Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers

Japanese Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396512
• Other study ID #: JEC12
• Secondary ID: U1111-1117-7378
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2011
• Last updated: March 24, 2014
• Start date: July 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0) and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed from day of vaccination and up to 6 months post-vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 24 Months

Eligibility

Inclusion Criteria:

• Aged 12 to 24 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.

• Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria:

• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.

• Planned participation in another clinical trial during the present trial period.

• Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.

• Known systemic hypersensitivity to any of IMOJEV™ components or history of a life-threatening reaction to a vaccine containing any of the same substances and vaccination,known systemic hypersensitivity to CD.JEVAX® main components and the other components (including Gelatin, kanamycin, and gentamicin).

• 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 Visit 01 and up to the 4 weeks following the trial vaccination.

• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.

• Planned receipt of any vaccine from the inclusion up to the 4 weeks following the trial vaccination.

• History of central nervous system disorder or disease, including seizures.

• Planned receipt of any JE vaccine during the course of the study.

• History of flavivirus infection (confirmed either clinically, serologically or virologically).

• Administration of systemic corticosteroids for more than two consecutive weeks within the 4 weeks preceding vaccination.

• Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection 3 days before vaccination as well as the day of vaccination, according to Investigator judgment.

• Thrombocytopenia or bleeding disorder contraindicated for vaccination with same administration route, or receipt of anticoagulants in the 3 weeks preceding inclusion.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis
• Japanese Encephalitis Virus Disease
• Virus Diseases

Intervention

Biological:
• Live attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous
• Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)
0.5 mL, Subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine	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.	Day 28 post-vaccination	No
Secondary	Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine	Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).; JE-CV PRNT50 antibody titer >10 (1/dil, Day 0)	Day 0 (pre-vaccination) and Day 28 post-vaccination	No
Secondary	Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine	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 (pre-vaccination) and Day 28 post-vaccination	No
Secondary	Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine	Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter =50 mm. Grade 3 systemic reactions: Fever >39.5°C; Vomiting =6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses =3 feeds or most feeds; Irritability - inconsolable.	Day 0 up to Day 14 post-vaccination	No

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