A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers

Summary

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.

Timeline

Start

2010-03

Primary completion

2011-09

Completion

2011-10

Outcome

Met primary endpoint

paper Noninferiority was demonstrated as the difference between the JE-CV and SA14-14-2 groups was -0.012 percentage points PMID 24717964 ↗

paper which was above the required -10%. PMID 24717964 ↗

Publications

• Feroldi E, Pancharoen C, Kosalaraksa P, Chokephaibulkit K, Boaz M, Meric C, Hutagalung Y, Bouckenooghe A. Primary immunization of infants and toddlers in Thailand with Japanese encephalitis chimeric virus vaccine in comparison with SA14-14-2: a randomized study of immunogenicity and safety. Pediatr Infect Dis J. 2014 Jun;33(6):643-9. doi: 10.1097/INF.0000000000000276.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Japanese encephalitis chimeric virus vaccine	Vaccine	0.5 ml	Subcutaneous
Comparator	SA14-14-2 vaccine	Vaccine	0.5 ml	Subcutaneous

Indications