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

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT01092507

Purpose

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.

Condition	Intervention	Phase
Encephalitis Japanese Encephalitis	Biological: Japanese encephalitis chimeric virus vaccine (JE CV) Biological: Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	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 - Primary Vaccination and Long-term Follow-up to 5 Years Post-vaccination

Resource links provided by NLM:

MedlinePlus related topics: Encephalitis

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Immunogenicity in terms of seroconversion post-vaccination with Japanese encephalitis chimeric virus vaccine. [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety in terms of solicited injection site and systemic events, and serious adverse events (SAEs) after primary administration of Japanese encephalitis chimeric virus vaccine. [ Time Frame: 0-14 days and up to 12 months post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment:	300
Study Start Date:	March 2010
Study Completion Date:	October 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: JE-CV Group Participants will receive one dose of Japanese encephalitis chimeric virus vaccine (JE-CV)	Biological: Japanese encephalitis chimeric virus vaccine (JE CV) 0.5 mL, Subcutaneous
Active Comparator: SA14-14-2 vaccine Group Participants will receive one dose of Japanese encephalitis live vaccine, SA14-14-2 vaccine. (CD.JEVAX®)	Biological: Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®) 0.5 mL, Subcutaneous Other Name: CD.JEVAX®

Detailed Description:

All participants will receive one injection of their randomized vaccine on Day 0. Follow-up will continue for 12 months after vaccination.

Eligibility

Ages Eligible for Study:	9 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria :

Aged 9 to 18 months on the day of inclusion
In good general health, without significant medical history
Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations
Subject and parent/legally acceptable representatives able to attend all scheduled visits and comply with all trial procedures
Completion of vaccinations according to the national immunization schedule.

Exclusion Criteria :

Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of the immune response
Previous vaccination against flavivirus disease, including Japanese encephalitis (JE)
Administration of any anti-viral within 2 months preceding first vaccination and up to the 4 weeks following the last trial vaccination at Month 3
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
Planned receipt of any vaccine from the inclusion up to the 4 weeks following the last trial vaccination at Month 3
Planned receipt of any Japanese encephalitis vaccine during the course of the study (up to Year 5)
History of central nervous system disorder or disease, including seizures
History of flavivirus infection (confirmed either clinically, serologically or microbiologically)
Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092507

Locations

Thailand

Bangkok, Thailand, 10330

Bangkok, Thailand, 10700

Khon Kaen, Thailand, 40002

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT01092507 History of Changes
Other Study ID Numbers:	JEC07, UTN: U1111-1112-2269
Study First Received:	March 23, 2010
Last Updated:	October 10, 2011
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Encephalitis
Japanese Encephalitis
Japanese Encephalitis Vaccines
Infant

Additional relevant MeSH terms:

Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 23, 2012