Clinical Trial: Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

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

Official Title: Immunogenicity and Safety of a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given to Healthy Subjects in Vietnam

Brief Summary:

The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity, reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data from other Asian pediatric populations.

Primary objective:

- To describe the safety profile of a single dose of IMOJEV®.

Secondary objectives:

  • To evaluate the immune response to JE 28 days after the administration of a single dose of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.

Detailed Summary: Study participants will be enrolled by age group and will each receive one injection of IMOJEV® on Day 0 given as primary vaccination. They will be assessed for immunogenicity and safety, post-vaccination.
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome:

  • Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) [ Time Frame: Day 0 up to Day 14 post-vaccination ]

    Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia.

    Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or >100 mm (≥ 12 years).

    Grade 3 Fever, > 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity.

  • Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]
    Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization

    Original Primary Outcome: Number of subjects reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial [ Time Frame: Day 0 through Day 28 post vaccination ]

    Solicited injection site reactions: Aged < 23 Months Tenderness, Redness, and Swelling. Aged 2 Years and above: Pain Redness and swelling; Solicited systemic reactions: Aged < 23 Months Fever (Temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and Irritability; and unsolicited adverse events. Aged 2 Years and above Fever (Temperature), Headache, Malaise and Myalgia


    Current Secondary Outcome:

    Original Secondary Outcome:

    • Neutralizing antibody titers at baseline and following as IMOJEV® vaccination [ Time Frame: Day 0 and Day 28 post vaccination ]
      The presence of neutralizing antibodies will be measured in all available sera using a JE chimeric virus 50% plaque reduction neutralization test (PRNT50)
    • Number of participants with seroconversion following IMOJEV® primary vaccination [ Time Frame: Day 0 and Day 28 post vaccination ]
      Seroconversion is defined as JE virus neutralizing antibody titers ≥ 10 (1/dil) in subjects who are seronegative (< 10 [1/dil]) at baseline and by a ≥ 4 fold rise in neutralizing antibody titers in subjects who are seropositive (≥ 10 [1/dil]) at baseline
    • Seroprotection status for antibody levels against JE virus before and after primary IMOJEV® vaccination [ Time Frame: Day 0 and Day 28 post vaccination ]
      Seroprotection defined as IMOJEV® neutralizing antibody titer ≥ 10 (1/dil)


    Information By: Sanofi

    Dates:
    Date Received: July 5, 2015
    Date Started: June 2015
    Date Completion:
    Last Updated: October 4, 2016
    Last Verified: October 2016