CompletedNCT00441259Updated Aug 27, 2012Results posted

Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

A Phase 2 interventional study of ChimeriVax™-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine in Japanese Encephalitis, sponsored by Sanofi. Completed at 3 sites in India. Open to participants aged 9 Months to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-27.

Sponsored by Sanofi · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 96
Allocation: Randomized
Ages: 9 Months to 10 Years
Sex: All

Study summary

This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period.

Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.

Conditions studied

Japanese Encephalitis

Browse trials for

Keywords

Japanese Encephalitis

In context

Encephalitis, Japanese

77 studies on the registry are indexed under Encephalitis, Japanese; 4 are open to participants now.

This study's enrollment of 96 is below the median of 278 across 69 interventional studies indexed under Encephalitis, Japanese.

Browse Encephalitis, Japanese studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 9 Months to 10 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

All aspects of the Protocol explained and written informed consent obtained from the subject's parent or guardian and assent from the child if ≥ 8 years of age.
Aged ≥ 9 months to \< 10 years
In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results
Subject had to be available for the study duration for the study duration, including all planned follow-up visits.

Exclusion criteria

Exclusion Criteria:

A history of vaccination against, or infection with, JE or other flaviviruses (e.g. Kyanasur Forest Disease, West Nile virus, dengue fever). Previous JE vaccination was to be determined by history (interview of subject's parent or guardian) or by inspecting the child's official vaccination record.
Demonstration of parasitemia on malaria blood smear at Screening.
History of residence in or travel to a JE-endemic region of India or elsewhere in Asia (for periods of 4 weeks or more).
hypersensitivity to thimerosal or gelatin
Have received a transfusion of blood, blood products or serum globulin in the preceding 6 months,
Have an immunodeficiency or neurological disorder, or take drugs that suppress the immune system,
Have a history of severe reaction to other vaccines,
Have a chronic condition requiring medication,
Intend to travel out of the area during the study period,
Have spent at least 4 weeks in a JE-endemic region,
Plan to receive any other vaccination within the double-blind treatment period, or who have received a vaccination in the month preceding Screening,
Exhibit signs of secondary or tertiary malnutrition,
Are seropositive to human immunodeficiency virus (HIV), Hepatitis B or C,
Have malaria infection, or who have a fever within 3 days before vaccination.
Those with an acute fever, or with previously scheduled vaccinations, may be rescheduled.
Consideration of the routine immunisation schedule should be made such that it is ensured that routine vaccinations due are either given before entry to the trial, or afterwards if delayed because of the trial.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 96 participants (actual)

Study arms

Experimental
JE-CV Group
Participants will receive Japanese encephalitis chimeric virus vaccine (JE-CV)
Biological: ChimeriVax™-JE
Active comparator
MBDV Group
Participants will receive the mouse brain-derived vaccine (MBDV)
Biological: Japanese Encephalitis Inactivated Mouse Brain Vaccine

Interventions

BiologicalChimeriVax™-JE
One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged \> 3 years and 0.5 ml to children and infants aged \< 3 years administered subcutaneously
BiologicalJapanese Encephalitis Inactivated Mouse Brain Vaccine
Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged \> 3 years and 0.5 ml is given to children and infants aged \< 3 years administered subcutaneously

What researchers measure

Primary outcomes

Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time frame: Day 14 up to Day 42 Post-vaccination
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time frame: Day 14 up to Day 42 Post-vaccination
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
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).
Time frame: Day 42 Post-vaccination
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
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).
Time frame: Day 42 Post Dose 1

Secondary outcomes

Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
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).
Time frame: Day 42 Post Dose 1
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
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).
Time frame: Day 42 Post-vaccination

Results

Posted Aug 27, 2012

Participant flow

Participants were enrolled and vaccinated from 03 January 2007 to 13 January 2009 at 3 clinical centers in India.

