Varicella
Conditions
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.
Interventions
BIOLOGICALHBV-3
Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month
BIOLOGICALHBV-6
Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month
BIOLOGICALvaricella-3
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month
BIOLOGICALvaricella-6
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month
Sponsors
Beijing Center for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who have adverse reaction | 1 year | The safety is evaluated by systemic and local reaction after each vaccination. |
Other
| Measure | Time frame |
|---|---|
| Number of participants who catch chickenpox | 3 years |
Countries
China
Contacts
Primary ContactNianmin Shi
Backup ContactLi Li
Outcome results
None listed