Hepatitis A, Japanese Encephalitis
Conditions
Keywords
Japanese encephalitis (JE), Hepatitis A, Inactivated Mouse-Brain
Brief summary
Safety: To describe the safety profiles following vaccination. Immunogenicity: To describe the immune response after a single dose of vaccine.
Detailed description
This is a randomized, cross-over, open, active controlled, multi-center trial in toddlers and children in Thailand. Stepwise enrollment of children in 2 age cohorts. Subjects will be followed for 5 years.
Interventions
BIOLOGICALJapanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)
BIOLOGICALHepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness. * Completion of vaccinations according to the national immunization schedule * Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures. * Previous receipt of two doses of a mouse-brain-derived JE vaccine at 12 to 15 months of age according to the national immunization schedule and aged 2 to 5 years on the day of inclusion. * Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.
Exclusion criteria
* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. * 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 the trial vaccine or 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. * Receipt of hepatitis A vaccine. * History of flavivirus infection (confirmed either clinically, serologically or microbiologically). * Administration of any anti-viral within 2 months preceding the screening visit. * History of central nervous system disorder or disease. * Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. * Planned participation in another clinical trial during the present trial period. * 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, hepatitis B or hepatitis C seropositivity in the blood sample taken at screening. * Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination. * Previous vaccination against flavivirus disease at any time before the trial other than a mouse-brain-derived JE vaccine given in a two-dose regimen at 12 to 15 months of age in accordance with the national immunization schedule. * Febrile illness or any acute illness/infection on the day of vaccination, according to investigator judgment * History of seizures. * Previous vaccination against flavivirus disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Day 0 up to Day 14 post-vaccination | 12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities. |
| Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Day 0 up to Day 14 post-vaccination | 12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Day 0 (pre-vaccination) and Day 28 after final vaccination | JE virus neutralizing antibody measurement was assessed by 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. |
| Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Day 0 (pre-vaccination) and Day 28 after final vaccination | JE virus neutralizing antibody measurement was assessed by the PRNT50 assay. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Day 0 (pre-vaccination) up to 5 years after final vaccination | Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay. |
| Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Day 0 (pre-vaccination) up to 5 years after final vaccination | Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay. |
Countries
Thailand
Participant flow
Recruitment details
The study participants were enrolled from 02 March 2008 to 06 January 2009 at 3 clinic centers in Thailand.
Pre-assignment details
A total of 300 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| JE CV/Hepatitis A (Group 1) Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | 50 |
| Hepatitis A/JE CV (Group 2) Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart | 50 |
| JE CV/Hepatitis A (Group 3) Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | 101 |
| Hepatitis A/JE CV (Group 4) Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart | 99 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Hepatitis A/JE CV (Group 2) | JE CV/Hepatitis A (Group 3) | JE CV/Hepatitis A (Group 1) | Hepatitis A/JE CV (Group 4) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 101 Participants | 50 Participants | 99 Participants | 300 Participants |
| Age, Categorical >=65 years | 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 |
| Age, Continuous | 2.5 Years STANDARD_DEVIATION 0.6 | 1.4 Years STANDARD_DEVIATION 0.2 | 2.4 Years STANDARD_DEVIATION 0.5 | 1.3 Years STANDARD_DEVIATION 0.2 | 1.7 Years STANDARD_DEVIATION 0.6 |
| Region of Enrollment Thailand | 50 Participants | 101 Participants | 50 Participants | 99 Participants | 300 Participants |
| Sex: Female, Male Female | 35 Participants | 57 Participants | 17 Participants | 57 Participants | 166 Participants |
| Sex: Female, Male Male | 15 Participants | 44 Participants | 33 Participants | 42 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 50 | 18 / 50 | 43 / 101 | 35 / 99 |
| serious Total, serious adverse events | 3 / 50 | 3 / 50 | 11 / 101 | 10 / 99 |
Outcome results
Primary
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities.