Participant flow — Overall Study
Milestone	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Started	48	48
Completed	48	48
Not completed	0	0

Outcome measures

PrimaryNumber of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

Time frame:: Day 14 up to Day 42 Post-vaccination
Reported as:: Number · Participants

Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Participants	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Nasopharyngitis (All; N = 48, 48)	2	2 (0 to 0)
Otitis Media Acute (All; N = 48, 48)	1	0 (0 to 0)
Diarrhea Infectious (All; N = 48, 48)	1	0 (0 to 0)
Dysentery (All; N = 48, 48)	1	0 (0 to 0)
Hepatitis A (All; N = 48, 48)	1	0 (0 to 0)
Rash Pustular (All; N = 48, 48)	1	0 (0 to 0)
Tonsillitis (All; N = 48, 48)	1	0 (0 to 0)
Upper Respiratory Tract Infection (All; N=48, 48)	1	0 (0 to 0)
Varicella (All; N = 48, 48)	1	0 (0 to 0)
Impetigo (All; N = 48, 48)	0	1 (0 to 0)
Pharyngitis (All; N = 48, 48)	0	1 (0 to 0)
Viral Upper Respiratory Tract Infect. (All;N=48,48	0	1 (0 to 0)
Diarrhea (All; N = 48, 48)	3	2 (0 to 0)
Vomiting (All; N = 48, 48)	2	1 (0 to 0)
Haematochezia (All; N = 48, 48)	1	0 (0 to 0)
Mucous Stools (All; N = 48, 48)	1	0 (0 to 0)
Constipation (All; N = 48, 48)	0	1 (0 to 0)
Rhinorrhea (All; N = 48, 48)	3	3 (0 to 0)
Cough (All; N = 48, 48)	2	2 (0 to 0)
Wheezing (All; N = 48, 48)	0	2 (0 to 0)
Pyrexia (All; N = 48, 48)	2	1 (0 to 0)
Face Edema (All; N = 48, 48)	1	0 (0 to 0)
Injection Site Pain (All; N = 48, 48)	1	2 (0 to 0)
Injection Site Swelling (All; N = 48, 48)	0	1 (0 to 0)
Malaise (All; N = 48, 48)	1	1 (0 to 0)
Pain (All; N = 48, 48)	1	0 (0 to 0)
Irritability (All; N = 48, 48)	0	2 (0 to 0)
Anorexia (All; N = 48, 48)	2	1 (0 to 0)
Anemia (All; N = 48, 48)	2	2 (0 to 0)
Eosinophilia (All; N = 48, 48)	0	1 (0 to 0)
Lacrimation Increased (All; N = 48, 48)	0	1 (0 to 0)
Laziness (All; N = 48, 48)	2	1 (0 to 0)
Erythema (All; N = 48, 48)	1	0 (0 to 0)
Rash (All; N = 48, 48)	1	0 (0 to 0)
Injury (All; N = 48, 48)	1	0 (0 to 0)
Eosinophil Count Increased (All; N = 48, 48)	0	1 (0 to 0)
Hemoglobin Decreased (All; N = 48, 48)	1	0 (0 to 0)
Pyrexia (≥5 to <10 yr; N = 16, 16)	2	0 (0 to 0)
Injection Site Pain (≥5 to <10 yr; N = 16, 16)	1	0 (0 to 0)
Pain (≥5 to <10 yr; N = 16, 16)	1	0 (0 to 0)
Upper Respiratory Tract Infection (≥5 to <10 yr;	1	0 (0 to 0)
Eosinophil Count Increased (≥5 to <10 yr; N=16, 16	0	1 (0 to 0)
Otitis Media Acute (≥2 to <5 yr: N=16, 16)	1	0 (0 to 0)
Diarrhea Infectious (≥2 to <5 yr: N=16, 16)	1	0 (0 to 0)
Hepatitis A (≥2 to <5 yr: N=16, 16)	1	0 (0 to 0)
Rash Pustular (≥2 to <5 yr: N=16, 16)	1	0 (0 to 0)
Tonsillitis (≥2 to <5 yr: N=16, 16)	1	0 (0 to 0)
Varicella (≥2 to <5 yr: N=16, 16)	1	0 (0 to 0)
Vomiting (≥2 to <5 yr: N=16, 16)	1	0 (0 to 0)
Injection Site Pain (≥2 to <5 yr: N=16, 16)	0	1 (0 to 0)
Injection Site Swelling (≥2 to <5 yr: N=16, 16)	0	1 (0 to 0)
Pyrexia (≥2 to <5 yr: N=16, 16)	0	1 (0 to 0)
Rhinorrhea (≥2 to <5 yr: N=16, 16)	1	0 (0 to 0)
Diarrhea (≥9 mo to <2 yr; N = 16, 16)	3	2 (0 to 0)
Vomiting (≥9 mo to <2 yr; N = 16, 16)	1	1 (0 to 0)
Haematochezia (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)
Mucous Stools (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)
Constipation (≥9 mo to <2 yr; N = 16, 16)	0	1 (0 to 0)
Cough (≥9 mo to <2 yr; N = 16, 16)	2	2 (0 to 0)
Rhinorrhea (≥9 mo to <2 yr; N = 16, 16)	2	3 (0 to 0)
Wheezing (≥9 mo to <2 yr; N = 16, 16)	0	2 (0 to 0)
Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16)	2	2 (0 to 0)
Dysentery (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)
Impetigo (≥9 mo to <2 yr; N = 16, 16)	0	1 (0 to 0)
Pharyngitis (≥9 mo to <2 yr; N = 16, 16)	0	1 (0 to 0)
Viral Upper Respiratory Tract Inf (≥9 mo to <2 yr)	0	1 (0 to 0)
Anorexia (≥9 mo to <2 yr; N = 16, 16)	2	1 (0 to 0)
Anemia (≥9 mo to <2 yr; N = 16, 16)	2	2 (0 to 0)
Eosinophilia (≥9 mo to <2 yr; N = 16, 16)	0	1 (0 to 0)
Irritability (≥9 mo to <2 yr; N = 16, 16)	0	2 (0 to 0)
Face Edema (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)
Malaise (≥9 mo to <2 yr; N = 16, 16)	1	1 (0 to 0)
Injection Site Pain (≥9 mo to <2 yr; N = 16, 16)	0	1 (0 to 0)
Laziness (≥9 mo to <2 yr; N = 16, 16)	2	1 (0 to 0)
Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16)	0	1 (0 to 0)
Erythema (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)
Rash (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)
Injury (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)
Hemoglobin Decreased (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)

