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

Beijing Center for Disease Prevention and Control

Status and phase: Unknown; Phase 4

Conditions: Varicella

Treatments: Biological: varicella-3; Biological: HBV-3; Biological: HBV-6; Biological: varicella-6

Study type: Interventional

Funder types: Other

Identifiers

NCT01866566

BJCDPC-9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 1 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,800 participants in 4 patient groups, including a placebo group

HBV-3

Placebo Comparator group

Description:

one dose HBV

Treatment:

Biological: HBV-3

HBV-6

Placebo Comparator group

Description:

one dose HBV

Treatment:

Biological: HBV-6

varicella-3

Experimental group

Description:

2 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time

Treatment:

Biological: varicella-3

varicella-6

Experimental group

Description:

2 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time

Treatment:

Biological: varicella-6