Time frame: Day 0 up to Day 14 post-vaccination
Population: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Vomiting (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Crying abnormal (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Irritability (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Crying abnormal (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Tenderness (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Drowsiness (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Irritability (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Drowsiness (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Erythema (N=50,50,101,99) | 0 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Appetite lost (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Tenderness (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Swelling (N=50,50,101,99) | 4 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Malaise (N=50,50,0,0) | 0 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Swelling (N=50,50,101,99) | 0 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Pain (N=50,50,0,0) | 15 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Headache (N=50,50,0,0) | 7 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Malaise (N=50,50,0,0) | 15 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Headache (N=50,50,0,0) | 0 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Erythema (N=50,50,101,99) | 7 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Myalgia (N=50,50,0,0) | 14 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Appetite lost (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Fever (N=50,50,101,99) | 1 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Myalgia (N=50,50,0,0) | 0 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Pain (N=50,50,0,0) | 0 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Vomiting (N=0,0,101,99) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Fever (N=50,50,101,99) | 8 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Erythema (N=50,50,101,99) | 9 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Vomiting (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Appetite lost (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Irritability (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Pain (N=50,50,0,0) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Crying abnormal (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Appetite lost (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Fever (N=50,50,101,99) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Swelling (N=50,50,101,99) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Crying abnormal (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Myalgia (N=50,50,0,0) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Irritability (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Malaise (N=50,50,0,0) | 13 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Drowsiness (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Tenderness (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Myalgia (N=50,50,0,0) | 8 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Headache (N=50,50,0,0) | 7 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Drowsiness (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Pain (N=50,50,0,0) | 13 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Vomiting (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Fever (N=50,50,101,99) | 8 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Tenderness (N=0,0,101,99) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Erythema (N=50,50,101,99) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Malaise (N=50,50,0,0) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Headache (N=50,50,0,0) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Swelling (N=50,50,101,99) | 5 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Malaise (N=50,50,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Erythema (N=50,50,101,99) | 23 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Erythema (N=50,50,101,99) | 0 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Pain (N=50,50,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Pain (N=50,50,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Tenderness (N=0,0,101,99) | 43 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Tenderness (N=0,0,101,99) | 0 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Swelling (N=50,50,101,99) | 6 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Swelling (N=50,50,101,99) | 0 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Headache (N=50,50,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Headache (N=50,50,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Myalgia (N=50,50,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Myalgia (N=50,50,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Vomiting (N=0,0,101,99) | 21 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Vomiting (N=0,0,101,99) | 1 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Crying abnormal (N=0,0,101,99) | 24 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Crying abnormal (N=0,0,101,99) | 0 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Drowsiness (N=0,0,101,99) | 22 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Drowsiness (N=0,0,101,99) | 0 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Irritability (N=0,0,101,99) | 32 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Irritability (N=0,0,101,99) | 0 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Fever (N=50,50,101,99) | 14 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Fever (N=50,50,101,99) | 0 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Malaise (N=50,50,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Appetite lost (N=0,0,101,99) | 28 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Appetite lost (N=0,0,101,99) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Irritability (N=0,0,101,99) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Swelling (N=50,50,101,99) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Vomiting (N=0,0,101,99) | 21 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Myalgia (N=50,50,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Appetite lost (N=0,0,101,99) | 32 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Fever (N=50,50,101,99) | 18 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Myalgia (N=50,50,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Malaise (N=50,50,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Pain (N=50,50,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Headache (N=50,50,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Headache (N=50,50,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Fever (N=50,50,101,99) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Tenderness (N=0,0,101,99) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Malaise (N=50,50,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Swelling (N=50,50,101,99) | 8 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Erythema (N=50,50,101,99) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Erythema (N=50,50,101,99) | 16 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Drowsiness (N=0,0,101,99) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Injection site Tenderness (N=0,0,101,99) | 19 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Appetite lost (N=0,0,101,99) | 2 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Drowsiness (N=0,0,101,99) | 13 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Crying abnormal (N=0,0,101,99) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Injection site Pain (N=50,50,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Irritability (N=0,0,101,99) | 24 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Crying abnormal (N=0,0,101,99) | 20 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection | Grade 3 Vomiting (N=0,0,101,99) | 0 Participants |
Primary
Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities.
