Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age
Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00441259
Collaborator
(none)
96
3
2
59
32
0.5
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Randomised, Double Blind, Controlled, Safety, Tolerability and Immunogenicity Phase II Trial of ChimeriVax™-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine in Children of Descending Age.
Study Start Date
:
Jan 1, 2007
Actual Primary Completion Date
:
Feb 1, 2011
Actual Study Completion Date
:
Dec 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JE-CV Group Participants will receive Japanese encephalitis chimeric virus vaccine (JE-CV) |
Biological: ChimeriVax™-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
|
| Active Comparator: MBDV Group Participants will receive the mouse brain-derived vaccine (MBDV) |
Biological: Japanese 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
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine [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 [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 [Day 42 Post-vaccination]
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).
- Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine [Day 42 Post Dose 1]
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).
Secondary Outcome Measures
- Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine [Day 42 Post Dose 1]
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).
- Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine [Day 42 Post-vaccination]
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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
9 Months
to 10 Years
Sexes Eligible for Study:
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:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr Atul's Child Hospital | Jaipur | Rajasthan | India | 302016 |
| 2 | Government Medical College | Baroda | India | 390001 | |
| 3 | Maulana Azad Medical College | New Delhi | India | 110002 |
Sponsors and Collaborators
- Sanofi
Investigators
- Principal Investigator: Anand Dubey, M.D, Maulana Azad Medical College, New Delhi, India
- Principal Investigator: Bakul B. Javadekar, M.D., Government Medical College, Baroda, India
- Principal Investigator: Atul Shanker, Dr., Dr Atul's Child Hospital, Jaipur, Rajasthan, India
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT00441259
Other Study ID Numbers:
- H-040-004
First Posted:
Feb 28, 2007
Last Update Posted:
Aug 27, 2012
Last Verified:
Jul 1, 2012
Keywords provided by Sanofi
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled and vaccinated from 03 January 2007 to 13 January 2009 at 3 clinical centers in India. |
|---|---|
| Pre-assignment Detail | A total of 96 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. |
| Arm/Group Title | ChimeriVax™-JE | Mouse Brain Derived Vaccine |
|---|---|---|
| Arm/Group Description | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. |
| Period Title: Overall Study | ||
| STARTED | 48 | 48 |
| COMPLETED | 48 | 48 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | ChimeriVax™-JE | Mouse Brain Derived Vaccine | Total |
|---|---|---|---|
| Arm/Group Description | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. | Total of all reporting groups |
| Overall Participants | 48 | 48 | 96 |
| Age (Count of Participants) | |||
| <=18 years |
48
100%
|
48
100%
|
96
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
3.8
(2.98)
|
3.7
(2.89)
|
3.7
(2.52)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
27
56.3%
|
21
43.8%
|
48
50%
|
| Male |
21
43.8%
|
27
56.3%
|
48
50%
|
| Region of Enrollment (Number) [Number] | |||
| India |
48
100%
|
48
100%
|
96
100%
|
Outcome Measures
| Title | Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine |
|---|---|
| Description | |
| Time Frame | Day 14 up to Day 42 Post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Adverse events were assessed in all enrolled participants, intent-to-treat (safety) population. |
| Arm/Group Title | ChimeriVax™-JE | Mouse Brain Derived Vaccine |
|---|---|---|
| Arm/Group Description | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. |
| Measure Participants | 48 | 48 |
| Nasopharyngitis (All; N = 48, 48) |
