Safety and immunogenicity of a live attenuated SA14-14-2 JE Vaccine (CD.JEVAX®) as a booster dose after priming with chimeric JE Vaccine (IMOJEV®) in Thai childre
- Conditions
- Safety and immunogenicity of a live attenuated SA14ᆢDŽ JE VaccineJapanese EncephalitisLive AttenuatedVaccine
- Registration Number
- TCTR20151213001
- Lead Sponsor
- Chengdu Institute of Biological Products, Chengdu, PR China
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method