Time frame: Day 0 up to Day 14 post-vaccination
Population: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine. A participant in Group 1 was given JE-CV vaccine as the second vaccination in error; and counted for Group 2 for the safety outcome for the second injection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Headache (N=48,51,0,0) | 0 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Fever (N=48,51,100,98) | 5 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Headache (N=48,51,0,0) | 7 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Malaise (N=48,51,0,0) | 0 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Erythema (N=48,51,100,98) | 0 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Appetite lost (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Crying abnormal (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Vomiting (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Pain (N=48,51,0,0) | 0 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Swelling (N=48,51,100,98) | 8 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Irritability (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Vomiting (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Tenderness (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Appetite lost (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Myalgia (N=48,51,0,0) | 0 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Drowsiness (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Fever (N=48,51,100,98) | 1 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Tenderness (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Pain (N=48,51,0,0) | 15 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Drowsiness (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Erythema (N=48,51,100,98) | 8 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Crying abnormal (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Myalgia (N=48,51,0,0) | 7 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Irritability (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Malaise (N=48,51,0,0) | 13 Participants |
| JE-CV/Hepatitis A (Group 1) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Swelling (N=48,51,100,98) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Malaise (N=48,51,0,0) | 18 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Irritability (N=0,0,100,98) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Swelling (N=48,51,100,98) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Pain (N=48,51,0,0) | 9 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Appetite lost (N=0,0,100,98) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Pain (N=48,51,0,0) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Headache (N=48,51,0,0) | 14 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Erythema (N=48,51,100,98) | 7 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Erythema (N=48,51,100,98) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Fever (N=48,51,100,98) | 14 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Crying abnormal (N=0,0,100,98) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Fever (N=48,51,100,98) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Tenderness (N=0,0,100,98) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Headache (N=48,51,0,0) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Tenderness (N=0,0,100,98) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Crying abnormal (N=0,0,100,98) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Malaise (N=48,51,0,0) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Vomiting (N=0,0,100,98) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Myalgia (N=48,51,0,0) | 0 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Vomiting (N=0,0,100,98) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Swelling (N=48,51,100,98) | 4 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Drowsiness (N=0,0,100,98) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Myalgia (N=48,51,0,0) | 10 Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Drowsiness (N=0,0,100,98) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Appetite lost (N=0,0,100,98) | NA Participants |
| Hepatitis A/JE-CV (Group 2) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Irritability (N=0,0,100,98) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Crying abnormal (N=0,0,100,98) | 19 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Tenderness (N=0,0,100,98) | 35 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Tenderness (N=0,0,100,98) | 1 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Swelling (N=48,51,100,98) | 6 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Swelling (N=48,51,100,98) | 0 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Fever (N=48,51,100,98) | 23 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Fever (N=48,51,100,98) | 1 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Malaise (N=48,51,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Malaise (N=48,51,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Vomiting (N=0,0,100,98) | 23 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Vomiting (N=0,0,100,98) | 1 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Drowsiness (N=0,0,100,98) | 17 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Drowsiness (N=0,0,100,98) | 0 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Irritability (N=0,0,100,98) | 22 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Irritability (N=0,0,100,98) | 1 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Pain (N=48,51,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Pain (N=48,51,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Erythema (N=48,51,100,98) | 23 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Erythema (N=48,51,100,98) | 0 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Headache (N=48,51,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Headache (N=48,51,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Myalgia (N=48,51,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Myalgia (N=48,51,0,0) | NA Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Crying abnormal (N=0,0,100,98) | 2 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Appetite lost (N=0,0,100,98) | 26 Participants |