PrimaryNumber of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

Time frame:: Day 14 up to Day 42 Post-vaccination
Reported as:: Number · Participants

Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Participants	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Nasopharyngitis (All; N = 48, 48)	2	2 (0 to 0)
Upper Respiratory Tract Infection (All; N =48, 48)	1	0 (0 to 0)
Impetigo (All; N = 48, 48)	0	1 (0 to 0)
Pharyngitis (All; N = 48, 48)	0	1 (0 to 0)
Diarrhea (All; N = 48, 48)	1	2 (0 to 0)
Vomiting (All; N = 48, 48)	1	1 (0 to 0)
Hematochezia (All; N = 48, 48)	1	0 (0 to 0)
Mucous Stools (All; N = 48, 48)	1	0 (0 to 0)
Rhinorrhea (All; N = 48, 48)	1	3 (0 to 0)
Cough (All; N = 48, 48)	2	2 (0 to 0)
Wheezing (All; N = 48, 48)	0	2 (0 to 0)
Pyrexia (All; N = 48, 48)	2	0 (0 to 0)
Injection Site Pain (All; N = 48, 48)	1	2 (0 to 0)
Injection Site Swelling (All; N = 48, 48)	0	1 (0 to 0)
Malaise (All; N = 48, 48)	1	0 (0 to 0)
Pain (All; N = 48, 48)	1	0 (0 to 0)
Irritability (All; N = 48, 48)	0	1 (0 to 0)
Anorexia (All; N = 48, 48)	1	1 (0 to 0)
Anemia (All; N = 48, 48)	1	0 (0 to 0)
Lacrimation Increased (All; N = 48, 48)	0	1 (0 to 0)
Rash (All; N = 48, 48)	1	0 (0 to 0)
Pyrexia (≥5 to <10 yr; N = 16, 16)	2	0 (0 to 0)
Injection Site Pain (≥5 to <10 yr; N = 16, 16)	1	0 (0 to 0)
Pain (≥5 to <10 yr; N = 16, 16)	1	0 (0 to 0)
Upper Respiratory Tract Infection (≥5 to <10 yr)	1	0 (0 to 0)
Injection Site Pain (≥2 to <5 yr; N = 16, 16)	0	1 (0 to 0)
Injection Site Swelling (≥2 to <5 yr; N = 16, 16)	0	1 (0 to 0)
Diarrhea (≥9 mo to <2 yr; N = 16, 16)	1	2 (0 to 0)
Vomiting (≥9 mo to <2 yr; N = 16, 16)	1	1 (0 to 0)
Hematochezia (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)
Mucous Stools (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)
Cough (≥9 mo to <2 yr; N = 16, 16)	2	2 (0 to 0)
Rhinorrhea(≥9 mo to <2 yr; N = 16, 16)	1	3 (0 to 0)
Wheezing (≥9 mo to <2 yr; N = 16, 16)	0	2 (0 to 0)
Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16)	2	2 (0 to 0)
Impetigo (≥9 mo to <2 yr; N = 16, 16)	0	1 (0 to 0)
Pharyngitis (≥9 mo to <2 yr; N = 16, 16)	0	1 (0 to 0)
Anorexia (≥9 mo to <2 yr; N = 16, 16)	1	1 (0 to 0)
Anemia (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)
Irritability (≥9 mo to <2 yr; N = 16, 16)	0	1 (0 to 0)
Malaise (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)
Injection Site Pain (≥9 mo to <2 yr; N = 16, 16)	0	1 (0 to 0)
Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16)	0	1 (0 to 0)
Rash (≥9 mo to <2 yr; N = 16, 16)	1	0 (0 to 0)

