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

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ClinicalTrials.gov Identifier: NCT02492165
Recruitment Status : Completed
First Posted : July 8, 2015
Results First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Collaborator:
National Institute of Hygiene and Epidemiology, Vietnam
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE July 5, 2015
First Posted Date  ICMJE July 8, 2015
Results First Submitted Date  ICMJE October 4, 2016
Results First Posted Date  ICMJE November 29, 2016
Last Update Posted Date November 29, 2016
Study Start Date  ICMJE June 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • 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 test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).
  • Percentage of Participants With Japanese Encephalitis Seroconversion 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 test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.
  • Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies 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 test (PRNT50).
Original Primary Outcome Measures  ICMJE
 (submitted: July 5, 2015)
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
Change History Complete list of historical versions of study NCT02492165 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2015)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects
Official Title  ICMJE 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 Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Japanese Encephalitis
Intervention  ICMJE Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
0.5 mL, Subcutaneous
Other Name: IMOJEV®
Study Arms  ICMJE
  • Experimental: Age 9 Months through 4 Years Group
    Participants age 9 Months through 4 Years old at enrollment
    Intervention: Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
  • Experimental: Age 5 Years through 11 Years Group
    Participants age 5 Years through 11 Years old at enrollment
    Intervention: Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
  • Experimental: Age 12 Years through 17 Years Group
    Participants age 12 Years through 17 Years old at enrollment
    Intervention: Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
  • Experimental: Age 18 Years through 60 Years Group
    Participants age 18 Years through 60 Years old at enrollment
    Intervention: Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
Publications * Vu TD, Nguyen QD, Tran HTA, Bosch-Castells V, Zocchetti C, Houillon G. Immunogenicity and safety of a single dose of a live attenuated Japanese encephalitis chimeric virus vaccine in Vietnam: A single-arm, single-center study. Int J Infect Dis. 2018 Jan;66:137-142. doi: 10.1016/j.ijid.2017.10.010. Epub 2017 Nov 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2015)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 9 months through 60 years on the day of inclusion.
  • For adults: Informed consent form has been signed and dated by the subject. For minors: Informed consent form has been signed and dated by the parent or legally acceptable representative. In addition, in accordance with the Institution Ethics Committee / Institution Review Board requirements and as appropriate for the age of the subject, the subject may be required to sign and date the informed consent form if aged 12 to 17 years or assent form if aged 8 to 11 years.
  • Subject and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and comply with all study procedures.

Exclusion Criteria:

  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).
  • Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure.
  • Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination, except for inactivated influenza vaccination, which may be received at least 2 weeks before the study vaccine
  • Previous vaccination against flavivirus disease, including Japanese Encephalitis (JE), dengue, and yellow fever.
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months that might interfere with the assessment of the immune response.
  • 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 (for more than 2 consecutive weeks within the 4 weeks preceding vaccination).
  • History of flavivirus infection (confirmed either clinically, serologically, or virologically).
  • History of central nervous system disorder or disease, including seizures.
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances.
  • Known thrombocytopenia, contraindicating vaccination.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating vaccination.
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Current alcohol abuse or drug addiction.
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
  • Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Receipt of any chronic anti-viral in the 2 months preceding the study vaccination or planned receipt of any anti-viral in the 4 weeks following the study vaccination. Short-term antiviral drugs for flu or herpes can be administered provided there is a wash-out period of 1 week before the administration of the vaccine.
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02492165
Other Study ID Numbers  ICMJE JEC13
U1111-1143-8142 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi".
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE National Institute of Hygiene and Epidemiology, Vietnam
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur SA
PRS Account Sanofi
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP