Japanese Encephalitis, Hepatitis A
Conditions
Keywords
Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain
Brief summary
This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months. Primary objective: To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur. Secondary objective: To describe the safety of vaccination in all subjects
Detailed description
This is a Phase III trial in toddlers in Thailand and the Philippines.
Interventions
BIOLOGICALJapanese encephalitis vaccine
0.5 mL, Subcutaneous
BIOLOGICALJapanese encephalitis vaccine (Acambis)
0.5 mL, Subcutaneous
BIOLOGICALHepatitis A vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
: * Aged 12 to 18 months on the day of inclusion. * In good general health, without significant medical history. * Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations. * Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures. * Completion of vaccinations according to the national immunization schedule.
Exclusion criteria
: * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination. * Planned participation in another clinical trial during the present trial period. * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. * Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances. * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. * Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response. * Administration of any anti-viral within 2 months preceding V01. * History of central nervous system disorder or disease, including seizures. * Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * Planned receipt of any vaccine in the 4 weeks following any trial vaccination. * Personal human immunodeficiency virus seropositivity in the blood sample taken at screening. * Receipt of any JE vaccine or hepatitis A vaccine. * Previous vaccination against flavivirus disease. * History of flavivirus infection (confirmed either clinically, serologically or microbiologically) * Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination. * Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots | Day 0 (pre-vaccination) and Day 28 post-vaccination | Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 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 4-fold increase from pre- to post-vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV | Day 0 (pre-vaccination) and Day 28 post-vaccination | Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay. |
| Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV | Day 0 (pre-vaccination) and Day 28 post-vaccination | Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil). |
| Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay. |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Day 0 up to Day 14 post-vaccination | Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature \>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 up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Day 0 (pre-vaccination) | Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain \<10 l/dil and anti-dengue against the 4 serotypes \<10 l/dilution. |
Countries
Philippines, Thailand
Participant flow
Recruitment details
The study participants were enrolled from 02 August 2008 through 27 March 2009 at 3 clinic sites in Thailand and 5 clinic sites in the Philippines.
Pre-assignment details
A total of 1200 participants who met all of the inclusion and none of the exclusion criteria were randomized, 1199 were vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| JE CV GPO MBP (Lot 1) Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously | 303 |
| JE-CV GPO MBP (Lot 2) Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 | 299 |
| JE-CV GPO MBP (Lot 3) Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3 | 296 |
| JE-CV WRAIR Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) | 199 |
| Hepatitis A Participants 12 to 18 months of age received Hepatitis A vaccine | 102 |
| Total | 1,199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Did not receive study vaccine | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | JE CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 303 Participants | 299 Participants | 296 Participants | 199 Participants | 102 Participants | 1199 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.3 Months STANDARD_DEVIATION 1.91 | 14.5 Months STANDARD_DEVIATION 1.84 | 14.4 Months STANDARD_DEVIATION 1.88 | 14.3 Months STANDARD_DEVIATION 1.81 | 14.3 Months STANDARD_DEVIATION 1.93 | 14.4 Months STANDARD_DEVIATION 1.87 |
| Region of Enrollment Philippines | 180 Participants | 177 Participants | 175 Participants | 117 Participants | 60 Participants | 709 Participants |
| Region of Enrollment Thailand | 123 Participants | 122 Participants | 121 Participants | 82 Participants | 42 Participants | 490 Participants |
| Sex: Female, Male Female | 155 Participants | 138 Participants | 143 Participants | 94 Participants | 45 Participants | 575 Participants |
| Sex: Female, Male Male | 148 Participants | 161 Participants | 153 Participants | 105 Participants | 57 Participants | 624 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 91 / 302 | 99 / 299 | 87 / 297 | 65 / 199 | 36 / 102 |
| serious Total, serious adverse events | 10 / 302 | 17 / 299 | 13 / 297 | 7 / 199 | 7 / 102 |
Outcome results
Primary
Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots
Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 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 4-fold increase from pre- to post-vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Seroconversion to the JE CV vaccine antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE CV GPO MBP (Lot 1) | Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots | JE CV Day 0 (≥10 1/dil; N=288, 290, 285, 192, 0) | 0 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots | JE CV Day 28 (≥10 1/dil; N=288, 284, 283, 192, 0) | 282 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots | JE CV Day 0 (≥10 1/dil; N=288, 290, 285, 192, 0) | 0 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots | JE CV Day 28 (≥10 1/dil; N=288, 284, 283, 192, 0) | 262 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots | JE CV Day 0 (≥10 1/dil; N=288, 290, 285, 192, 0) | 0 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots | JE CV Day 28 (≥10 1/dil; N=288, 284, 283, 192, 0) | 267 Participants |
| JE-CV WRAIR | Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots | JE CV Day 28 (≥10 1/dil; N=288, 284, 283, 192, 0) | 185 Participants |
| JE-CV WRAIR | Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots | JE CV Day 0 (≥10 1/dil; N=288, 290, 285, 192, 0) | 0 Participants |
| Hepatitis A | Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots | JE CV Day 0 (≥10 1/dil; N=288, 290, 285, 192, 0) | NA Participants |
| Hepatitis A | Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots | JE CV Day 28 (≥10 1/dil; N=288, 284, 283, 192, 0) | NA Participants |
Secondary
Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV
Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean titers against the JE CV antigens were assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| JE CV GPO MBP (Lot 1) | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV | Anti JE-CV Day 0 (N=288, 290, 285, 192, 0) | 5.17 Titers |
| JE CV GPO MBP (Lot 1) | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV | Anti JE CV Day 28 (N=288, 284, 283, 192, 0) | 212 Titers |
| JE-CV GPO MBP (Lot 2) | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV | Anti JE CV Day 28 (N=288, 284, 283, 192, 0) | 167 Titers |
| JE-CV GPO MBP (Lot 2) | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV | Anti JE-CV Day 0 (N=288, 290, 285, 192, 0) | 5.08 Titers |
| JE-CV GPO MBP (Lot 3) | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV | Anti JE-CV Day 0 (N=288, 290, 285, 192, 0) | 5.19 Titers |
| JE-CV GPO MBP (Lot 3) | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV | Anti JE CV Day 28 (N=288, 284, 283, 192, 0) | 188 Titers |
| JE-CV WRAIR | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV | Anti JE-CV Day 0 (N=288, 290, 285, 192, 0) | 5.09 Titers |
| JE-CV WRAIR | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV | Anti JE CV Day 28 (N=288, 284, 283, 192, 0) | 212 Titers |
Secondary
Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine
Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean titers against the JE CV antigens were assessed in the Per Protocol Analysis Set.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| JE CV GPO MBP (Lot 1) | Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine | 41.1 Titer ratio |
