Safety and immunogenicity of a live attenuated SA14-
Conditions
Interventions
Sponsors
Chengdu Institute of Biological Products, Chengdu, PR China
Queen Sirikit National Institute of Child Health
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: A. aged 1-5 years. B. Have been vaccinated against encephalitis JE kind IMOJEV just a single dose at least 12 months and have never been vaccinated against encephalitis JE other. C. Be healthy according to history And physical examination by a physician D. Can pursue a research project in about 28-35 days. E. Signed a consent form to participate as a volunteer voluntarily. The parent or legal guardian legitimacy of volunteers. F. Not received any vaccine within 30 days prior to enrollment.
Exclusion criteria
Exclusion criteria: A. Volunteers have been vaccinated against encephalitis JE other. Except IMOJEV® B. Volunteers receive any vaccine within 30 days prior to enrollment. C. Volunteer allergy to any vaccine component. D. Volunteers are malaise thermometer ≥38º C in the armpit on the project. E. Volunteers receive blood or blood products within 3 months prior to enrollment or expects to receive blood or blood products within one month after receiving the vaccine. F. Volunteers or suspected immune deficiency. Including severe liver disease, kidney failure, cancer, autoimmune diseases would not grow themselves, the use of immunosuppressants, the use of steroids edible. (Except the steroid spray of respiratory tract) G. Any clinical situation in which doctors are of the opinion that the project may be a barrier to education, and interpretation of research results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and immunogenicity of a live attenuated SA14-14-2 JE Vaccine Upon enrollment Non-Paramatric | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of Immunotherapy with educational information in the past, and safety assessment Upon enrollment Compare children who received the live attenuated SA14-14-2 JE Vaccine | — |
Countries
Thailand
Contacts
Public ContactTawee Chotpitayasunondh
QSNICH
Outcome results
None listed