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

Phase 4 Study of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination

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.

Study Overview

• Status: Unknown
• Conditions: Varicella
• Intervention / Treatment: Biological: HBV-3; Biological: HBV-6; Biological: varicella-3; Biological: varicella-6

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1800
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Yuncheng, Shanxi, China
      • Recruiting
      • Shanxi Centers for Disease Control and Prevention
      • Contact: Li
      • Principal Investigator: Guohua Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody titer after 2 doses lived attenuated varicella vaccination	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who have adverse reaction	The safety is evaluated by systemic and local reaction after each vaccination.	1 year

Other Outcome Measures

Outcome Measure	Time Frame
Number of participants who catch chickenpox	3 years

Collaborators and Investigators

• Sponsor: Beijing Center for Disease Control and Prevention
• Investigators: Study Chair: Nianmin Shi, Beijing Chaoyang District Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): June 26, 2013
• Last Update Submitted That Met QC Criteria: June 25, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Chickenpox
• Other Study ID Numbers: BJCDPC-9