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Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01190228
Collaborator
(none)
454
Enrollment
1
Location
3
Arms
61.6
Actual Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to investigate the memory immune response and the yearly persistence of the immunity against Japanese Encephalitis (JE) after vaccination with Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in participants previously vaccinated with JE-CV vaccine.

Objectives:

  • To describe JE immune status before and after JE-CV vaccination in subjects previously vaccinated with JE-CV vaccine

  • To describe the immune status before and after JE-CV vaccination in JE-naïve control subjects.

  • To describe the safety (in terms of solicited and unsolicited adverse events) of a single dose of JE-CV vaccine up to 6 months after the last vaccination.

  • To describe all related serious adverse events (SAEs) and related deaths from 6 months to 5 years after vaccination in JE-CV-primed subjects.

Condition or Disease Intervention/Treatment Phase
  • Biological: JE-CV Vaccine
  • Biological: Varicella Vaccine
 Phase 3

Detailed Description

Study participants who are previously immunized with JE-CV vaccine will receive a booster dose of the JE-CV vaccine and will be followed up for 5 years for immunogenicity.

The control (JE-CV naïve) participants will receive either one dose of JE-CV vaccine or one dose of varicella vaccine.

All participants will be monitored for safety for 6 month post-vaccination.

Study Design

Study Type:
Interventional
Actual Enrollment :
454 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This was an open, controlled, multicenter, Phase III trial. Participants in Group 1 were previously vaccinated at 12 to 18 months of age with a single dose of JE-CV vaccine and were to receive a booster dose of JE-CV vaccine on Day 0. This group was not randomized. JE vaccine naïve control children were randomized to receive one single dose of JE-CV on Day 0 (Group 2) or a varicella vaccination on Day 0 (Group 3).This was an open, controlled, multicenter, Phase III trial. Participants in Group 1 were previously vaccinated at 12 to 18 months of age with a single dose of JE-CV vaccine and were to receive a booster dose of JE-CV vaccine on Day 0. This group was not randomized. JE vaccine naïve control children were randomized to receive one single dose of JE-CV on Day 0 (Group 2) or a varicella vaccination on Day 0 (Group 3).
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Assessment of the Memory Immune Response, Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With a Single Dose of JE-CV and Long-Term Follow-Up
Actual Study Start Date :
Aug 25, 2010
Actual Primary Completion Date :
Oct 29, 2010
Actual Study Completion Date :
Oct 12, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: JE-CV Vaccine Booster

Participants previously vaccinated with JE-CV vaccine will receive a booster dose of JE-CV vaccine on Day 0.

Biological: JE-CV Vaccine
0.5 mL (single dose), Subcutaneous
Other Names:
  • IMOJEV

    		•
    Experimental: Group 2: JE-CV Vaccine First Dose

    JE-CV vaccine naïve participants will receive a single dose of JE-CV vaccine on Day 0.

    Biological: JE-CV Vaccine
    0.5 mL (single dose), Subcutaneous
    Other Names:
  • IMOJEV

    		•
    Active Comparator: Group 3: Varicella Vaccine

    JE-CV vaccine naïve participants will receive one dose of Varicella vaccine on Day 0.

    Biological: Varicella Vaccine
    0.5 mL (single dose), Subcutaneous
    Other Names:
  • OKAVAX®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV [Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination]

      The presence of JE virus neutralizing antibodies was measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Day 7 and Day 28) was defined as neutralizing antibody titer ≥ 10 (1/dilution).

    2. Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine [Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination]

      The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or participants with pre vaccination titer ≥10 (1/dilution) and a ≥4-fold increase from pre- to post-vaccination.

    3. Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV [Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination]

      The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.

    4. Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV [Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination]

      The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.

    5. Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV [Day 0 (pre-vaccination)]

      The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Flavivirus positive was defined as titers against JE virus ≥10 (1/dilution) or titers against at least 1 dengue serotype ≥10 (1/dilution). Flavivirus negative was defined as titers against JE virus <10 (1/dilution) and titers against the 4 dengue serotypes <10 (1/dilution).

