Japanese Encephalitis, Varicella
Conditions
Keywords
Japanese Encephalitis, Japanese encephalitis chimeric virus vaccine, Varicella, Varicella vaccine
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.
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.
Interventions
BIOLOGICALJE-CV Vaccine
0.5 mL (single dose), Subcutaneous
BIOLOGICALVaricella Vaccine
0.5 mL (single dose), Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
36 Months to 42 Months
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
| 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). |
| 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). |
| 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. |
| 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. |
| 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. |
Countries
Philippines
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 details
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).
Participants by arm
| Arm | Count |
|---|---|
| JE-CV Vaccine Booster 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. | 345 |
| JE-CV Vaccine First Dose JE vaccine naïve control participants received a single dose of JE-CV on Day 0 (Immunogenicity Control group). | 46 |
| Varicella Vaccine Group JE vaccine naïve control participants received a varicella vaccination (Okavax®) on Day 0 (Safety Control group). | 59 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 4 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | JE-CV Vaccine First Dose | Varicella Vaccine Group | JE-CV Vaccine Booster | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 46 Participants | 59 Participants | 345 Participants | 450 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 39.3 Months STANDARD_DEVIATION 1.99 | 39.3 Months STANDARD_DEVIATION 2.09 | 39.6 Months STANDARD_DEVIATION 1.71 | 39.5 Months STANDARD_DEVIATION 1.79 |
| Region of Enrollment Philippines | 46 Participants | 59 Participants | 345 Participants | 450 Participants |
| Sex: Female, Male Female | 25 Participants | 29 Participants | 172 Participants | 226 Participants |
| Sex: Female, Male Male | 21 Participants | 30 Participants | 173 Participants | 224 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 345 | 0 / 46 | 0 / 59 |
| other Total, other adverse events | 73 / 345 | 13 / 46 | 12 / 59 |
| serious Total, serious adverse events | 3 / 345 | 0 / 46 | 0 / 59 |
Outcome results
Primary
Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine
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
Population: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Injection-site Pain | 73 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Injection-site Pain | 0 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Injection-site Erythema | 29 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Injection-site Erythema | 0 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Injection-site Swelling | 0 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Fever | 49 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Fever | 6 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Headache | 41 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Headache | 2 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Malaise | 49 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Malaise | 2 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Myalgia | 19 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Myalgia | 1 Participants |
| JE-CV Booster | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Injection-site Swelling | 19 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Malaise | 0 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Fever | 1 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Fever | 1 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Myalgia | 2 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Headache | 5 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Headache | 0 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Injection-site Pain | 0 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Injection-site Pain | 13 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Malaise | 6 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Injection-site Erythema | 1 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Myalgia | 0 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Injection-site Erythema | 0 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Injection-site Swelling | 0 Participants |
| JE-CV First Dose | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Injection-site Swelling | 0 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Injection-site Swelling | 1 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Injection-site Swelling | 0 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Malaise | 0 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Injection-site Erythema | 4 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Fever | 9 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Myalgia | 0 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Injection-site Pain | 12 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Fever | 0 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Injection-site Erythema | 0 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Injection-site Pain | 0 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Headache | 8 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Myalgia | 2 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Malaise | 6 Participants |
| Varicella Vaccine Group | Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine | Grade 3 Headache | 0 Participants |
Primary
Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV Booster | Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine | Day 7 post-vaccination | 66.8 Percentage of participants |
| JE-CV Booster | Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine | Day 28 post-vaccination | 95.3 Percentage of participants |
| JE-CV First Dose | Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine | Day 7 post-vaccination | 15.4 Percentage of participants |
| JE-CV First Dose | Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine | Day 28 post-vaccination | 89.7 Percentage of participants |
Primary
Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV Booster | Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV | Day 0 (pre-vaccination) | 80.3 Percentage of participants |
| JE-CV Booster | Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV | Day 7 post-vaccination | 96.2 Percentage of participants |
| JE-CV Booster | Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV | Day 28 post-vaccination | 100.0 Percentage of participants |
