NCT01567865

Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 818 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 10 Months – 12 Months
• Healthy volunteers: Accepted

Summary

The proposed 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 Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured in a new good manufacture practice (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 aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, this study provided local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is 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.

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Vaccine produced in existing facility	Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
BIOLOGICAL	Vaccine produced in new facility	Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-03-30
• Last updated: 2018-12-05
• Results posted: 2018-11-13

Locations

1 site across 1 country: Bangladesh