    6. Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV [Day 0 (pre-vaccination) and Days 7 and 28, and Year 1, 2, 3, 4, and 5 post-vaccination]

      The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Days 7 and 28 and Years 1, 2, 3, 4, and 5) was defined as neutralizing antibody titer ≥ 10 (1/dilution).

    7. Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV [Day 0 (pre-vaccination) and Days 7 and 28 and Year 1, 2, 3, 4, and 5 post-vaccination]

      The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.

    8. Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV [Year 1, 2, 3, 4, and 5 post-vaccination]

      The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.

    9. Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine [Day 0 up to Day 14 post-vaccination]

      Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection-site reactions: Pain, Incapacitating, unable to perform usual activities. Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, 39.0°C; Headache, Malaise, and Myalgia, Significant; prevents daily activities.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    36 Months to 42 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    An individual had to fulfill all of the following criteria in order to be eligible for trial enrollment:

    All Participants

    • Aged 36 to 42 months on the day of inclusion

    • Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative

    • Participant and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures

    • In good general health, based on medical history and physical examination

    For JE-CV vaccine primed group only

    • Participant who was vaccinated with JE-CV in JEC02 trial (NCT00735644)
    An individual fulfilling any of the following criteria was excluded from trial enrollment:

    All Participants

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

    • Planned participation in another clinical trial during the Day 0 - Month 6 period and for Group 1 up to 5 years for any flavivirus vaccine trial

    • Receipt of any vaccine* in the 4 weeks preceding the trial vaccination, except for pandemic influenza vaccination, which may be received at least 2 weeks before study vaccines

    • Planned receipt of any vaccine* in the 4 weeks following the trial vaccination, except for pandemic influenza vaccine. In the event of local or national immunization program with a pandemic influenza vaccine, participants who receive a pandemic influenza vaccine at any time during the trial will not be withdrawn from the trial.

    • Planned receipt of any JE vaccine during the course of the trial

    • Administration of any anti-viral within 2 months preceding the trial vaccination and up to 4 weeks following the trial vaccination

    • Receipt of blood or blood-derived products in the past 3 months, which might interfere with 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

    • Seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the parent/legally acceptable representative

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

    • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances

    • Chronic illness or any underlying illness (such as cardiovascular, kidney, liver or hematological disease or development abnormalities) that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

    • Except in case of national immunization days with oral polio vaccine

    For JE-CV primed participants only

    • Receipt of any JE vaccine other than JE-CV during JEC02 trial(NCT00735644) and since the end of JEC02 trial

    For JE-CV naïve participants only

    • Previous vaccination against flavivirus disease including JE

    • History of flavivirus infection either based on clinical suspicion or laboratory proven

    • Previous vaccination against varicella

    • Previous vaccination with JE-CV in JEC02 study

    • History of varicella, confirmed either clinically, serologically, or microbiologically

    • Known systemic hypersensitivity or anaphylactic/anaphylactoid reaction to neomycin.

    • Known history of thrombocytopenia or idiopathic thrombocytopenic purpura

    Temporary Contraindications:

    A prospective participant was not to be included in the study until the following conditions and/or symptoms had resolved:

    1. Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw (for Groups 1 and 2)

    2. Febrile illness (temperature ≥38.0°C [≥100.4°F]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination (for all participants)

    The Investigator was to postpone vaccination until the situation/condition resolved. Vaccination could be postponed within the timeframe for vaccination indicated in the protocol trial flowchart.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Muntinlupa City Philippines 1781