| JE-CV First Dose | Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV | Day 0 (pre-vaccination) | 0 Percentage of participants |
| JE-CV First Dose | Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV | Day 7 post-vaccination | 15.4 Percentage of participants |
| JE-CV First Dose | Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV | Day 28 post-vaccination | 89.7 Percentage of participants |
Primary
Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV Booster | 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) | 80.3 Percentage of participants |
| JE-CV Booster | Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Day 7 post-vaccination | 96.2 Percentage of participants |
| JE-CV Booster | Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Day 28 post-vaccination | 100.0 Percentage of participants |
| JE-CV Booster | Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 1 post-vaccination | 99.4 Percentage of participants |
| JE-CV Booster | Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 2 post-vaccination | 98.8 Percentage of participants |
| JE-CV Booster | Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 3 post-vaccination | 99.1 Percentage of participants |
| JE-CV Booster | Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 4 post-vaccination | 98.2 Percentage of participants |
| JE-CV Booster | Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 5 post-vaccination | 98.2 Percentage of participants |
Primary
Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| JE-CV Booster | 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) | 39.3 Titers (1/dilution) |
| JE-CV Booster | 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 7 post-vaccination | 233 Titers (1/dilution) |
| JE-CV Booster | 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 28 post-vaccination | 2259 Titers (1/dilution) |
| JE-CV Booster | Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 1 post-vaccination | 596 Titers (1/dilution) |
| JE-CV Booster | Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 2 post-vaccination | 368 Titers (1/dilution) |
| JE-CV Booster | Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 3 post-vaccination | 301 Titers (1/dilution) |
| JE-CV Booster | Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 4 post-vaccination | 249 Titers (1/dilution) |
| JE-CV Booster | Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 5 post-vaccination | 161 Titers (1/dilution) |
Primary
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| JE-CV Booster | Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV | Day 7 post-vaccination | 5.87 Titer ratios (1/dilution) |
| JE-CV Booster | Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV | Day 28 post-vaccination | 57.0 Titer ratios (1/dilution) |
| JE-CV First Dose | Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV | Day 7 post-vaccination | 1.28 Titer ratios (1/dilution) |
| JE-CV First Dose | Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV | Day 28 post-vaccination | 35.6 Titer ratios (1/dilution) |
Primary
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Time frame: Year 1, 2, 3, 4, and 5 post-vaccination
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| JE-CV Booster | Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 2/Year 1 | 0.615 Titer ratios (1/dilution) |
| JE-CV Booster | Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 3/Year 2 | 0.821 Titer ratios (1/dilution) |
| JE-CV Booster | Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 4/Year 3 | 0.827 Titer ratios (1/dilution) |
| JE-CV Booster | Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV | Year 5/Year 4 | 0.646 Titer ratios (1/dilution) |
Primary
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| JE-CV Booster | Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV | Day 0 (pre-vaccination) | 39.4 Titers (1/dilution) |
| JE-CV Booster | Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV | Day 7 post-vaccination | 231 Titers (1/dilution) |
| JE-CV Booster | Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV | Day 28 post-vaccination | 2242 Titers (1/dilution) |
| JE-CV First Dose | Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV | Day 0 (pre-vaccination) | 5.00 Titers (1/dilution) |
| JE-CV First Dose | Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV | Day 7 post-vaccination | 6.41 Titers (1/dilution) |
| JE-CV First Dose | Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV | Day 28 post-vaccination | 178 Titers (1/dilution) |
Primary
Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV
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)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV Booster | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Dengue serotype 1 | 116 Number of participants |
| JE-CV Booster | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Any JE-CV and/or dengue virus; Flavivirus positive | 289 Number of participants |
| JE-CV Booster | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Dengue serotype 3 | 96 Number of participants |
| JE-CV Booster | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Any JE-CV and/or dengue virus; Flavivirus negative | 56 Number of participants |
| JE-CV Booster | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Dengue serotype 2 | 102 Number of participants |
| JE-CV Booster | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | JE-CV virus strain | 277 Number of participants |
| JE-CV Booster | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Dengue serotype 4 | 108 Number of participants |
| JE-CV Booster | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Any dengue serotype | 121 Number of participants |
| JE-CV First Dose | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Dengue serotype 4 | 9 Number of participants |
| JE-CV First Dose | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Dengue serotype 1 | 11 Number of participants |
| JE-CV First Dose | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Dengue serotype 2 | 11 Number of participants |
| JE-CV First Dose | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Dengue serotype 3 | 9 Number of participants |
| JE-CV First Dose | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Any dengue serotype | 11 Number of participants |
| JE-CV First Dose | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Any JE-CV and/or dengue virus; Flavivirus positive | 14 Number of participants |
| JE-CV First Dose | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | Any JE-CV and/or dengue virus; Flavivirus negative | 32 Number of participants |
| JE-CV First Dose | Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV | JE-CV virus strain | 7 Number of participants |