2
4.2%
|
2
4.2%
|
| Otitis Media Acute (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Diarrhea Infectious (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Dysentery (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Hepatitis A (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Rash Pustular (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Tonsillitis (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Upper Respiratory Tract Infection (All; N=48, 48) |
1
2.1%
|
0
0%
|
| Varicella (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Impetigo (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Pharyngitis (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Viral Upper Respiratory Tract Infect. (All;N=48,48 |
0
0%
|
1
2.1%
|
| Diarrhea (All; N = 48, 48) |
3
6.3%
|
2
4.2%
|
| Vomiting (All; N = 48, 48) |
2
4.2%
|
1
2.1%
|
| Haematochezia (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Mucous Stools (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Constipation (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Rhinorrhea (All; N = 48, 48) |
3
6.3%
|
3
6.3%
|
| Cough (All; N = 48, 48) |
2
4.2%
|
2
4.2%
|
| Wheezing (All; N = 48, 48) |
0
0%
|
2
4.2%
|
| Pyrexia (All; N = 48, 48) |
2
4.2%
|
1
2.1%
|
| Face Edema (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Injection Site Pain (All; N = 48, 48) |
1
2.1%
|
2
4.2%
|
| Injection Site Swelling (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Malaise (All; N = 48, 48) |
1
2.1%
|
1
2.1%
|
| Pain (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Irritability (All; N = 48, 48) |
0
0%
|
2
4.2%
|
| Anorexia (All; N = 48, 48) |
2
4.2%
|
1
2.1%
|
| Anemia (All; N = 48, 48) |
2
4.2%
|
2
4.2%
|
| Eosinophilia (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Lacrimation Increased (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Laziness (All; N = 48, 48) |
2
4.2%
|
1
2.1%
|
| Erythema (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Rash (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Injury (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Eosinophil Count Increased (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Hemoglobin Decreased (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Pyrexia (≥5 to <10 yr; N = 16, 16) |
2
4.2%
|
0
0%
|
| Injection Site Pain (≥5 to <10 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Pain (≥5 to <10 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Upper Respiratory Tract Infection (≥5 to <10 yr; |
1
2.1%
|
0
0%
|
| Eosinophil Count Increased (≥5 to <10 yr; N=16, 16 |
0
0%
|
1
2.1%
|
| Otitis Media Acute (≥2 to <5 yr: N=16, 16) |
1
2.1%
|
0
0%
|
| Diarrhea Infectious (≥2 to <5 yr: N=16, 16) |
1
2.1%
|
0
0%
|
| Hepatitis A (≥2 to <5 yr: N=16, 16) |
1
2.1%
|
0
0%
|
| Rash Pustular (≥2 to <5 yr: N=16, 16) |
1
2.1%
|
0
0%
|
| Tonsillitis (≥2 to <5 yr: N=16, 16) |
1
2.1%
|
0
0%
|
| Varicella (≥2 to <5 yr: N=16, 16) |
1
2.1%
|
0
0%
|
| Vomiting (≥2 to <5 yr: N=16, 16) |
1
2.1%
|
0
0%
|
| Injection Site Pain (≥2 to <5 yr: N=16, 16) |
0
0%
|
1
2.1%
|
| Injection Site Swelling (≥2 to <5 yr: N=16, 16) |
0
0%
|
1
2.1%
|
| Pyrexia (≥2 to <5 yr: N=16, 16) |
0
0%
|
1
2.1%
|
| Rhinorrhea (≥2 to <5 yr: N=16, 16) |
1
2.1%
|
0
0%
|
| Diarrhea (≥9 mo to <2 yr; N = 16, 16) |
3
6.3%
|
2
4.2%
|
| Vomiting (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
1
2.1%
|
| Haematochezia (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Mucous Stools (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Constipation (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Cough (≥9 mo to <2 yr; N = 16, 16) |
2
4.2%
|
2
4.2%
|
| Rhinorrhea (≥9 mo to <2 yr; N = 16, 16) |
2
4.2%
|
3
6.3%
|
| Wheezing (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
2
4.2%
|
| Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16) |
2
4.2%
|
2
4.2%
|
| Dysentery (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Impetigo (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Pharyngitis (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Viral Upper Respiratory Tract Inf (≥9 mo to <2 yr) |
0
0%
|
1
2.1%
|
| Anorexia (≥9 mo to <2 yr; N = 16, 16) |
2
4.2%
|
1
2.1%
|
| Anemia (≥9 mo to <2 yr; N = 16, 16) |
2