| JE-CV/Hepatitis A (Group 3) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Appetite lost (N=0,0,100,98) | 2 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Irritability (N=0,0,100,98) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Malaise (N=48,51,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Appetite lost (N=0,0,100,98) | 1 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Drowsiness (N=0,0,100,98) | 14 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Appetite lost (N=0,0,100,98) | 24 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Myalgia (N=48,51,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Crying abnormal (N=0,0,100,98) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Vomiting (N=0,0,100,98) | 19 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Erythema (N=48,51,100,98) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Vomiting (N=0,0,100,98) | 1 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Myalgia (N=48,51,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Malaise (N=48,51,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Pain (N=48,51,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Crying abnormal (N=0,0,100,98) | 21 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Headache (N=48,51,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Fever (N=48,51,100,98) | 28 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Tenderness (N=0,0,100,98) | 20 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Drowsiness (N=0,0,100,98) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Swelling (N=48,51,100,98) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Fever (N=48,51,100,98) | 2 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Erythema (N=48,51,100,98) | 22 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Grade 3 Injection site Tenderness (N=0,0,100,98) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Swelling (N=48,51,100,98) | 11 Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Headache (N=48,51,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Injection site Pain (N=48,51,0,0) | NA Participants |
| Hepatitis A/JE-CV (Group 4) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection | Irritability (N=0,0,100,98) | 24 Participants |
Secondary
Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination
JE virus neutralizing antibody measurement was assessed by 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 after final vaccination
Population: Seroconversion to the JE-CV vaccine antigens was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV/Hepatitis A (Group 1) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Homologous virus (N=49,48,83,88) | 89.8 Percentage of participants |
| JE-CV/Hepatitis A (Group 1) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype III (N=49,48,81,93) | 87.8 Percentage of participants |
| JE-CV/Hepatitis A (Group 1) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype I (N=49,48,81,91) | 83.7 Percentage of participants |
| JE-CV/Hepatitis A (Group 1) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype IV (N=49,48,81,90) | 89.8 Percentage of participants |
| JE-CV/Hepatitis A (Group 1) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype II (N=49,48,81,91) | 83.7 Percentage of participants |
| Hepatitis A/JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Homologous virus (N=49,48,83,88) | 95.8 Percentage of participants |
| Hepatitis A/JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype IV (N=49,48,81,90) | 91.7 Percentage of participants |
| Hepatitis A/JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype I (N=49,48,81,91) | 93.8 Percentage of participants |
| Hepatitis A/JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype III (N=49,48,81,93) | 91.7 Percentage of participants |
| Hepatitis A/JE-CV (Group 2) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype II (N=49,48,81,91) | 93.8 Percentage of participants |
| JE-CV/Hepatitis A (Group 3) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype II (N=49,48,81,91) | 96.3 Percentage of participants |
| JE-CV/Hepatitis A (Group 3) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype III (N=49,48,81,93) | 100.0 Percentage of participants |
| JE-CV/Hepatitis A (Group 3) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype IV (N=49,48,81,90) | 74.1 Percentage of participants |
| JE-CV/Hepatitis A (Group 3) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Homologous virus (N=49,48,83,88) | 100.0 Percentage of participants |
| JE-CV/Hepatitis A (Group 3) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype I (N=49,48,81,91) | 98.8 Percentage of participants |
| Hepatitis A/JE-CV (Group 4) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype II (N=49,48,81,91) | 95.6 Percentage of participants |
| Hepatitis A/JE-CV (Group 4) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype I (N=49,48,81,91) | 95.6 Percentage of participants |
| Hepatitis A/JE-CV (Group 4) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype IV (N=49,48,81,90) | 65.6 Percentage of participants |
| Hepatitis A/JE-CV (Group 4) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Genotype III (N=49,48,81,93) | 94.6 Percentage of participants |
| Hepatitis A/JE-CV (Group 4) | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination | Homologous virus (N=49,48,83,88) | 93.2 Percentage of participants |
Secondary
Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination
JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