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur SA

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT01190228
    Other Study ID Numbers:
    • JEC15
    • UTN: U1111-1113-3629
    First Posted:
    Aug 27, 2010
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Sanofi Pasteur, a Sanofi Company
    Japanese Encephalitis
    Japanese encephalitis chimeric virus vaccine
    Varicella
    Varicella vaccine
    Additional relevant MeSH terms:
    Chickenpox
    Herpes Zoster
    Encephalitis, Japanese
    Encephalitis
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details Study participants were enrolled from 25 August 2010 to 12 October 2015 at 3 clinic sites in the Philippines.
    Pre-assignment Detail A total of 454 participants who met all inclusion criteria and no exclusion criteria were enrolled in Group 1 or randomized to Group 2 or Group 3 on Day 0. All except 4 participants in Group 1 were vaccinated as planned (345 participants in Group 1, 46 participants in Group 2, and 59 participants in Group 3).
    Arm/Group Title JE-CV Vaccine Booster JE-CV Vaccine First Dose Varicella Vaccine Group
    Arm/Group Description Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial. JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group). JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
    Period Title: Overall Study
    STARTED 349 46 59
    COMPLETED 344 46 59
    NOT COMPLETED 5 0 0

    Baseline Characteristics

    Arm/Group Title JE-CV Vaccine Booster JE-CV Vaccine First Dose Varicella Vaccine Group Total
    Arm/Group Description Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial. JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group). JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group). Total of all reporting groups
    Overall Participants 345 46 59 450
    Age (Count of Participants)
    <=18 years
    345
    100%
    46
    100%
    59
    100%
    450
    100%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Age (Months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Months]
    39.6
    (1.71)
    39.3
    (1.99)
    39.3
    (2.09)
    39.5
    (1.79)
    Sex: Female, Male (Count of Participants)
    Female
    172
    49.9%
    25
    54.3%
    29
    49.2%
    226
    50.2%
    Male
    173
    50.1%
    21
    45.7%
    30
    50.8%
    224
    49.8%
    Region of Enrollment (Number) [Number]
    Philippines
    345
    100%
    46
    100%
    59
    100%
    450
    100%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV
    Description The presence of JE virus neutralizing antibodies was measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Day 7 and Day 28) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
    Time Frame Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Seroprotection against JE-CV vaccine was assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.
    Arm/Group Title JE-CV Booster JE-CV First Dose
    Arm/Group Description Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial. JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
    Measure Participants 340 39
    Day 0 (pre-vaccination)
    80.3
    23.3%
    0
    0%
    Day 7 post-vaccination
    96.2
    27.9%
    15.4
    33.5%
    Day 28 post-vaccination
    100.0
    29%
    89.7
    195%
    2. Primary Outcome
    Title Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine
    Description The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or participants with pre vaccination titer ≥10 (1/dilution) and a ≥4-fold increase from pre- to post-vaccination.
    Time Frame Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Seroconversion was assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.
    Arm/Group Title JE-CV Booster JE-CV First Dose
    Arm/Group Description Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial. JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
    Measure Participants 340 39
    Day 7 post-vaccination
    66.8
    19.4%
    15.4
    33.5%
    Day 28 post-vaccination
    95.3
    27.6%
    89.7
    195%
    3. Primary Outcome
    Title Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
    Description The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
    Time Frame Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.
    Arm/Group Title JE-CV Booster JE-CV First Dose
    Arm/Group Description Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial. JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
    Measure Participants 340 39
    Day 0 (pre-vaccination)
    39.4
    5.00
    Day 7 post-vaccination
    231
    6.41
    Day 28 post-vaccination
    2242
    178
    4. Primary Outcome
    Title Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
    Description The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
    Time Frame Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.
    Arm/Group Title JE-CV Booster JE-CV First Dose
    Arm/Group Description Participants previously received a single dose of JE-CV Vaccine in the JEC02 trial and also received a booster dose of JE-CV in the current trial. JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
    Measure Participants 340 39
    Day 7 post-vaccination
    5.87
    1.28
    Day 28 post-vaccination
    57.0
    35.6
    5. Primary Outcome
    Title Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
    Description The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Flavivirus positive was defined as titers against JE virus ≥10 (1/dilution) or titers against at least 1 dengue serotype ≥10 (1/dilution). Flavivirus negative was defined as titers against JE virus <10 (1/dilution) and titers against the 4 dengue serotypes <10 (1/dilution).
    Time Frame Day 0 (pre-vaccination)

