A Clinical Trial in Healthy Infants to Assess Lot-to-lot Consistency of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine Manufactured in a New Good Manufacturing Practices Facility and Non-inferiority With Respect to an Earlier Product.

NCT01635816 Phase 4 COMPLETED

The proposed Japanese Encephalitis (JE)Vaccine study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of JE live attenuated SA 14-14-2 vaccine manufactured in a new GMP facility, and to establish non-inferiority of the new vaccine in comparison to a single lot of the same vaccine manufactured in the existing facility. The study will enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, JEV05 will provide local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This will be the first step to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.

Details

Lead sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh
Phase	Phase 4
Status	COMPLETED
Enrolment	1000
Start date	2012-05
Completion	2012-12

Conditions

• Healthy Infants

Interventions

• JE Vaccine existing facility
• JE vaccine new plant lot 1
• JE vaccine new plant lot 2
• JE vaccine new plant lot 3

Primary outcomes

• Immunogenicity of different lots of vaccines — 8 months
  JE immunogenicity will be parameterized as the percentage of children with demonstrated seroprotection (defined as a serum antibody titer of ≥ 1:10 as measured by PRNT) at 28 days post-immunization with JE live attenuated SA 14-14-2 vaccine.

Countries

Bangladesh