Population: Geometric mean titers against the JE-CV vaccine antigens were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype III (post-vaccination; N=49,48,82,94) | 1107 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype I (post-vaccination; N=49,48,82,94) | 1016 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype I (pre-vaccination; N=49,48,83,91) | 55.2 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype IV (post-vaccination; N=49,48,82,94) | 604 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Homologous virus (post-vaccination; N=49,48,84,93) | 1957 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Homologous virus (pre-vaccination; N=49,48,86,90) | 49.5 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype III (pre-vaccination; N=49,48,83,93) | 39.2 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype II (post-vaccination; N=49,48,82,94) | 921 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype II (pre-vaccination; N=49,48,83,91) | 46.5 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype IV (pre-vaccination; N=49,48,83,90) | 25.2 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype III (post-vaccination; N=49,48,82,94) | 2089 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Homologous virus (pre-vaccination; N=49,48,86,90) | 40.6 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Homologous virus (post-vaccination; N=49,48,84,93) | 3568 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype IV (pre-vaccination; N=49,48,83,90) | 20.0 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype IV (post-vaccination; N=49,48,82,94) | 829 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype I (pre-vaccination; N=49,48,83,91) | 55.3 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype I (post-vaccination; N=49,48,82,94) | 1988 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype II (pre-vaccination; N=49,48,83,91) | 34.2 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype II (post-vaccination; N=49,48,82,94) | 1566 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype III (pre-vaccination; N=49,48,83,93) | 40.6 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Homologous virus (pre-vaccination; N=49,48,86,90) | 5.78 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype IV (pre-vaccination; N=49,48,83,90) | 5.00 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype III (pre-vaccination; N=49,48,83,93) | 5.00 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype I (post-vaccination; N=49,48,82,94) | 170 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype II (pre-vaccination; N=49,48,83,91) | 5.00 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype III (post-vaccination; N=49,48,82,94) | 189 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype II (post-vaccination; N=49,48,82,94) | 157 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Homologous virus (post-vaccination; N=49,48,84,93) | 500 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype IV (post-vaccination; N=49,48,82,94) | 25.3 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype I (pre-vaccination; N=49,48,83,91) | 5.00 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype IV (pre-vaccination; N=49,48,83,90) | 5.00 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype I (pre-vaccination; N=49,48,83,91) | 5.00 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Homologous virus (pre-vaccination; N=49,48,86,90) | 5.08 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype IV (post-vaccination; N=49,48,82,94) | 17.0 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype II (post-vaccination; N=49,48,82,94) | 121 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype I (post-vaccination; N=49,48,82,94) | 155 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype III (post-vaccination; N=49,48,82,94) | 98.2 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype III (pre-vaccination; N=49,48,83,93) | 5.00 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Homologous virus (post-vaccination; N=49,48,84,93) | 167 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination | Genotype II (pre-vaccination; N=49,48,83,91) | 5.00 Titers |
Other Pre-specified
Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine
Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Time frame: Day 0 (pre-vaccination) up to 5 years after final vaccination
Population: Geometric Mean Titers Against JE Antibodies were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (post-vaccination; N=49,50,96,97) | 1107.1 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (pre-vaccination; N=49,50,97,95) | 46.5 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-1 year; N=48,45,91,89) | 339 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (pre-vaccination; N=50,50,97,97) | 37.6 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (post-vaccination; N=49,50,96,97) | 920.6 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (pre-vaccination; N=50,50,100,94) | 48.6 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (post-6 months; N=47,48,99,98) | 581.2 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-vaccination; N=49,50,98,96) | 1956.7 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (post-vaccination; N=49,50,96,97) | 604.0 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-2 years; N=43,41,85,79) | 414 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-3 years; N=40,38,68,56) | 422 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (pre-vaccination; N=49,50,97,94) | 25.2 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-4 years; N=41,36,63,56) | 360 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (post-6 months; N=47,48,99,98) | 279.4 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-5 years; N=40,38,60,50) | 222 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-6 months; N=48,49,99,98) | 892.1 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (post-6 months; N=48,48,99,98) | 513.1 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (pre-vaccination; N=50,50,97,95) | 54.8 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (post-vaccination; N=49,50,96,97) | 1015.8 Titers |
