Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00621764
Collaborator
(none)
300
3
4
62
100
1.6
Study Details
Study Description
Brief Summary
Safety:
To describe the safety profiles following vaccination.
Immunogenicity:
To describe the immune response after a single dose of vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a randomized, cross-over, open, active controlled, multi-center trial in toddlers and children in Thailand. Stepwise enrollment of children in 2 age cohorts. Subjects will be followed for 5 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
300 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Study Start Date
:
Mar 1, 2008
Actual Primary Completion Date
:
Dec 1, 2009
Actual Study Completion Date
:
May 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JE-CV/Hepatitis A (Group 1) Participants aged 2 to 5 years at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28) |
Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)
Other Names:
|
| Experimental: Hepatitis A/JE-CV (Group 2) Participants aged 2 to 5 years at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28) |
Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
Other Names:
|
| Experimental: JE-CV/Hepatitis A (Group 3) Participants aged 12 to 24 months at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28) |
Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)
Other Names:
|
| Experimental: Hepatitis A/JE-CV (Group 4) Participants aged 12 to 24 months at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28) |
Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection [Day 0 up to Day 14 post-vaccination]
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities.
- Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection [Day 0 up to Day 14 post-vaccination]
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities.
Secondary Outcome Measures
- Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination [Day 0 (pre-vaccination) and Day 28 after final vaccination]
JE virus neutralizing antibody measurement was assessed by plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer < 10 (1/dil) and post-vaccination titer ≥ 10 (1/dil), or participants with pre-vaccination titer ≥ 10 (1/dil) and 4-fold increase from pre- to post-vaccination.
- Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination [Day 0 (pre-vaccination) and Day 28 after final vaccination]
JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Other Outcome Measures
- Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination [Day 0 (pre-vaccination) up to 5 years after final vaccination]
Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.
- Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine [Day 0 (pre-vaccination) up to 5 years after final vaccination]
Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Months
to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness.
-
Completion of vaccinations according to the national immunization schedule
-
Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
-
Previous receipt of two doses of a mouse-brain-derived JE vaccine at 12 to 15 months of age according to the national immunization schedule and aged 2 to 5 years on the day of inclusion.
-
Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.
Exclusion Criteria:
-
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
-
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
-
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
-
Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
-
Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
-
Receipt of hepatitis A vaccine.
-
History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
-
Administration of any anti-viral within 2 months preceding the screening visit.
-
History of central nervous system disorder or disease.
-
Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
-
Planned participation in another clinical trial during the present trial period.
-
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
-
Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
-
Personal human immunodeficiency virus, hepatitis B or hepatitis C seropositivity in the blood sample taken at screening.
-
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination.
-
Previous vaccination against flavivirus disease at any time before the trial other than a mouse-brain-derived JE vaccine given in a two-dose regimen at 12 to 15 months of age in accordance with the national immunization schedule.
-
Febrile illness or any acute illness/infection on the day of vaccination, according to investigator judgment
-
History of seizures.
