Trial Outcomes & Findings for Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age (NCT NCT00441259)
NCT ID: NCT00441259
Last Updated: 2012-08-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Day 14 up to Day 42 Post-vaccination
Results posted on
2012-08-27
Participant Flow
Participants were enrolled and vaccinated from 03 January 2007 to 13 January 2009 at 3 clinical centers in India.
A total of 96 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
ChimeriVax™-JE
Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
|
Mouse Brain Derived Vaccine
Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
COMPLETED
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age
Baseline characteristics by cohort
| Measure |
ChimeriVax™-JE
n=48 Participants
Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
|
Mouse Brain Derived Vaccine
n=48 Participants
Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
3.8 Years
STANDARD_DEVIATION 2.98 • n=5 Participants
|
3.7 Years
STANDARD_DEVIATION 2.89 • n=7 Participants
|
3.7 Years
STANDARD_DEVIATION 2.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14 up to Day 42 Post-vaccinationPopulation: Adverse events were assessed in all enrolled participants, intent-to-treat (safety) population.
Outcome measures
| Measure |
ChimeriVax™-JE
n=48 Participants
Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
|
Mouse Brain Derived Vaccine
n=48 Participants
Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Nasopharyngitis (All; N = 48, 48)
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Otitis Media Acute (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Diarrhea Infectious (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Dysentery (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Hepatitis A (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Rash Pustular (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Tonsillitis (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Upper Respiratory Tract Infection (All; N=48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Varicella (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Impetigo (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pharyngitis (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Viral Upper Respiratory Tract Infect. (All;N=48,48
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Diarrhea (All; N = 48, 48)
|
3 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Vomiting (All; N = 48, 48)
|
2 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Haematochezia (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Mucous Stools (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Constipation (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Rhinorrhea (All; N = 48, 48)
|
3 Participants
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Cough (All; N = 48, 48)
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wheezing (All; N = 48, 48)
|
0 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pyrexia (All; N = 48, 48)
|
2 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Face Edema (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Pain (All; N = 48, 48)
|
1 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Swelling (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Malaise (All; N = 48, 48)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pain (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Irritability (All; N = 48, 48)
|
0 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Anorexia (All; N = 48, 48)
|
2 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Anemia (All; N = 48, 48)
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Eosinophilia (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Lacrimation Increased (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Laziness (All; N = 48, 48)
|
2 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Erythema (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Rash (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injury (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Eosinophil Count Increased (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Hemoglobin Decreased (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pyrexia (≥5 to <10 yr; N = 16, 16)
|
2 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Pain (≥5 to <10 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pain (≥5 to <10 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Upper Respiratory Tract Infection (≥5 to <10 yr;
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Eosinophil Count Increased (≥5 to <10 yr; N=16, 16
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Otitis Media Acute (≥2 to <5 yr: N=16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Diarrhea Infectious (≥2 to <5 yr: N=16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Hepatitis A (≥2 to <5 yr: N=16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Rash Pustular (≥2 to <5 yr: N=16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Tonsillitis (≥2 to <5 yr: N=16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Varicella (≥2 to <5 yr: N=16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Vomiting (≥2 to <5 yr: N=16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Pain (≥2 to <5 yr: N=16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Swelling (≥2 to <5 yr: N=16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pyrexia (≥2 to <5 yr: N=16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Rhinorrhea (≥2 to <5 yr: N=16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Diarrhea (≥9 mo to <2 yr; N = 16, 16)
|
3 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Vomiting (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Haematochezia (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Mucous Stools (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Constipation (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Cough (≥9 mo to <2 yr; N = 16, 16)
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Rhinorrhea (≥9 mo to <2 yr; N = 16, 16)
|
2 Participants
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wheezing (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16)
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Dysentery (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Impetigo (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pharyngitis (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Viral Upper Respiratory Tract Inf (≥9 mo to <2 yr)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Anorexia (≥9 mo to <2 yr; N = 16, 16)
|
2 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Anemia (≥9 mo to <2 yr; N = 16, 16)
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Eosinophilia (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Irritability (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Face Edema (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Malaise (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Pain (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Laziness (≥9 mo to <2 yr; N = 16, 16)
|
2 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Erythema (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Rash (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injury (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Hemoglobin Decreased (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 14 up to Day 42 Post-vaccinationPopulation: Adverse events were assessed all enrolled and vaccinated participants, intent-to-treat (safety) population.