| JE-CV/Hepatitis A (Group 1) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (6-months; N=47,48,99,98) | 863.5 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (post-vaccination; N=49,50,96,97) | 2210.4 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (6-months; N=47,48,99,98) | 981.0 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (post-vaccination; N=49,50,96,97) | 874.0 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (pre-vaccination; N=50,50,97,97) | 41.1 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-3 years; N=40,38,68,56) | 505 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (pre-vaccination; N=49,50,97,95) | 33.3 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (pre-vaccination; N=50,50,100,94) | 41.1 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (post-6 months; N=47,48,99,98) | 363.4 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (post-vaccination; N=49,50,96,97) | 2116.7 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (post-vaccination; N=49,50,96,97) | 1763.4 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-4 years; N=41,36,63,56) | 559 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (post-6 months; N=47,48,99,98) | 714.4 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (pre-vaccination; N=50,50,97,95) | 55.3 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-1 year; N=48,45,91,89) | 621 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (post-6 months; N=48,48,99,98) | 645.7 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-6 months; N=48,49,99,98) | 1244.3 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-5 years; N=40,38,60,50) | 287 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-2 years; N=43,41,85,79) | 662 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-vaccination; N=49,50,98,96) | 3722.2 Titers |
| Hepatitis A/JE-CV (Group 2) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (pre-vaccination; N=49,50,97,94) | 19.7 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (post-vaccination; N=49,50,96,97) | 163.2 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (pre-vaccination; N=50,50,100,94) | 6.11 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-vaccination; N=49,50,98,96) | 517.6 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-6 months; N=48,49,99,98) | 96.6 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-1 year; N=48,45,91,89) | 78.8 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-2 years; N=43,41,85,79) | 94.2 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-3 years; N=40,38,68,56) | 146 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-4 years; N=41,36,63,56) | 137 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-5 years; N=40,38,60,50) | 68.8 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (pre-vaccination; N=50,50,97,95) | 5.62 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (post-vaccination; N=49,50,96,97) | 186.8 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (6-months; N=47,48,99,98) | 81.4 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (pre-vaccination; N=49,50,97,95) | 5.75 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (post-6 months; N=47,48,99,98) | 72.3 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (pre-vaccination; N=50,50,97,97) | 5.39 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (post-vaccination; N=49,50,96,97) | 200.2 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (post-6 months; N=48,48,99,98) | 31.1 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (pre-vaccination; N=49,50,97,94) | 5.31 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (post-vaccination; N=49,50,96,97) | 28.5 Titers |
| JE-CV/Hepatitis A (Group 3) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (post-6 months; N=47,48,99,98) | 21.0 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (post-vaccination; N=49,50,96,97) | 163.1 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (pre-vaccination; N=50,50,97,95) | 5.18 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (post-vaccination; N=49,50,96,97) | 18.1 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (post-vaccination; N=49,50,96,97) | 102.1 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-5 years; N=40,38,60,50) | 58.2 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-4 years; N=41,36,63,56) | 110 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-vaccination; N=49,50,98,96) | 167.1 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (post-6 months; N=48,48,99,98) | 20.2 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-3 years; N=40,38,68,56) | 90.5 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-2 years; N=43,41,85,79) | 67.1 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (pre-vaccination; N=50,50,100,94) | 5.15 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (pre-vaccination; N=49,50,97,94) | 5.00 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-1 year; N=48,45,91,89) | 49.0 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (post-vaccination; N=49,50,96,97) | 126.8 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Homologous virus (post-6 months; N=48,49,99,98) | 49.8 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (post-6 months; N=47,48,99,98) | 42.4 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype II (pre-vaccination; N=49,50,97,95) | 5.20 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype I (6-months; N=47,48,99,98) | 52.4 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype IV (post-6 months; N=47,48,99,98) | 12.6 Titers |
| Hepatitis A/JE-CV (Group 4) | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine | Genotype III (pre-vaccination; N=50,50,97,97) | 5.08 Titers |
Other Pre-specified
Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination
Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Time frame: Day 0 (pre-vaccination) up to 5 years after final vaccination
Population: Persistence of seroprotection to JE-CV antigens was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-5 years; N=40,38,60,50) | 40 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (post-6 months; N=47,48,99,98) | 47 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (post-vaccination; N=49,50,96,97) | 48 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (pre-vaccination; N=50,50,97,97) | 41 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-4 years; N=41,36,63,56) | 41 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (pre-vaccination; N=49,50,97,94) | 39 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (post-vaccination; N=49,50,96,97) | 49 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (post-6 months; N=47,48,99,98) | 47 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (pre-vaccination; N=50,50,97,95) | 40 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-3 years; N=40,38,68,56) | 40 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-2 years; N=43,41,85,79) | 41 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (pre-vaccination; N=49,50,97,95) | 39 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (post-vaccination; N=49,50,96,97) | 49 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-1 year; N=48,45,91,89) | 46 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-6 months; N=48,49,99,98) | 48 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (post-vaccination; N=49,50,96,97) | 49 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (post-6 months; N=48,48,99,98) | 48 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-vaccination; N=49,50,98,96) | 49 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (pre-vaccination; N=50,50,100,94) | 45 Participants |
