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

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01866566
• Other study ID #: BJCDPC-9
• Status: Recruiting
• Phase: Phase 4
• First received: May 28, 2013
• Last updated: June 25, 2013
• Start date: June 2013
• Est. completion date: January 2016

Study information

• Verified date: May 2013
• Source: Beijing Center for Disease Control and Prevention
• Contact: Nianmin Shi
• Phone: 86-010-67773550
• Email: cycdc2011[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: January 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• HBV-3
Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month
• HBV-6
Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month
• varicella-3
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month
• varicella-6
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month

Locations

Country	Name	City	State
China	Shanxi Centers for Disease Control and Prevention	Yuncheng	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants who catch chickenpox		3 years	No
Primary	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	No
Secondary	Number of participants who have adverse reaction	The safety is evaluated by systemic and local reaction after each vaccination.	1 year	Yes