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

Phase 4

• Conditions: Varicella
• Interventions: Biological: HBV-6; Biological: varicella-3; Biological: varicella-6; Biological: HBV-3

• Registration Number: NCT01866566
• Lead Sponsor: Beijing Center for Disease Control and Prevention

Brief Summary

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.

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 Timeline

• Status Verified: 2013-05
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-31
• Study Start: 2013-06
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26
• Primary Completion: 2014-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HBV-6	HBV-6	one dose HBV
varicella-3	varicella-3	2 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time
varicella-6	varicella-6	2 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time
HBV-3	HBV-3	one dose HBV

Primary Outcome Measures

Name	Time	Method
Antibody titer after 2 doses lived attenuated varicella vaccination	1 year	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

Name	Time	Method
Number of participants who have adverse reaction	1 year	The safety is evaluated by systemic and local reaction after each vaccination.

Trial Locations

Locations (1)

Shanxi Centers for Disease Control and Prevention; 🇨🇳 Yuncheng, Shanxi, China