| JE-CV/Hepatitis A (Group 1) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (post-6 months; N=47,48,99,98) | 47 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (pre-vaccination; N=50,50,97,95) | 41 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (post-vaccination; N=49,50,96,97) | 50 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (post-6 months; N=47,48,99,98) | 48 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (pre-vaccination; N=49,50,97,95) | 39 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (post-vaccination; N=49,50,96,97) | 50 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (post-6 months; N=47,48,99,98) | 48 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (pre-vaccination; N=50,50,97,97) | 38 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (post-vaccination; N=49,50,96,97) | 50 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (post-6 months; N=48,48,99,98) | 48 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (pre-vaccination; N=49,50,97,94) | 32 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (post-vaccination; N=49,50,96,97) | 50 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (post-6 months; N=47,48,99,98) | 48 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (pre-vaccination; N=50,50,100,94) | 41 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-vaccination; N=49,50,98,96) | 50 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-6 months; N=48,49,99,98) | 49 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-1 year; N=48,45,91,89) | 44 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-2 years; N=43,41,85,79) | 41 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-3 years; N=40,38,68,56) | 38 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-4 years; N=41,36,63,56) | 36 Participants |
| Hepatitis A/JE-CV (Group 2) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-5 years; N=40,38,60,50) | 38 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (post-vaccination; N=49,50,96,97) | 73 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (post-6 months; N=47,48,99,98) | 90 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (post-6 months; N=47,48,99,98) | 68 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (pre-vaccination; N=50,50,100,94) | 15 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (post-vaccination; N=49,50,96,97) | 93 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-vaccination; N=49,50,98,96) | 98 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (post-vaccination; N=49,50,96,97) | 95 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-4 years; N=41,36,63,56) | 63 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-6 months; N=48,49,99,98) | 91 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (pre-vaccination; N=49,50,97,95) | 9 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (pre-vaccination; N=50,50,97,95) | 8 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-1 year; N=48,45,91,89) | 81 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-5 years; N=40,38,60,50) | 55 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-2 years; N=43,41,85,79) | 74 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (post-6 months; N=47,48,99,98) | 95 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (post-vaccination; N=49,50,96,97) | 96 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (post-6 months; N=48,48,99,98) | 73 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (pre-vaccination; N=50,50,97,97) | 5 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-3 years; N=40,38,68,56) | 66 Participants |
| JE-CV/Hepatitis A (Group 3) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (pre-vaccination; N=49,50,97,94) | 5 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (post-vaccination; N=49,50,96,97) | 92 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (post-vaccination; N=49,50,96,97) | 65 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-5 years; N=40,38,60,50) | 44 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (post-vaccination; N=49,50,96,97) | 93 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-1 year; N=48,45,91,89) | 71 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (post-6 months; N=47,48,99,98) | 46 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (post-vaccination; N=49,50,96,97) | 93 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (pre-vaccination; N=50,50,97,95) | 3 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype I (post-6 months; N=47,48,99,98) | 86 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (pre-vaccination; N=50,50,100,94) | 2 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-3 years; N=40,38,68,56) | 52 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-4 years; N=41,36,63,56) | 54 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (post-6 months; N=48,48,99,98) | 62 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-vaccination; N=49,50,98,96) | 89 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (pre-vaccination; N=49,50,97,95) | 2 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-2 years; N=43,41,85,79) | 64 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype III (pre-vaccination; N=50,50,97,97) | 1 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype IV (pre-vaccination; N=49,50,97,94) | 0 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Homologous virus (post-6 months; N=48,49,99,98) | 80 Participants |
| Hepatitis A/JE-CV (Group 4) | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination | Genotype II (post-6 months; N=47,48,99,98) | 80 Participants |