Outcome measures
| Measure |
ChimeriVax™-JE
n=48 Participants
Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
|
Mouse Brain Derived Vaccine
n=48 Participants
Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
|
|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Nasopharyngitis (All; N = 48, 48)
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Upper Respiratory Tract Infection (All; N =48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Impetigo (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pharyngitis (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Diarrhea (All; N = 48, 48)
|
1 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Vomiting (All; N = 48, 48)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Hematochezia (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Mucous Stools (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Rhinorrhea (All; N = 48, 48)
|
1 Participants
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Cough (All; N = 48, 48)
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wheezing (All; N = 48, 48)
|
0 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pyrexia (All; N = 48, 48)
|
2 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Pain (All; N = 48, 48)
|
1 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Swelling (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Malaise (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pain (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Irritability (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Anorexia (All; N = 48, 48)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Anemia (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Lacrimation Increased (All; N = 48, 48)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Rash (All; N = 48, 48)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pyrexia (≥5 to <10 yr; N = 16, 16)
|
2 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Pain (≥5 to <10 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pain (≥5 to <10 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Upper Respiratory Tract Infection (≥5 to <10 yr)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Pain (≥2 to <5 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Swelling (≥2 to <5 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Diarrhea (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Vomiting (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Hematochezia (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Mucous Stools (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Cough (≥9 mo to <2 yr; N = 16, 16)
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Rhinorrhea(≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wheezing (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16)
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Impetigo (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Pharyngitis (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Anorexia (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Anemia (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Irritability (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Malaise (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Injection Site Pain (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Rash (≥9 mo to <2 yr; N = 16, 16)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 42 Post-vaccinationPopulation: Seroconversion was assessed all participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination samples (Day 42) for antibody analysis, per-protocol population.
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Outcome measures
| Measure |
ChimeriVax™-JE
n=33 Participants
Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
|
Mouse Brain Derived Vaccine
n=35 Participants
Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
|
|---|---|---|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Homologous JE-CV virus PRNT (N = 33, 0)
|
33 Participants
|
NA Participants
Interval 0.0 to 0.0
Homologous JE-CV virus PRNT used for the assessment of the immune response in ChimeriVax™-JE Vaccine recipients only
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Homologous virus Nakayama strain PRNT (N = 0, 35)
|
NA Participants
Homologous virus Nakayama strain used for the assessment of the immune response in Mouse Brain Derived Vaccine recipients only
|
8 Participants
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE-CV PRNT (N = 33, 35)
|
33 Participants
|
33 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Nakayama PRNT (N = 32, 35)
|
8 Participants
|
8 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Indian WT virus PRNT (N = 33, 35)
|
27 Participants
|
26 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 42 Post Dose 1Population: Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Outcome measures
| Measure |
ChimeriVax™-JE
n=34 Participants
Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
|
Mouse Brain Derived Vaccine
n=35 Participants
Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Homologous JE-CV virus PRNT (N = 34, 0)
|
313.5 Titers
Interval 40.0 to 5120.0
|
NA Titers
Homologous JE-CV virus PRNT used for the assessment of the immune response in ChimeriVax™-JE Vaccine recipients only
|
|
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Homologous virus Nakayama strain PRNT (N = 0, 35)
|
NA Titers
Homologous virus Nakayama strain used for the assessment of the immune response in Mouse Brain Derived Vaccine recipients.
|
8.0 Titers
Interval 5.0 to 160.0
|
|
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE-CV PRNT (N = 34, 35)
|
313.5 Titers
Interval 40.0 to 5120.0
|
49.7 Titers
Interval 5.0 to 320.0
|
|
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Nakayama PRNT (N = 33, 35)
|