    Outcome Measure Data

    Analysis Population Description
    Serological flavivirus status at baseline was assessed in the Full Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.
    Arm/Group Title JE-CV Booster JE-CV First Dose
    Arm/Group Description Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial. JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group).
    Measure Participants 345 46
    Any JE-CV and/or dengue virus; Flavivirus positive
    289
    83.8%
    14
    30.4%
    Any JE-CV and/or dengue virus; Flavivirus negative
    56
    16.2%
    32
    69.6%
    JE-CV virus strain
    277
    80.3%
    7
    15.2%
    Any dengue serotype
    121
    35.1%
    11
    23.9%
    Dengue serotype 1
    116
    33.6%
    11
    23.9%
    Dengue serotype 2
    102
    29.6%
    11
    23.9%
    Dengue serotype 3
    96
    27.8%
    9
    19.6%
    Dengue serotype 4
    108
    31.3%
    9
    19.6%
    6. Primary Outcome
    Title Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
    Description The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Days 7 and 28 and Years 1, 2, 3, 4, and 5) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
    Time Frame Day 0 (pre-vaccination) and Days 7 and 28, and Year 1, 2, 3, 4, and 5 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Seroprotection was assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.
    Arm/Group Title JE-CV Booster
    Arm/Group Description Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
    Measure Participants 345
    Day 0 (pre-vaccination)
    80.3
    23.3%
    Day 7 post-vaccination
    96.2
    27.9%
    Day 28 post-vaccination
    100.0
    29%
    Year 1 post-vaccination
    99.4
    28.8%
    Year 2 post-vaccination
    98.8
    28.6%
    Year 3 post-vaccination
    99.1
    28.7%
    Year 4 post-vaccination
    98.2
    28.5%
    Year 5 post-vaccination
    98.2
    28.5%
    7. Primary Outcome
    Title Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
    Description The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
    Time Frame Day 0 (pre-vaccination) and Days 7 and 28 and Year 1, 2, 3, 4, and 5 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Geometric mean titers of JE virus antibodies were assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.
    Arm/Group Title JE-CV Booster
    Arm/Group Description Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial.
    Measure Participants 345
    Day 0 (pre-vaccination)
    39.3
    Day 7 post-vaccination
    233
    Day 28 post-vaccination
    2259
    Year 1 post-vaccination
    596
    Year 2 post-vaccination
    368
    Year 3 post-vaccination
    301
    Year 4 post-vaccination
    249
    Year 5 post-vaccination
    161
    8. Primary Outcome
    Title Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
    Description The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
    Time Frame Year 1, 2, 3, 4, and 5 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Geometric mean titer ratios of JE virus antibodies were assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.
    Arm/Group Title JE-CV Booster
    Arm/Group Description Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial
    Measure Participants 345
    Year 2/Year 1
    0.615
    Year 3/Year 2
    0.821
    Year 4/Year 3
    0.827
    Year 5/Year 4
    0.646
    9. Primary Outcome
    Title Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
    Description Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection-site reactions: Pain, Incapacitating, unable to perform usual activities. Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, 39.0°C; Headache, Malaise, and Myalgia, Significant; prevents daily activities.
    Time Frame Day 0 up to Day 14 post-vaccination