| JE-CV GPO MBP (Lot 2) | Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine | 32.9 Titer ratio |
| JE-CV GPO MBP (Lot 3) | Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine | 36.6 Titer ratio |
| JE-CV WRAIR | Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine | 42.2 Titer ratio |
| Hepatitis A | Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine | NA Titer ratio |
Secondary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.
Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature \>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 up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.
Time frame: Day 0 up to Day 14 post-vaccination
Population: Solicited injection site and systemic reactions were assessed in the Safety Analysis Set. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Erythema | 0 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Crying Abnormal | 58 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Tenderness | 0 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Appetite Lost | 82 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Irritability | 2 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Swelling | 22 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Crying Abnormal | 1 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Tenderness | 58 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Drowsiness | 0 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Irritability | 91 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Swelling | 0 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Vomiting | 3 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Erythema | 64 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Drowsiness | 58 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Fever | 3 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Fever | 51 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Appetite Lost | 3 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Vomiting | 60 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Vomiting | 1 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Fever | 5 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Vomiting | 57 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Irritability | 79 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Tenderness | 0 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Appetite Lost | 1 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Erythema | 63 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Appetite Lost | 71 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Erythema | 0 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Irritability | 0 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Drowsiness | 0 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Swelling | 20 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Drowsiness | 53 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Swelling | 0 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Tenderness | 59 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Crying Abnormal | 0 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Fever | 62 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Crying Abnormal | 54 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Erythema | 87 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Tenderness | 67 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Tenderness | 0 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Erythema | 0 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Swelling | 21 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Swelling | 0 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Fever | 64 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Fever | 3 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Vomiting | 53 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Vomiting | 1 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Crying Abnormal | 50 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Crying Abnormal | 1 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Drowsiness | 53 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Drowsiness | 0 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Appetite Lost | 74 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Appetite Lost | 1 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Irritability | 79 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Irritability | 1 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Irritability | 1 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Crying Abnormal | 41 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Irritability | 65 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Crying Abnormal | 0 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Swelling | 0 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Drowsiness | 38 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Swelling | 13 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Tenderness | 59 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Drowsiness | 0 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Erythema | 0 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Appetite Lost | 57 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Erythema | 54 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Appetite Lost | 2 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Tenderness | 0 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Vomiting | 39 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Fever | 1 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Vomiting | 1 Participants |
| JE-CV WRAIR | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Fever | 48 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Erythema | 26 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Fever | 21 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Crying Abnormal | 21 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Swelling | 0 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Appetite Lost | 27 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Vomiting | 16 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Crying Abnormal | 0 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Tenderness | 0 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Swelling | 4 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Irritability | 28 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Irritability | 1 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Drowsiness | 20 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Vomiting | 1 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Injection site Erythema | 0 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Appetite Lost | 0 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Fever | 0 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Grade 3 Drowsiness | 0 Participants |
| Hepatitis A | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. | Injection site Tenderness | 18 Participants |
Secondary
Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV
Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Seroprotection against JE CV antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE CV GPO MBP (Lot 1) | Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV | JE CV Day 0 (N=288, 290, 285, 192, 0) | 10 Participants |
| JE CV GPO MBP (Lot 1) | Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV | JE CV Day 28 (N=288, 284, 283, 192, 0) | 297 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV | JE CV Day 0 (N=288, 290, 285, 192, 0) | 4 Participants |
| JE-CV GPO MBP (Lot 2) | Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV | JE CV Day 28 (N=288, 284, 283, 192, 0) | 269 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV | JE CV Day 0 (N=288, 290, 285, 192, 0) | 8 Participants |
| JE-CV GPO MBP (Lot 3) | Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV | JE CV Day 28 (N=288, 284, 283, 192, 0) | 276 Participants |
| JE-CV WRAIR | Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV | JE CV Day 28 (N=288, 284, 283, 192, 0) | 190 Participants |
| JE-CV WRAIR | Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV | JE CV Day 0 (N=288, 290, 285, 192, 0) | 2 Participants |
| Hepatitis A | Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV | JE CV Day 0 (N=288, 290, 285, 192, 0) | NA Participants |
| Hepatitis A | Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV | JE CV Day 28 (N=288, 284, 283, 192, 0) | NA Participants |
Other Pre-specified
Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.
Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain \<10 l/dil and anti-dengue against the 4 serotypes \<10 l/dilution.
Time frame: Day 0 (pre-vaccination)
Population: Serological status of Flavivirus infection was assessed in the Per-protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE CV GPO MBP (Lot 1) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 2 (N=284, 289, 282, 192, 97) | 15 Participants |
| JE CV GPO MBP (Lot 1) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV/dengue FV positive (N=288,290,285,192,97) | 19 Participants |
| JE CV GPO MBP (Lot 1) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV/dengue FV negative (N=288,290,285,192,97) | 265 Participants |
| JE CV GPO MBP (Lot 1) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV (N=288, 290, 285, 192, 97) | 0 Participants |
| JE CV GPO MBP (Lot 1) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 1 (N=284, 289, 282, 192, 97) | 17 Participants |
| JE CV GPO MBP (Lot 1) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 3 (N=284, 289, 282, 192, 97) | 16 Participants |
| JE CV GPO MBP (Lot 1) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 4 (N=284, 289, 282, 192, 97) | 10 Participants |
| JE-CV GPO MBP (Lot 2) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 4 (N=284, 289, 282, 192, 97) | 6 Participants |
| JE-CV GPO MBP (Lot 2) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV/dengue FV negative (N=288,290,285,192,97) | 266 Participants |
| JE-CV GPO MBP (Lot 2) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV/dengue FV positive (N=288,290,285,192,97) | 23 Participants |
| JE-CV GPO MBP (Lot 2) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 2 (N=284, 289, 282, 192, 97) | 18 Participants |
| JE-CV GPO MBP (Lot 2) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 1 (N=284, 289, 282, 192, 97) | 19 Participants |
| JE-CV GPO MBP (Lot 2) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 3 (N=284, 289, 282, 192, 97) | 18 Participants |
| JE-CV GPO MBP (Lot 2) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV (N=288, 290, 285, 192, 97) | 0 Participants |
| JE-CV GPO MBP (Lot 3) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 3 (N=284, 289, 282, 192, 97) | 27 Participants |
| JE-CV GPO MBP (Lot 3) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV/dengue FV positive (N=288,290,285,192,97) | 32 Participants |
| JE-CV GPO MBP (Lot 3) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV (N=288, 290, 285, 192, 97) | 0 Participants |
| JE-CV GPO MBP (Lot 3) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV/dengue FV negative (N=288,290,285,192,97) | 249 Participants |
| JE-CV GPO MBP (Lot 3) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 4 (N=284, 289, 282, 192, 97) | 13 Participants |
| JE-CV GPO MBP (Lot 3) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 1 (N=284, 289, 282, 192, 97) | 28 Participants |
| JE-CV GPO MBP (Lot 3) | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 2 (N=284, 289, 282, 192, 97) | 26 Participants |
| JE-CV WRAIR | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV/dengue FV negative (N=288,290,285,192,97) | 176 Participants |
| JE-CV WRAIR | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 3 (N=284, 289, 282, 192, 97) | 12 Participants |
| JE-CV WRAIR | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 2 (N=284, 289, 282, 192, 97) | 11 Participants |
| JE-CV WRAIR | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV (N=288, 290, 285, 192, 97) | 0 Participants |
| JE-CV WRAIR | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 4 (N=284, 289, 282, 192, 97) | 7 Participants |
| JE-CV WRAIR | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV/dengue FV positive (N=288,290,285,192,97) | 15 Participants |
| JE-CV WRAIR | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 1 (N=284, 289, 282, 192, 97) | 14 Participants |
| Hepatitis A | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV/dengue FV positive (N=288,290,285,192,97) | 13 Participants |
| Hepatitis A | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV/dengue FV negative (N=288,290,285,192,97) | 84 Participants |
| Hepatitis A | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | JE CV (N=288, 290, 285, 192, 97) | 0 Participants |
| Hepatitis A | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 1 (N=284, 289, 282, 192, 97) | 13 Participants |
| Hepatitis A | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 2 (N=284, 289, 282, 192, 97) | 12 Participants |
| Hepatitis A | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 3 (N=284, 289, 282, 192, 97) | 11 Participants |
| Hepatitis A | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. | Dengue serotype 4 (N=284, 289, 282, 192, 97) | 8 Participants |