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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine [ Time Frame: Day 28 post-vaccination ]

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.


Original Primary Outcome: Information on the immunogenicity of live attenuated Japanese encephalitis chimeric virus vaccine after single dose vaccination [ Time Frame: 28 days post-vaccination ]

Immune response will be determined by 50% plaque reduction neutralization test assays


Current Secondary Outcome:

  • Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

    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)

  • Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 28 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.
  • Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine [ Time Frame: Day 0 up to Day 14 post-vaccination ]
    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.


Original Secondary Outcome:

  • Number of participants reporting solicited injection site reactions, solicited systemic reactions and unsolicited systemic adverse events (AEs) following vaccination with either IMOJEV™ or CD.JEVAX™ [ Time Frame: Day 0 and up to Day 28 post-vaccination ]
    Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and Irritability.
  • Number of participants reporting serious adverse events (SAE) following vaccination with either IMOJEV™ or CD.JEVAX™ [ Time Frame: Up to 6-month post-vaccination ]

    An SAE is defined as any untoward medical occurrence that at any dose (including overdose):

    • Results in death
    • Is life-threatening
    • Requires inpatient hospitalization or prolongation of existing hospitalization
    • Results in persistent or significant disability/incapacity
    • Is a congenital anomaly/birth defect
    • Is an important medical event.


Information By: Sanofi

Dates:
Date Received: July 14, 2011
Date Started: July 2011
Date Completion:
Last Updated: March 24, 2014
Last Verified: March 2014