4.2%
|
2
4.2%
|
| Eosinophilia (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Irritability (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
2
4.2%
|
| Face Edema (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Malaise (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
1
2.1%
|
| Injection Site Pain (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Laziness (≥9 mo to <2 yr; N = 16, 16) |
2
4.2%
|
1
2.1%
|
| Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Erythema (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Rash (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Injury (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Hemoglobin Decreased (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Title | Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine |
|---|---|
| Description | |
| Time Frame | Day 14 up to Day 42 Post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Adverse events were assessed all enrolled and vaccinated participants, intent-to-treat (safety) population. |
| Arm/Group Title | ChimeriVax™-JE | Mouse Brain Derived Vaccine |
|---|---|---|
| Arm/Group Description | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. |
| Measure Participants | 48 | 48 |
| Nasopharyngitis (All; N = 48, 48) |
2
4.2%
|
2
4.2%
|
| Upper Respiratory Tract Infection (All; N =48, 48) |
1
2.1%
|
0
0%
|
| Impetigo (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Pharyngitis (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Diarrhea (All; N = 48, 48) |
1
2.1%
|
2
4.2%
|
| Vomiting (All; N = 48, 48) |
1
2.1%
|
1
2.1%
|
| Hematochezia (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Mucous Stools (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Rhinorrhea (All; N = 48, 48) |
1
2.1%
|
3
6.3%
|
| Cough (All; N = 48, 48) |
2
4.2%
|
2
4.2%
|
| Wheezing (All; N = 48, 48) |
0
0%
|
2
4.2%
|
| Pyrexia (All; N = 48, 48) |
2
4.2%
|
0
0%
|
| Injection Site Pain (All; N = 48, 48) |
1
2.1%
|
2
4.2%
|
| Injection Site Swelling (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Malaise (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Pain (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Irritability (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Anorexia (All; N = 48, 48) |
1
2.1%
|
1
2.1%
|
| Anemia (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Lacrimation Increased (All; N = 48, 48) |
0
0%
|
1
2.1%
|
| Rash (All; N = 48, 48) |
1
2.1%
|
0
0%
|
| Pyrexia (≥5 to <10 yr; N = 16, 16) |
2
4.2%
|
0
0%
|
| Injection Site Pain (≥5 to <10 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Pain (≥5 to <10 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Upper Respiratory Tract Infection (≥5 to <10 yr) |
1
2.1%
|
0
0%
|
| Injection Site Pain (≥2 to <5 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Injection Site Swelling (≥2 to <5 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Diarrhea (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
2
4.2%
|
| Vomiting (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
1
2.1%
|
| Hematochezia (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Mucous Stools (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Cough (≥9 mo to <2 yr; N = 16, 16) |
2
4.2%
|
2
4.2%
|
| Rhinorrhea(≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
3
6.3%
|
| Wheezing (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
2
4.2%
|
| Nasopharyngitis (≥9 mo to <2 yr; N = 16, 16) |
2
4.2%
|
2
4.2%
|
| Impetigo (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Pharyngitis (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Anorexia (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
1
2.1%
|
| Anemia (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Irritability (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Malaise (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Injection Site Pain (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Lacrimation Increased (≥9 mo to <2 yr; N = 16, 16) |
0
0%
|
1
2.1%
|
| Rash (≥9 mo to <2 yr; N = 16, 16) |
1
2.1%
|
0
0%
|
| Title | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | ChimeriVax™-JE | Mouse Brain Derived Vaccine |
|---|---|---|
| Arm/Group Description | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. |
