Who is sponsoring NCT01396512?

NCT01396512 is sponsored by Sanofi Pasteur, a Sanofi Company.

What condition does NCT01396512 study?

NCT01396512 studies Japanese Encephalitis, Japanese Encephalitis Virus Disease.

What drugs are being tested in NCT01396512?

Interventions: Live attenuated Japanese encephalitis chimeric virus vaccine, Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine).

What is the status of NCT01396512?

NCT01396512 is currently COMPLETED.

Last reviewed 2014-03-24 · How we verify

Immunogenicity and Safety of a Single Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) in Comparison With a Single Dose of SA14-14-2 Vaccine (CD.JEVAX™, Chengdu Institute of Biological Products, China) Administered in Healthy Toddlers in South-Korea

NCT01396512 Phase 3 COMPLETED Results posted

The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine \[CD.JEVAX™\]) after a single dose vaccination to support product registration. Primary Objective: * To demonstrate the non-inferiority of the antibody response 28 days after administration of one dose of IMOJEV™ compared to the antibody response 28 days after administration of one dose of the CD.JEVAX™ control vaccine. Secondary Objectives: * To describe the immune response to Japanese encephalitis (JE) in both vaccine groups using 50% plaque reduction neutralization assay (PRNT50) assays before and after a single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine. * To describe the safety of vaccination in all subjects up to 28 days and all serious adverse events up to 6-month after vaccination.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 3
Status	COMPLETED
Enrolment	274
Start date	2011-07
Completion	2013-06

Conditions

Japanese Encephalitis
Japanese Encephalitis Virus Disease

Interventions

Live attenuated Japanese encephalitis chimeric virus vaccine
Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)

Primary outcomes

Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine — Day 28 post-vaccination
Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (\<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.

Countries

South Korea