    Outcome Measure Data

    Analysis Population Description
    Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
    Arm/Group Title JE-CV Booster JE-CV First Dose Varicella Vaccine Group
    Arm/Group Description Participants previously received a single dose of JE-CV in the JEC02 trial and also received a booster dose of JE-CV in the current trial. JE naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group). JE naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
    Measure Participants 345 46 59
    Injection-site Pain
    73
    21.2%
    13
    28.3%
    12
    20.3%
    Grade 3 Injection-site Pain
    0
    0%
    0
    0%
    0
    0%
    Injection-site Erythema
    29
    8.4%
    1
    2.2%
    4
    6.8%
    Grade 3 Injection-site Erythema
    0
    0%
    0
    0%
    0
    0%
    Injection-site Swelling
    19
    5.5%
    0
    0%
    1
    1.7%
    Grade 3 Injection-site Swelling
    0
    0%
    0
    0%
    0
    0%
    Fever
    49
    14.2%
    1
    2.2%
    9
    15.3%
    Grade 3 Fever
    6
    1.7%
    1
    2.2%
    0
    0%
    Headache
    41
    11.9%
    5
    10.9%
    8
    13.6%
    Grade 3 Headache
    2
    0.6%
    0
    0%
    0
    0%
    Malaise
    49
    14.2%
    6
    13%
    6
    10.2%
    Grade 3 Malaise
    2
    0.6%
    0
    0%
    0
    0%
    Myalgia
    19
    5.5%
    2
    4.3%
    2
    3.4%
    Grade 3 Myalgia
    1
    0.3%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Adverse event data were collected from Day 0 up Day 14 post-vaccination for solicited AEs, up to Day 28 post-vaccination for unsolicited AEs, and up to 5 years post-vaccination for SAEs.
    Adverse Event Reporting Description
    Arm/Group Title JE-CV Vaccine Booster JE-CV Vaccine First Dose Varicella Vaccine Group
    Arm/Group Description Participants previously received a single dose of JE-CV Vaccine in the JEC02 trial and also received a booster dose of JE-CV in the current trial. JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group). JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group).
    All Cause Mortality
    JE-CV Vaccine Booster JE-CV Vaccine First Dose Varicella Vaccine Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/345 (0%) 0/46 (0%) 0/59 (0%)
    Serious Adverse Events
    JE-CV Vaccine Booster JE-CV Vaccine First Dose Varicella Vaccine Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/345 (0.9%) 0/46 (0%) 0/59 (0%)
    Infections and infestations
    Dengue fever 2/345 (0.6%) 2 0/46 (0%) 0 0/59 (0%) 0
    Nervous system disorders
    Febrile convulsion 1/345 (0.3%) 1 0/46 (0%) 0 0/59 (0%) 0
    Other (Not Including Serious) Adverse Events
    JE-CV Vaccine Booster JE-CV Vaccine First Dose Varicella Vaccine Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 73/345 (21.2%) 13/46 (28.3%) 12/59 (20.3%)
    General disorders
    Injection site Pain 73/345 (21.2%) 73 13/46 (28.3%) 13 12/59 (20.3%) 12
    Injection site Erythema 29/345 (8.4%) 29 1/46 (2.2%) 1 4/59 (6.8%) 4
    Injection site Swelling 19/345 (5.5%) 19 0/46 (0%) 0 1/59 (1.7%) 1
    Fever 49/345 (14.2%) 49 1/46 (2.2%) 1 9/59 (15.3%) 9
    Malaise 49/345 (14.2%) 49 6/46 (13%) 6 6/59 (10.2%) 6
    Infections and infestations
    Rhinitis 12/345 (3.5%) 12 1/46 (2.2%) 1 3/59 (5.1%) 3
    Upper respiratory tract infection 37/345 (10.7%) 41 3/46 (6.5%) 4 6/59 (10.2%) 6
    Musculoskeletal and connective tissue disorders
    Myalgia 19/345 (5.5%) 19 2/46 (4.3%) 2 2/59 (3.4%) 2
    Nervous system disorders
    Headache 41/345 (11.9%) 41 5/46 (10.9%) 5 8/59 (13.6%) 8

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications

    Results Point of Contact

    Name/Title Medical Director
    Organization Sanofi Pasteur Inc.
    Phone
    Email RegistryContactUs@sanofipasteur.com
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT01190228
    Other Study ID Numbers:
    • JEC15
    • UTN: U1111-1113-3629
    First Posted:
    Aug 27, 2010
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Mar 1, 2022