PrimaryNumber of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

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).

Time frame:: Day 42 Post-vaccination
Reported as:: Number · Participants

Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Participants	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Homologous JE-CV virus PRNT (N = 33, 0)	33	NA (0 to 0)
Homologous virus Nakayama strain PRNT (N = 0, 35)	NA	8
JE-CV PRNT (N = 33, 35)	33	33 (0 to 0)
Nakayama PRNT (N = 32, 35)	8	8 (0 to 0)
Indian WT virus PRNT (N = 33, 35)	27	26 (0 to 0)

PrimaryGeometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

Time frame:: Day 42 Post Dose 1
Reported as:: Geometric mean · Titers

Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Titers	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Homologous JE-CV virus PRNT (N = 34, 0)	313.5 (40 to 5120)	NA (NA to NA)
Homologous virus Nakayama strain PRNT (N = 0, 35)	NA (NA to NA)	8.0 (5 to 160)
JE-CV PRNT (N = 34, 35)	313.5 (40 to 5120)	49.7 (5 to 320)
Nakayama PRNT (N = 33, 35)	7.8 (5 to 160)	8.0 (5 to 160)
Indian WT virus PRNT (N = 34, 35)	60.1 (5 to 2560)	17.1 (5 to 320)

SecondaryNumber of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

Time frame:: Day 42 Post Dose 1
Reported as:: Number · Participants

Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Participants	ChimeriVax™-JE	Mouse Brain Derived Vaccine
Homologous JE-CV virus PRNT (N = 33, 0)	33	NA (0 to 0)
Homologous virus Nakayama strain PRNT (N=0,35)	NA	8
JE-CV Virus (All; N = 33, 35)	33	33 (0 to 0)
Nakayama Strain (All; N = 32, 35)	8	8 (0 to 0)
Wild Type Virus (All; N = 33, 35)	27	26 (0 to 0)
JE-CV Virus (≥5 to <10 yr; N = 12, 13)	12	12 (0 to 0)
JE Virus Nakayama strain (≥5 to <10 yr; N =12, 13)	6	0 (0 to 0)
Wild Type Virus (≥5 to <10 yr; N = 12, 13)	12	11 (0 to 0)
JE-CV Virus (≥2 to <5 yr; N = 8, 9)	8	9 (0 to 0)
JE Virus Nakayama strain (≥2 to <5 yr; N = 9, 9)	1	6 (0 to 0)
Wild Type Virus (≥2 to <5 yr; N = 8, 9)	2	6 (0 to 0)
JE-CV Virus (≥9 mo to <2 yr; N = 13, 13)	13	12 (0 to 0)
JE Virus Nakayama (≥9 mo to <2 yr; N = 11, 13)	1	2 (0 to 0)
Wild Type Virus (≥9 mo to <2 yr; N=13, 13)	13	9 (0 to 0)

SecondaryGeometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

Time frame:: Day 42 Post-vaccination
Reported as:: Geometric mean · Titers

Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Titers	ChimeriVax™-JE	Mouse Brain Derived Vaccine
JE-CV Virus (All; N = 34, 35)	313.5 (40 to 5120)	49.7 (5 to 320)
JE Nakayama Strain (All; N = 33, 35)	7.8 (5 to 160)	8.0 (5 to 160)
Wild Type Virus (All; N = 34, 35)	60.1 (5 to 2560)	17.1 (5 to 320)
JE-CV Virus (≥5 to <10 yr; N = 12, 13)	226.3 (80 to 5120)	34.1 (5 to 160)
JE Virus Nakayama Strain (≥5 to <10 yr; N =12, 13)	13.3 (5 to 160)	5.0 (5 to 5)
Wild Type virus (≥5 to <10 yr; N = 12, 13)	100.8 (10 to 2560)	17.0 (5 to 40)
JE-CV Virus (≥2 to <5 yr; N = 9, 9)	254.0 (80 to 1280)	74.1 (40 to 160)
JE Virus Nakayama Strain (≥2 to <5 yr; N = 9, 9)	6.3 (5 to 40)	27.2 (5 to 160)
Wild Type Virus (≥2 to <5 yr; N = 9, 9)	9.3 (5 to 40)	17.1 (5 to 80)
JE-CV Virus (≥9 mo to <2 yr; N = 13, 13)	490.2 (40 to 5120)	55.1 (5 to 320)
JE Virus Nakayama (≥9 mo to <2 yr; N = 12, 13)	5.3 (5 to 10)	5.6 (5 to 10)
Wild Type Virus (≥9 mo to <2 yr; N = 13, 13)	136.3 (10 to 1280)	17.0 (5 to 320)

Adverse events

Collected over Adverse events were assessed from Day 14 to Day 42 (up to 28 days after completion of the course of vaccination).. Non-serious events are listed at a 5.00% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ChimeriVax™-JE	—	0/48 (0%)	6/48 (12.5%)
Mouse Brain Derived Vaccine	—	0/48 (0%)	5/48 (10.4%)

Most frequent other events

Most frequent other events
Event	ChimeriVax™-JE	Mouse Brain Derived Vaccine
DiarrheaGastrointestinal disorders	3/48	2/48
RhinorrheaRespiratory, thoracic and mediastinal disorders	3/48	3/48

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	ChimeriVax™-JE	Mouse Brain Derived Vaccine	Total
<=18 years	48	48	96
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Age Continuous
Age Continuous(Years)	ChimeriVax™-JE	Mouse Brain Derived Vaccine	Total
Mean	3.8 ± 2.98	3.7 ± 2.89	3.7 ± 2.52

Sex: Female, Male
Sex: Female, Male(Participants)	ChimeriVax™-JE	Mouse Brain Derived Vaccine	Total
Female	27	21	48
Male	21	27	48

Region of Enrollment
Region of Enrollment(Participants)	ChimeriVax™-JE	Mouse Brain Derived Vaccine	Total
India	48	48	96

Study locations

3 sites

Dr Atul's Child Hospital
Jaipur, Rajasthan 302016, India
Government Medical College
Baroda, 390001, India
Maulana Azad Medical College
New Delhi, 110002, India

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00441259
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Feb 28, 2007
Start date: Jan 2007
Primary completion: Feb 2011
Completion: Dec 2011
Results posted: Aug 27, 2012
Last update: Aug 27, 2012

Study contacts

Anand Dubey, M.D

principal investigator · Maulana Azad Medical College, New Delhi, India

Bakul B. Javadekar, M.D.

principal investigator · Government Medical College, Baroda, India

Atul Shanker, Dr.

principal investigator · Dr Atul's Child Hospital, Jaipur, Rajasthan, India

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Encephalitis, Japanese→

Other studies from this sponsor

Sanofi

Start the discussion