Who is sponsoring NCT01092507?

NCT01092507 is sponsored by Sanofi Pasteur, a Sanofi Company.

What condition does NCT01092507 study?

NCT01092507 studies Encephalitis, Japanese Encephalitis.

What drugs are being tested in NCT01092507?

Interventions: Japanese encephalitis chimeric virus vaccine (JE-CV), Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®).

What is the status of NCT01092507?

NCT01092507 is currently COMPLETED.

Last reviewed 2013-11-30 · How we verify

A Controlled Study of the Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Comparison With SA14-14-2 Vaccine in Infants and Toddlers in Thailand

NCT01092507 Phase 3 COMPLETED Results posted

The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in infants and toddlers. Primary Objective: * To demonstrate the non-inferiority of the antibody response 28 days after vaccine administration of one dose of JE CV (administered on Day 0) compared to the antibody response after one dose of the SA14-14-2 control vaccine (administered on Day 0). Secondary Objectives: * To describe the immune response to JE in both vaccine groups in JE-CV virus and SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2 vaccine * To describe the safety profile in all vaccinated subjects up to 28 days and all serious adverse events (SAEs) up to 6 months after vaccination. * To describe only related SAEs and all death from 6 month to 12-month follow-up.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 3
Status	COMPLETED
Enrolment	300
Start date	2010-03
Completion	2011-10

Conditions

Encephalitis
Japanese Encephalitis

Interventions

Japanese encephalitis chimeric virus vaccine (JE-CV)
Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)

Primary outcomes

Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) — Day 0 through Day 28 after vaccination
Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50). Japanese Encephalitis seroconversion was defined as a pre-vaccination titer \<10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination.

Countries

Thailand