-
Previous vaccination against flavivirus disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bangkok | Thailand | 10330 | ||
| 2 | Bangkok | Thailand | 10400 | ||
| 3 | Bangkok | Thailand | 10700 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur SA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00621764
Other Study ID Numbers:
- JEC01
First Posted:
Feb 22, 2008
Last Update Posted:
Oct 2, 2014
Last Verified:
Sep 1, 2014
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study participants were enrolled from 02 March 2008 to 06 January 2009 at 3 clinic centers in Thailand. |
|---|---|
| Pre-assignment Detail | A total of 300 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study. |
| Arm/Group Title | JE-CV/Hepatitis A (Group 1) | Hepatitis A/JE-CV (Group 2) | JE-CV/Hepatitis A (Group 3) | Hepatitis A/JE-CV (Group 4) |
|---|---|---|---|---|
| Arm/Group Description | Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart |
| Period Title: Overall Study | ||||
| STARTED | 50 | 50 | 101 | 99 |
| COMPLETED | 50 | 50 | 101 | 98 |
| NOT COMPLETED | 0 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | JE CV/Hepatitis A (Group 1) | Hepatitis A/JE CV (Group 2) | JE CV/Hepatitis A (Group 3) | Hepatitis A/JE CV (Group 4) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart | Total of all reporting groups |
| Overall Participants | 50 | 50 | 101 | 99 | 300 |
| Age (Count of Participants) | |||||
| <=18 years |
50
100%
|
50
100%
|
101
100%
|
99
100%
|
300
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
2.4
(0.5)
|
2.5
(0.6)
|
1.4
(0.2)
|
1.3
(0.2)
|
1.7
(0.6)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
17
34%
|
35
70%
|
57
56.4%
|
57
57.6%
|
166
55.3%
|
| Male |
33
66%
|
15
30%
|
44
43.6%
|
42
42.4%
|
134
44.7%
|
| Region of Enrollment (Number) [Number] | |||||
| Thailand |
50
100%
|
50
100%
|
101
100%
|
99
100%
|
300
100%
|
Outcome Measures
| Title | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection |
|---|---|
| Description | 12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities. |
| Time Frame | Day 0 up to Day 14 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine. |
| Arm/Group Title | JE-CV/Hepatitis A (Group 1) | Hepatitis A/JE-CV (Group 2) | JE-CV/Hepatitis A (Group 3) | Hepatitis A/JE-CV (Group 4) |
|---|---|---|---|---|
| Arm/Group Description | Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart |
| Measure Participants | 50 | 50 | 101 | 99 |
| Injection site Pain (N=50,50,0,0) |
15
30%
|
13
26%
|
NA
NaN
|
NA
NaN
|
| Grade 3 Injection site Pain (N=50,50,0,0) |
0
0%
|
0
0%
|
NA
NaN
|
NA
NaN
|
| Injection site Tenderness (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
43
42.6%
|
19
19.2%
|
| Grade 3 Injection site Tenderness (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
0
0%
|
0
0%
|
| Injection site Erythema (N=50,50,101,99) |
7
14%
|
9
18%
|
23
22.8%
|
16
16.2%
|
| Grade 3 Injection site Erythema (N=50,50,101,99) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Injection site Swelling (N=50,50,101,99) |
4
8%
|
5
10%
|
6
5.9%
|
8
8.1%
|
| Grade 3 Swelling (N=50,50,101,99) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Fever (N=50,50,101,99) |
8
16%
|
8
16%
|
14
13.9%
|
18
18.2%
|
| Grade 3 Fever (N=50,50,101,99) |
1
2%
|
0
0%
|
0
0%
|
0
0%
|
| Headache (N=50,50,0,0) |
7
14%
|
7
14%
|
NA
NaN
|
NA
NaN
|
| Grade 3 Headache (N=50,50,0,0) |
0
0%
|
0
0%
|
NA
NaN
|
NA
NaN
|
| Malaise (N=50,50,0,0) |
15
30%
|
13
26%
|
NA
NaN
|
NA
NaN
|
| Grade 3 Malaise (N=50,50,0,0) |
0
0%
|
0
0%
|
NA
NaN
|
NA
NaN
|
| Myalgia (N=50,50,0,0) |
14
28%
|
8
16%
|
NA
NaN
|
NA
NaN
|
| Grade 3 Myalgia (N=50,50,0,0) |
0
0%
|
0
0%
|
NA
NaN
|
NA
NaN
|
| Vomiting (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
21
20.8%
|
21
21.2%
|
| Grade 3 Vomiting (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
1
1%
|
0
0%
|
| Crying abnormal (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
24
23.8%
|
20
20.2%
|
| Grade 3 Crying abnormal (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
0
0%
|
0
0%
|
| Drowsiness (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
22
21.8%
|
13
13.1%
|
| Grade 3 Drowsiness (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
0
0%
|
0
0%
|
| Appetite lost (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
28
27.7%
|
32
32.3%
|
| Grade 3 Appetite lost (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
0
0%
|
2
2%
|
| Irritability (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
32
31.7%
|
24
24.2%
|
| Grade 3 Irritability (N=0,0,101,99) |
NA
NaN
|
NA
NaN
|
0
0%
|
0
0%
|
| Title | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection |
|---|---|
| Description | 12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities. |
| Time Frame | Day 0 up to Day 14 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine. A participant in Group 1 was given JE-CV vaccine as the second vaccination in error; and counted for Group 2 for the safety outcome for the second injection. |
| Arm/Group Title | JE-CV/Hepatitis A (Group 1) | Hepatitis A/JE-CV (Group 2) | JE-CV/Hepatitis A (Group 3) | Hepatitis A/JE-CV (Group 4) |
|---|---|---|---|---|
| Arm/Group Description | Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart |
| Measure Participants | 48 | 51 | 101 | 98 |
| Injection site Pain (N=48,51,0,0) |
15
30%
|
9
18%
|
NA
NaN
|
NA
NaN
|
| Grade 3 Injection site Pain (N=48,51,0,0) |
0
0%
|
0
0%
|
NA
NaN
|
NA
NaN
|
| Injection site Tenderness (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
35
34.7%
|
20
20.2%
|
| Grade 3 Injection site Tenderness (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
1
1%
|
0
0%
|
| Injection site Erythema (N=48,51,100,98) |
8
16%
|
7
14%
|
23
22.8%
|
22
22.2%
|
| Grade 3 Injection site Erythema (N=48,51,100,98) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Injection site Swelling (N=48,51,100,98) |
8
16%
|
4
8%
|
6
5.9%
|
11
11.1%
|
| Grade 3 Swelling (N=48,51,100,98) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Fever (N=48,51,100,98) |
5
10%
|
14
28%
|
23
22.8%
|
28
28.3%
|
| Grade 3 Fever (N=48,51,100,98) |
1
2%
|
0
0%
|
1
1%
|
2
2%
|
| Headache (N=48,51,0,0) |
7
14%
|
14
28%
|
NA
NaN
|
NA
NaN
|
| Grade 3 Headache (N=48,51,0,0) |
0
0%
|
0
0%
|
NA
NaN
|
NA
NaN
|
| Malaise (N=48,51,0,0) |
13
26%
|
18
36%
|
NA
NaN
|
NA
NaN
|
| Grade 3 Malaise (N=48,51,0,0) |
0
0%
|
0
0%
|
NA
NaN
|
NA
NaN
|
| Myalgia (N=48,51,0,0) |
7
14%
|
10
20%
|
NA
NaN
|
NA
NaN
|
| Grade 3 Myalgia (N=48,51,0,0) |
0
0%
|
0
0%
|
NA
NaN
|
NA
NaN
|
| Vomiting (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
23
22.8%
|
19
19.2%
|
| Grade 3 Vomiting (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
1
1%
|
1
1%
|
| Crying abnormal (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
19
18.8%
|
21
21.2%
|
| Grade 3 Crying abnormal (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
2
2%
|
0
0%
|
| Drowsiness (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
17
16.8%
|
14
14.1%
|
| Grade 3 Drowsiness (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
0
0%
|
0
0%
|
| Appetite lost (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
26
25.7%
|
24
24.2%
|
| Grade 3 Appetite lost (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
2
2%
|
1
1%
|
| Irritability (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
22
21.8%
|
24
24.2%
|
| Grade 3 Irritability (N=0,0,100,98) |
NA
NaN
|
NA
NaN
|
1
1%
|
0
0%
|
| Title | Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination |
|---|---|
| Description | JE virus neutralizing antibody measurement was assessed by plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer < 10 (1/dil) and post-vaccination titer ≥ 10 (1/dil), or participants with pre-vaccination titer ≥ 10 (1/dil) and 4-fold increase from pre- to post-vaccination. |
| Time Frame | Day 0 (pre-vaccination) and Day 28 after final vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroconversion to the JE-CV vaccine antigens was assessed in the Per-Protocol Analysis Set. |
| Arm/Group Title | JE-CV/Hepatitis A (Group 1) | Hepatitis A/JE-CV (Group 2) | JE-CV/Hepatitis A (Group 3) | Hepatitis A/JE-CV (Group 4) |
|---|---|---|---|---|
| Arm/Group Description | Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart. |
| Measure Participants | 49 | 48 | 87 | 95 |
| Homologous virus (N=49,48,83,88) |
89.8
179.6%
|
95.8
191.6%
|
100.0
99%
|
93.2
94.1%
|
| Genotype I (N=49,48,81,91) |
83.7
167.4%
|
93.8
187.6%
|
98.8
97.8%
|
95.6
96.6%
|
| Genotype II (N=49,48,81,91) |
83.7
167.4%
|
93.8
187.6%
|
96.3
95.3%
|
95.6
96.6%
|
| Genotype III (N=49,48,81,93) |
87.8
175.6%
|
91.7
183.4%
|
100.0
99%
|
94.6
95.6%
|
| Genotype IV (N=49,48,81,90) |
89.8
179.6%
|
91.7
183.4%
|
74.1
73.4%
|
65.6
66.3%
|
| Title | Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination |
|---|---|
| Description | JE virus neutralizing antibody measurement was assessed by the PRNT50 assay. |
| Time Frame | Day 0 (pre-vaccination) and Day 28 after final vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric mean titers against the JE-CV vaccine antigens were assessed in the Per-Protocol Analysis Set. |
| Arm/Group Title | JE-CV/Hepatitis A (Group 1) | Hepatitis A/JE-CV (Group 2) | JE-CV/Hepatitis A (Group 3) | Hepatitis A/JE-CV (Group 4) |
|---|---|---|---|---|
| Arm/Group Description | Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart |
| Measure Participants | 49 | 48 | 87 | 95 |
| Homologous virus (pre-vaccination; N=49,48,86,90) |
49.5
|
40.6
|
5.78
|
5.08
|
| Homologous virus (post-vaccination; N=49,48,84,93) |
1957
|
3568
|
500
|
167
|
| Genotype I (pre-vaccination; N=49,48,83,91) |
55.2
|
55.3
|
5.00
|
5.00
|
| Genotype I (post-vaccination; N=49,48,82,94) |
1016
|
1988
|
170
|
155
|
| Genotype II (pre-vaccination; N=49,48,83,91) |
46.5
|
34.2
|
5.00
|
5.00
|
| Genotype II (post-vaccination; N=49,48,82,94) |
921
|
1566
|
157
|
121
|
| Genotype III (pre-vaccination; N=49,48,83,93) |
39.2
|
40.6
|
5.00
|
5.00
|
| Genotype III (post-vaccination; N=49,48,82,94) |
1107
|
2089
|
189
|
98.2
|
| Genotype IV (pre-vaccination; N=49,48,83,90) |
25.2
|
20.0
|
5.00
|
5.00
|
| Genotype IV (post-vaccination; N=49,48,82,94) |
604
|
829
|
25.3
|
17.0
|
| Title | Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination |
|---|---|
| Description | Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay. |
| Time Frame | Day 0 (pre-vaccination) up to 5 years after final vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Persistence of seroprotection to JE-CV antigens was assessed in the Full Analysis Set. |
| Arm/Group Title | JE-CV/Hepatitis A (Group 1) | Hepatitis A/JE-CV (Group 2) | JE-CV/Hepatitis A (Group 3) | Hepatitis A/JE-CV (Group 4) |
|---|---|---|---|---|
| Arm/Group Description | Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart |
| Measure Participants | 50 | 50 | 101 | 99 |
| Homologous virus (pre-vaccination; N=50,50,100,94) |
45
90%
|
41
82%
|
15
14.9%
|
2
2%
|
| Homologous virus (post-vaccination; N=49,50,98,96) |
49
98%
|
50
100%
|
98
97%
|
89
89.9%
|
| Homologous virus (post-6 months; N=48,49,99,98) |
48
96%
|
49
98%
|
91
90.1%
|
80
80.8%
|
| Homologous virus (post-1 year; N=48,45,91,89) |
46
92%
|
44
88%
|
81
80.2%
|
71
71.7%
|
| Homologous virus (post-2 years; N=43,41,85,79) |
41
82%
|
41
82%
|
74
73.3%
|
64
64.6%
|
| Homologous virus (post-3 years; N=40,38,68,56) |
40
80%
|
38
76%
|
66
65.3%
|
52
52.5%
|
| Homologous virus (post-4 years; N=41,36,63,56) |
41
82%
|
36
72%
|
63
62.4%
|
54
54.5%
|
| Homologous virus (post-5 years; N=40,38,60,50) |
40
80%
|
38
76%
|
55
54.5%
|
44
44.4%
|
| Genotype I (pre-vaccination; N=50,50,97,95) |
40
80%
|
41
82%
|
8
7.9%
|
3
3%
|
| Genotype I (post-vaccination; N=49,50,96,97) |
49
98%
|
50
100%
|
95
94.1%
|
93
93.9%
|
| Genotype I (post-6 months; N=47,48,99,98) |
47
94%
|
48
96%
|
95
94.1%
|
86
86.9%
|
| Genotype II (pre-vaccination; N=49,50,97,95) |
39
78%
|
39
78%
|
9
8.9%
|
2
2%
|
| Genotype II (post-vaccination; N=49,50,96,97) |
49
98%
|
50
100%
|
93
92.1%
|
93
93.9%
|
| Genotype II (post-6 months; N=47,48,99,98) |
47
94%
|
48
96%
|
90
89.1%
|
80
80.8%
|
| Genotype III (pre-vaccination; N=50,50,97,97) |
41
82%
|
38
76%
|
5
5%
|
1
1%
|
| Genotype III (post-vaccination; N=49,50,96,97) |
49
98%
|
50
100%
|
96
95%
|
92
92.9%
|
| Genotype III (post-6 months; N=48,48,99,98) |
48
96%
|
48
96%
|
73
72.3%
|
62
62.6%
|
| Genotype IV (pre-vaccination; N=49,50,97,94) |
39
78%
|
32
64%
|
5
5%
|
0
0%
|
| Genotype IV (post-vaccination; N=49,50,96,97) |
48
96%
|
50
100%
|
73
72.3%
|
65
65.7%
|
| Genotype IV (post-6 months; N=47,48,99,98) |
47
94%
|
48
96%
|
68
67.3%
|
46
46.5%
|
| Title | Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine |
|---|---|
| Description | Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay. |
| Time Frame | Day 0 (pre-vaccination) up to 5 years after final vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric Mean Titers Against JE Antibodies were assessed in the Full Analysis Set. |
| Arm/Group Title | JE-CV/Hepatitis A (Group 1) | Hepatitis A/JE-CV (Group 2) | JE-CV/Hepatitis A (Group 3) | Hepatitis A/JE-CV (Group 4) |
|---|---|---|---|---|
| Arm/Group Description | Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart |
| Measure Participants | 50 | 50 | 101 | 99 |
| Homologous virus (pre-vaccination; N=50,50,100,94) |
48.6
|
41.1
|
6.11
|
5.15
|
| Homologous virus (post-vaccination; N=49,50,98,96) |
1956.7
|
3722.2
|
517.6
|
167.1
|
| Homologous virus (post-6 months; N=48,49,99,98) |
892.1
|
1244.3
|
96.6
|
49.8
|
| Homologous virus (post-1 year; N=48,45,91,89) |
339
|
621
|
78.8
|
49.0
|
| Homologous virus (post-2 years; N=43,41,85,79) |
414
|
662
|
94.2
|
67.1
|
| Homologous virus (post-3 years; N=40,38,68,56) |
422
|
505
|
146
|
90.5
|
| Homologous virus (post-4 years; N=41,36,63,56) |
360
|
559
|
137
|
110
|
| Homologous virus (post-5 years; N=40,38,60,50) |
222
|
287
|
68.8
|
58.2
|
| Genotype I (pre-vaccination; N=50,50,97,95) |
54.8
|
55.3
|
5.62
|
5.18
|
| Genotype I (post-vaccination; N=49,50,96,97) |
1015.8
|
2116.7
|
186.8
|
163.1
|
| Genotype I (6-months; N=47,48,99,98) |
863.5
|
981.0
|
81.4
|
52.4
|
| Genotype II (pre-vaccination; N=49,50,97,95) |
46.5
|
33.3
|
5.75
|
5.20
|
| Genotype II (post-vaccination; N=49,50,96,97) |
920.6
|
1763.4
|
163.2
|
126.8
|
| Genotype II (post-6 months; N=47,48,99,98) |
581.2
|
714.4
|
72.3
|
42.4
|
| Genotype III (pre-vaccination; N=50,50,97,97) |
37.6
|
41.1
|
5.39
|
5.08
|
| Genotype III (post-vaccination; N=49,50,96,97) |
1107.1
|
2210.4
|
200.2
|
102.1
|
| Genotype III (post-6 months; N=48,48,99,98) |
513.1
|
645.7
|
31.1
|
20.2
|
| Genotype IV (pre-vaccination; N=49,50,97,94) |
25.2
|
19.7
|
5.31
|
5.00
|
| Genotype IV (post-vaccination; N=49,50,96,97) |
604.0
|
874.0
|
28.5
|
18.1
|
| Genotype IV (post-6 months; N=47,48,99,98) |
279.4
|
363.4
|
21.0
|
12.6
|
Adverse Events
| Time Frame | Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | JE CV/Hepatitis A (Group 1) | Hepatitis A/JE CV (Group 2) | JE CV/Hepatitis A (Group 3) | Hepatitis A/JE CV (Group 4) | ||||
| Arm/Group Description | Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart | Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart | ||||
All Cause Mortality |
||||||||
| JE CV/Hepatitis A (Group 1) | Hepatitis A/JE CV (Group 2) | JE CV/Hepatitis A (Group 3) | Hepatitis A/JE CV (Group 4) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| JE CV/Hepatitis A (Group 1) | Hepatitis A/JE CV (Group 2) | JE CV/Hepatitis A (Group 3) | Hepatitis A/JE CV (Group 4) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/50 (6%) | 3/50 (6%) | 11/101 (10.9%) | 10/99 (10.1%) | ||||
| Infections and infestations | ||||||||
| Bronchiolitis | 0/50 (0%) | 0 | 0/50 (0%) | 0 | 0/101 (0%) | 0 | 2/99 (2%) | 2 |
| Bronchitis | 1/50 (2%) | 1 | 0/50 (0%) | 0 | 1/101 (1%) | 1 | 0/99 (0%) | 0 |
| Gastroenteritis | 0/50 (0%) | 0 | 1/50 (2%) | 1 | 4/101 (4%) | 4 | 0/99 (0%) | 0 |
| Gastroenteritis rotavirus | 1/50 (2%) | 1 | 0/50 (0%) | 0 | 0/101 (0%) | 0 | 1/99 (1%) | 1 |
| Herpangina | 0/50 (0%) | 0 | 0/50 (0%) | 0 | 0/101 (0%) | 0 | 1/99 (1%) | 1 |
| Influenza | 0/50 (0%) | 0 | 0/50 (0%) | 0 | 0/101 (0%) | 0 | 1/99 (1%) | 1 |
| Pharyngitis | 0/50 (0%) | 0 | 0/50 (0%) | 0 | 1/101 (1%) | 1 | 1/99 (1%) | 1 |
| Pneumonia | 0/50 (0%) | 0 | 1/50 (2%) | 1 | 2/101 (2%) | 2 | 1/99 (1%) | 1 |
| Pneumonia viral | 1/50 (2%) | 1 | 0/50 (0%) | 0 | 1/101 (1%) | 1 | 1/99 (1%) | 1 |