| Measure Participants | 33 | 35 |
| Homologous JE-CV virus PRNT (N = 33, 0) |
33
68.8%
|
NA
NaN
|
| Homologous virus Nakayama strain PRNT (N = 0, 35) |
NA
NaN
|
8
16.7%
|
| JE-CV PRNT (N = 33, 35) |
33
68.8%
|
33
68.8%
|
| Nakayama PRNT (N = 32, 35) |
8
16.7%
|
8
16.7%
|
| Indian WT virus PRNT (N = 33, 35) |
27
56.3%
|
26
54.2%
|
| Title | Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | ChimeriVax™-JE | Mouse Brain Derived Vaccine |
|---|---|---|
| Arm/Group Description | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. |
| Measure Participants | 34 | 35 |
| Homologous JE-CV virus PRNT (N = 34, 0) |
313.5
|
NA
|
| Homologous virus Nakayama strain PRNT (N = 0, 35) |
NA
|
8.0
|
| JE-CV PRNT (N = 34, 35) |
313.5
|
49.7
|
| Nakayama PRNT (N = 33, 35) |
7.8
|
8.0
|
| Indian WT virus PRNT (N = 34, 35) |
60.1
|
17.1
|
| Title | Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | ChimeriVax™-JE | Mouse Brain Derived Vaccine |
|---|---|---|
| Arm/Group Description | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. |
| Measure Participants | 34 | 35 |
| Homologous JE-CV virus PRNT (N = 33, 0) |
33
68.8%
|
NA
NaN
|
| Homologous virus Nakayama strain PRNT (N=0,35) |
NA
NaN
|
8
16.7%
|
| JE-CV Virus (All; N = 33, 35) |
33
68.8%
|
33
68.8%
|
| Nakayama Strain (All; N = 32, 35) |
8
16.7%
|
8
16.7%
|
| Wild Type Virus (All; N = 33, 35) |
27
56.3%
|
26
54.2%
|
| JE-CV Virus (≥5 to <10 yr; N = 12, 13) |
12
25%
|
12
25%
|
| JE Virus Nakayama strain (≥5 to <10 yr; N =12, 13) |
6
12.5%
|
0
0%
|
| Wild Type Virus (≥5 to <10 yr; N = 12, 13) |
12
25%
|
11
22.9%
|
| JE-CV Virus (≥2 to <5 yr; N = 8, 9) |
8
16.7%
|
9
18.8%
|
| JE Virus Nakayama strain (≥2 to <5 yr; N = 9, 9) |
1
2.1%
|
6
12.5%
|
| Wild Type Virus (≥2 to <5 yr; N = 8, 9) |
2
4.2%
|
6
12.5%
|
| JE-CV Virus (≥9 mo to <2 yr; N = 13, 13) |
13
27.1%
|
12
25%
|
| JE Virus Nakayama (≥9 mo to <2 yr; N = 11, 13) |
1
2.1%
|
2
4.2%
|
| Wild Type Virus (≥9 mo to <2 yr; N=13, 13) |
13
27.1%
|
9
18.8%
|
| Title | Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | ChimeriVax™-JE | Mouse Brain Derived Vaccine |
|---|---|---|
| Arm/Group Description | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. |
| Measure Participants | 34 | 35 |
| JE-CV Virus (All; N = 34, 35) |
313.5
|
49.7
|
| JE Nakayama Strain (All; N = 33, 35) |
7.8
|
8.0
|
| Wild Type Virus (All; N = 34, 35) |
60.1
|
17.1
|
| JE-CV Virus (≥5 to <10 yr; N = 12, 13) |
226.3
|
34.1
|
| JE Virus Nakayama Strain (≥5 to <10 yr; N =12, 13) |
13.3
|
5.0
|
| Wild Type virus (≥5 to <10 yr; N = 12, 13) |
100.8
|
17.0
|
| JE-CV Virus (≥2 to <5 yr; N = 9, 9) |
254.0
|
74.1
|
| JE Virus Nakayama Strain (≥2 to <5 yr; N = 9, 9) |
6.3
|
27.2
|
| Wild Type Virus (≥2 to <5 yr; N = 9, 9) |
9.3
|
17.1
|
| JE-CV Virus (≥9 mo to <2 yr; N = 13, 13) |
490.2
|
55.1
|
| JE Virus Nakayama (≥9 mo to <2 yr; N = 12, 13) |
5.3
|
5.6
|
| Wild Type Virus (≥9 mo to <2 yr; N = 13, 13) |
136.3
|
17.0
|
Adverse Events
| Time Frame | Adverse events were assessed from Day 14 to Day 42 (up to 28 days after completion of the course of vaccination). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | ChimeriVax™-JE | Mouse Brain Derived Vaccine | ||
| Arm/Group Description | Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. | ||
All Cause Mortality |
||||
| ChimeriVax™-JE | Mouse Brain Derived Vaccine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| ChimeriVax™-JE | Mouse Brain Derived Vaccine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/48 (0%) | 0/48 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| ChimeriVax™-JE | Mouse Brain Derived Vaccine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/48 (12.5%) | 5/48 (10.4%) | ||
| Gastrointestinal disorders | ||||
| Diarrhea | 3/48 (6.3%) | 3 | 2/48 (4.2%) | 5 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Rhinorrhea | 3/48 (6.3%) | 4 | 3/48 (6.3%) | 7 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Sanofi Pasteur Inc. |
| Phone | |
| RegistryContactUs@sanofipasteur.com |
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT00441259
Other Study ID Numbers:
- H-040-004
First Posted:
Feb 28, 2007
Last Update Posted:
Aug 27, 2012
Last Verified:
Jul 1, 2012