Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX

Encephalitis Clinical Trial

Official title:

Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose After a Primary Vaccination With CD.JEVAX in Thai Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526550
• Other study ID #: JEC26-EXT
• Status: Completed
• Phase: Phase 4
• First received: August 9, 2015
• Last updated: August 17, 2015
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study was undertaken to assess the immunogenicity and safety of a booster dose of JE-CV after primary vaccination with SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.

Description:

The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GSK) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• Children aged 1 to <5 years on the day of inclusion

• History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment

• In good general health at the time of inclusion

• Provision of informed consent by the parent(s) or legal guardian(s)

Exclusion Criteria:

• Receipt of blood or blood products in the past 3 months

• Acute febrile illness on the day of vaccination (Body Temperature = 38 ?C)

• Previous receipt of 2 doses of any vaccine against JE virus

• Known hypersensitivity to any of the vaccine components

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

• Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis

Intervention

Biological:
• Live attenuated chimeric Japanese Encephalitis vaccine
0.5 mL dose containing = 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
• Inactivated Hepatitis A vaccine
0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Siriraj Hospital	Sanofi Pasteur, a Sanofi Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 days post vaccination	Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).	Day 0 (Baseline) and Day 28 (post-vaccination)	No
Secondary	Change from Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 days post vaccination	Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer =10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.	Day 0 (Baseline) and Day 28 (post-vaccination)	No
Secondary	Number of participants reporting immediate reactions, solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events following vaccination With IMOJEV™	Solicited injection site: Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability and Rash.	Up to 28 days post booster vaccination	Yes