| Upper respiratory tract infection | 0/50 (0%) | 0 | 0/50 (0%) | 0 | 1/101 (1%) | 1 | 0/99 (0%) | 0 |
| Viral infection | 0/50 (0%) | 0 | 0/50 (0%) | 0 | 1/101 (1%) | 1 | 0/99 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Wound | 0/50 (0%) | 0 | 1/50 (2%) | 1 | 1/101 (1%) | 1 | 0/99 (0%) | 0 |
| Nervous system disorders | ||||||||
| Febrile convulsion | 0/50 (0%) | 0 | 1/50 (2%) | 1 | 1/101 (1%) | 1 | 3/99 (3%) | 4 |
Other (Not Including Serious) Adverse Events |
||||||||
| JE CV/Hepatitis A (Group 1) | Hepatitis A/JE CV (Group 2) | JE CV/Hepatitis A (Group 3) | Hepatitis A/JE CV (Group 4) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/50 (30%) | 18/50 (36%) | 43/101 (42.6%) | 35/99 (35.4%) | ||||
| Gastrointestinal disorders | ||||||||
| Vomiting | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 23/100 (23%) | 23 | 21/99 (21.2%) | 21 |
| General disorders | ||||||||
| Pyrexia | 3/50 (6%) | 3 | 0/50 (0%) | 0 | 0/101 (0%) | 0 | 0/99 (0%) | 0 |
| Injection-site pain | 15/48 (31.3%) | 15 | 13/50 (26%) | 13 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Injection-site tenderness | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 43/101 (42.6%) | 43 | 20/98 (20.4%) | 20 |
| Injection-site erythema | 8/48 (16.7%) | 8 | 9/50 (18%) | 9 | 23/100 (23%) | 23 | 22/98 (22.4%) | 22 |
| Injection-site swelling | 8/48 (16.7%) | 8 | 5/50 (10%) | 5 | 6/100 (6%) | 6 | 11/98 (11.2%) | 11 |
| Fever | 8/50 (16%) | 8 | 14/50 (28%) | 14 | 23/100 (23%) | 23 | 28/98 (28.6%) | 28 |
| Malaise | 15/50 (30%) | 15 | 18/50 (36%) | 18 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Infections and infestations | ||||||||
| Bronchitis | 3/48 (6.3%) | 3 | 3/50 (6%) | 3 | 0/101 (0%) | 0 | 0/99 (0%) | 0 |
| Nasopharyngitis | 1/50 (2%) | 1 | 5/50 (10%) | 5 | 5/101 (5%) | 5 | 11/99 (11.1%) | 12 |
| Upper respiratory tract infection | 8/50 (16%) | 9 | 8/50 (16%) | 8 | 35/101 (34.7%) | 35 | 35/99 (35.4%) | 39 |
| Metabolism and nutrition disorders | ||||||||
| Appetite lost | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 28/101 (27.7%) | 28 | 32/99 (32.3%) | 32 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Myalgia | 14/50 (28%) | 14 | 10/50 (20%) | 10 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Nervous system disorders | ||||||||
| Headache | 7/48 (14.6%) | 7 | 14/50 (28%) | 14 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Drowsiness | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 22/101 (21.8%) | 22 | 14/98 (14.3%) | 14 |
| Psychiatric disorders | ||||||||
| Crying abnormal | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 24/101 (23.8%) | 24 | 21/98 (21.4%) | 21 |
| Irritability | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 32/101 (31.7%) | 32 | 24/98 (24.5%) | 24 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 4/50 (8%) | 4 | 1/50 (2%) | 1 | 0/101 (0%) | 0 | 0/99 (0%) | 0 |
| Rhinorrhoea | 3/50 (6%) | 3 | 1/50 (2%) | 1 | 13/101 (12.9%) | 16 | 11/99 (11.1%) | 12 |
| Skin and subcutaneous tissue disorders | ||||||||
| Heat rash | 3/48 (6.3%) | 4 | 0/50 (0%) | 0 | 0/101 (0%) | 0 | 0/99 (0%) | 0 |
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 Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00621764
Other Study ID Numbers:
- JEC01
First Posted:
Feb 22, 2008
Last Update Posted:
Oct 2, 2014
Last Verified:
Sep 1, 2014