7.8 Titers
Interval 5.0 to 160.0
|
8.0 Titers
Interval 5.0 to 160.0
|
|
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Indian WT virus PRNT (N = 34, 35)
|
60.1 Titers
Interval 5.0 to 2560.0
|
17.1 Titers
Interval 5.0 to 320.0
|
SECONDARY outcome
Timeframe: Day 42 Post Dose 1Population: Seroprotection was assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Outcome measures
| Measure |
ChimeriVax™-JE
n=34 Participants
Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
|
Mouse Brain Derived Vaccine
n=35 Participants
Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
|
|---|---|---|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Homologous JE-CV virus PRNT (N = 33, 0)
|
33 Participants
|
NA Participants
Interval 0.0 to 0.0
Homologous JE-CV virus PRNT used for the assessment of the immune response in ChimeriVax™-JE Vaccine recipients only
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Homologous virus Nakayama strain PRNT (N=0,35)
|
NA Participants
Homologous virus Nakayama strain used for the assessment of the immune response in Mouse Brain Derived Vaccine recipients
|
8 Participants
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE-CV Virus (All; N = 33, 35)
|
33 Participants
|
33 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Nakayama Strain (All; N = 32, 35)
|
8 Participants
|
8 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wild Type Virus (All; N = 33, 35)
|
27 Participants
|
26 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE-CV Virus (≥5 to <10 yr; N = 12, 13)
|
12 Participants
|
12 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE Virus Nakayama strain (≥5 to <10 yr; N =12, 13)
|
6 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wild Type Virus (≥5 to <10 yr; N = 12, 13)
|
12 Participants
|
11 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE-CV Virus (≥2 to <5 yr; N = 8, 9)
|
8 Participants
|
9 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE Virus Nakayama strain (≥2 to <5 yr; N = 9, 9)
|
1 Participants
|
6 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wild Type Virus (≥2 to <5 yr; N = 8, 9)
|
2 Participants
|
6 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE-CV Virus (≥9 mo to <2 yr; N = 13, 13)
|
13 Participants
|
12 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE Virus Nakayama (≥9 mo to <2 yr; N = 11, 13)
|
1 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wild Type Virus (≥9 mo to <2 yr; N=13, 13)
|
13 Participants
|
9 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 42 Post-vaccinationPopulation: Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Outcome measures
| Measure |
ChimeriVax™-JE
n=34 Participants
Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
|
Mouse Brain Derived Vaccine
n=35 Participants
Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE-CV Virus (All; N = 34, 35)
|
313.5 Titers
Interval 40.0 to 5120.0
|
49.7 Titers
Interval 5.0 to 320.0
|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE Nakayama Strain (All; N = 33, 35)
|
7.8 Titers
Interval 5.0 to 160.0
|
8.0 Titers
Interval 5.0 to 160.0
|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wild Type Virus (All; N = 34, 35)
|
60.1 Titers
Interval 5.0 to 2560.0
|
17.1 Titers
Interval 5.0 to 320.0
|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE-CV Virus (≥5 to <10 yr; N = 12, 13)
|
226.3 Titers
Interval 80.0 to 5120.0
|
34.1 Titers
Interval 5.0 to 160.0
|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE Virus Nakayama Strain (≥5 to <10 yr; N =12, 13)
|
13.3 Titers
Interval 5.0 to 160.0
|
5.0 Titers
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wild Type virus (≥5 to <10 yr; N = 12, 13)
|
100.8 Titers
Interval 10.0 to 2560.0
|
17.0 Titers
Interval 5.0 to 40.0
|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE-CV Virus (≥2 to <5 yr; N = 9, 9)
|
254.0 Titers
Interval 80.0 to 1280.0
|
74.1 Titers
Interval 40.0 to 160.0
|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE Virus Nakayama Strain (≥2 to <5 yr; N = 9, 9)
|
6.3 Titers
Interval 5.0 to 40.0
|
27.2 Titers
Interval 5.0 to 160.0
|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wild Type Virus (≥2 to <5 yr; N = 9, 9)
|
9.3 Titers
Interval 5.0 to 40.0
|
17.1 Titers
Interval 5.0 to 80.0
|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE-CV Virus (≥9 mo to <2 yr; N = 13, 13)
|
490.2 Titers
Interval 40.0 to 5120.0
|
55.1 Titers
Interval 5.0 to 320.0
|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
JE Virus Nakayama (≥9 mo to <2 yr; N = 12, 13)
|
5.3 Titers
Interval 5.0 to 10.0
|
5.6 Titers
Interval 5.0 to 10.0
|
|
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Wild Type Virus (≥9 mo to <2 yr; N = 13, 13)
|
136.3 Titers
Interval 10.0 to 1280.0
|
17.0 Titers
Interval 5.0 to 320.0
|
Adverse Events
ChimeriVax™-JE
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Mouse Brain Derived Vaccine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ChimeriVax™-JE
n=48 participants at risk
Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
|
Mouse Brain Derived Vaccine
n=48 participants at risk
Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
3/48 • Number of events 3 • Adverse events were assessed from Day 14 to Day 42 (up to 28 days after completion of the course of vaccination).
|
4.2%
2/48 • Number of events 5 • Adverse events were assessed from Day 14 to Day 42 (up to 28 days after completion of the course of vaccination).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.2%
3/48 • Number of events 4 • Adverse events were assessed from Day 14 to Day 42 (up to 28 days after completion of the course of vaccination).
|
6.2%
3/48 • Number of events 7 • Adverse events were assessed from Day 14 to Day 42 (up to 28 days after completion of the course of vaccination).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER