Who is sponsoring NCT01567865?

NCT01567865 is sponsored by PATH.

What condition does NCT01567865 study?

NCT01567865 studies Japanese Encephalitis.

What drugs are being tested in NCT01567865?

Interventions: Vaccine produced in existing facility, Vaccine produced in new facility.

What is the status of NCT01567865?

NCT01567865 is currently COMPLETED.

Last reviewed 2018-11-12 · How we verify

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.

NCT01567865 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	PATH
Phase	Phase 4
Status	COMPLETED
Enrolment	818
Start date	2012-05
Completion	2012-12

Conditions

Japanese Encephalitis

Interventions

Vaccine produced in existing facility
Vaccine produced in new facility

Primary outcomes

Number/Percentage of Subjects With Demonstrated Seroprotection — 28 days post-vaccination
Seroprotection was defined as a serum antibody titer equal to or greater than 1:10, as measured by Plaque reduction neutralization test (PRNT). The end point for neutralization was the highest dilution of serum reducing the number of plaques by 50%, compared with a negative serum control. In 2004, a group of experts under the leadership of the WHO recommended that seroprotection (SP) against JEV be defined as a neutralizing anti-JEV antibody serum titer ≥1:10 as determined by PRNT \[Hombach et al. 2005\]. Accordingly, a titer of ≥1:10 was adopted as an indicator of seroprotection in this study.
Geometric Mean Titers (GMT) — 28 days post-vaccination
Geometric Mean Titers of Neutralizing anti-JEV antibody

Countries

Bangladesh