Outcome Measures:
  • Number of participants who have adverse reaction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The safety is evaluated by systemic and local reaction after each vaccination.


Other Outcome Measures:
  • Number of participants who catch chickenpox [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: June 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: HBV-3
one dose HBV
Biological: HBV-3
Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month
Placebo Comparator: HBV-6
one dose HBV
Biological: HBV-6
Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month
Experimental: varicella-3
2 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time
Biological: varicella-3
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month
Experimental: varicella-6
2 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time
Biological: varicella-6
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month

Detailed Description:

Healthy participants aged 1 to 12 years old who had never received Varicella Vaccine are divided into three age groups, 1 to 3 years old group, 4 to 6 years old group and 7-12 years old group. In each age group, participants are randomly divided into experiment group and control groups.

  Eligibility

Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Participants from Shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, physical examination, clinical judgment of the investor.

Exclusion Criteria:

  1. Having a fever (axillary temperature>37.0℃) before enrollment;
  2. Having a disease history of seizures, brain disease and the vaccination history of allergies and convulsions;
  3. Antibiotics allergy;
  4. Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder;
  5. Having immunodeficiency or under immunosuppression therapy, radiation therapy;
  6. Having respiratory diseases, acute infection, chronic disease and HIV infection;
  7. Having systemic skin rash, skin tinea, herpes;
  8. Chronic liver and kidney disease;
  9. Heart disease, and severe hypertension;
  10. Have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment;
  11. Have received other live attenuated vaccine vaccination in 30 days before enrollment;
  12. Had been infected with Varicella virus and displayed symptom;
  13. Have received one or two dose of Varicella vaccine before enrollment;
  14. Congenital malformations, growth disorders such as Down's syndrome, diabetes, sickle cell anemia and nervous disorders
  15. Guillain-barre syndrome
  16. Thyroid resection history or thyroid disease treatment in the past 12 months;
  17. Asthma
  18. Have participated in other clinical research;
  19. Have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.
  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: NCT01866566

Contacts
Contact: Nianmin Shi 86-010-67773550 cycdc2011@163.com
Contact: Li Li

Locations
China, Shanxi
Shanxi Centers for Disease Control and Prevention Recruiting
Yuncheng, Shanxi, China
Contact: Li         
Principal Investigator: Guohua Li         
Sponsors and Collaborators
Beijing Center for Disease Control and Prevention
Investigators
Study Chair: Nianmin Shi Beijing Chaoyang District Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01866566     History of Changes
Other Study ID Numbers: BJCDPC-9
Study First Received: May 28, 2013
Last Updated: June 25, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014