Clinical trial NCT01866566: The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
Official title: Phase 4 Study of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Varicella
Lead sponsor: Beijing Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
First posted: 2013-05-31
Enrollment: 1800
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Antibody titer after 2 doses lived attenuated varicella vaccination
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants who have adverse reaction
timeFrame: 1 year
Other outcomes:
measure: Number of participants who catch chickenpox
timeFrame: 3 years
Locations:
city: Yuncheng
country: China
facility: Shanxi Centers for Disease Control and Prevention
state: Shanxi
Study officials:
affiliation: Beijing Chaoyang District Centers for Disease Control and Prevention
name: Nianmin Shi
role: STUDY_CHAIR
References: