Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00735644
Collaborator
(none)
1,200
8
5
12
150
12.5
Study Details
Study Description
Brief Summary
This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months.
Primary objective:
To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur.
Secondary objective:
To describe the safety of vaccination in all subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a Phase III trial in toddlers in Thailand and the Philippines.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
Study Start Date
:
Aug 1, 2008
Actual Primary Completion Date
:
May 1, 2009
Actual Study Completion Date
:
Aug 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JE-CV GPO MBP (Lot 1) Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1. |
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
Other Names:
|
| Experimental: JE-CV GPO MBP (Lot 2) Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 2. |
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
Other Names:
|
| Experimental: JE-CV GPO MBP (Lot 3) Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 3. |
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
Other Names:
|
| Active Comparator: JE-CV WRAIR (Group 4) Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) |
Biological: Japanese encephalitis vaccine (Acambis)
0.5 mL, Subcutaneous
|
| Sham Comparator: Hepatitis A (Group 5) Participants 12 to 18 months of age randomized to receive Hepatitis A vaccine |
Biological: Hepatitis A vaccine
0.5 mL, Intramuscular
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots [Day 0 (pre-vaccination) and Day 28 post-vaccination]
Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% 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.
Secondary Outcome Measures
- Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV [Day 0 (pre-vaccination) and Day 28 post-vaccination]
Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.
- Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV [Day 0 (pre-vaccination) and Day 28 post-vaccination]
Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).
- Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine [Day 0 (pre-vaccination) and Day 28 post-vaccination]
Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. [Day 0 up to Day 14 post-vaccination]
Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >39.5˚C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal, >3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.
Other Outcome Measures
- Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. [Day 0 (pre-vaccination)]
Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain <10 l/dil and anti-dengue against the 4 serotypes <10 l/dilution.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Months
to 18 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria :
-
Aged 12 to 18 months on the day of inclusion.
-
In good general health, without significant medical history.
-
Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
-
Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
-
Completion of vaccinations according to the national immunization schedule.
Exclusion Criteria :
-
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
-
Planned participation in another clinical trial during the present trial period.
-
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 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.
-
Administration of any anti-viral within 2 months preceding V01.
-
History of central nervous system disorder or disease, including seizures.
-
Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
-
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 seropositivity in the blood sample taken at screening.
-
Receipt of any JE vaccine or hepatitis A vaccine.
-
Previous vaccination against flavivirus disease.
-
History of flavivirus infection (confirmed either clinically, serologically or microbiologically)
-
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
-
Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alabang | Philippines | |||
| 2 | Bayanan | Philippines | |||
| 3 | Buli | Philippines | |||
| 4 | Cupang | Philippines | |||
| 5 | Sucat | Philippines | |||
| 6 | Bangkok | Thailand | 10330 | ||
| 7 | Bangkok | Thailand | 10400 | ||
| 8 | Khon Kaen | Thailand | 40002 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Monitor, Sanofi Pasteur Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00735644
Other Study ID Numbers:
- JEC02
First Posted:
Aug 15, 2008
Last Update Posted:
Apr 21, 2015
Last Verified:
Apr 1, 2015
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 August 2008 through 27 March 2009 at 3 clinic sites in Thailand and 5 clinic sites in the Philippines. |
|---|---|
| Pre-assignment Detail | A total of 1200 participants who met all of the inclusion and none of the exclusion criteria were randomized, 1199 were vaccinated in this study. |
| Arm/Group Title | JE-CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A |
|---|---|---|---|---|---|
| Arm/Group Description | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1. | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 | Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3 | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) | Participants 12 to 18 months of age received the Hepatitis A vaccine |
| Period Title: Overall Study | |||||
| STARTED | 303 | 300 | 296 | 199 | 102 |
| COMPLETED | 303 | 298 | 295 | 198 | 102 |
| NOT COMPLETED | 0 | 2 | 1 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | JE CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3 | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) | Participants 12 to 18 months of age received Hepatitis A vaccine | Total of all reporting groups |
| Overall Participants | 303 | 299 | 296 | 199 | 102 | 1199 |
| Age (Count of Participants) | ||||||
| <=18 years |
303
100%
|
299
100%
|
296
100%
|
199
100%
|
102
100%
|
1199
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (Months) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [Months] |
14.3
(1.91)
|
14.5
(1.84)
|
14.4
(1.88)
|
14.3
(1.81)
|
14.3
(1.93)
|
14.4
(1.87)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
155
51.2%
|
138
46.2%
|
143
48.3%
|
94
47.2%
|
45
44.1%
|
575
48%
|
| Male |
148
48.8%
|
161
53.8%
|
153
51.7%
|
105
52.8%
|
57
55.9%
|
624
52%
|
| Region of Enrollment (Number) [Number] | ||||||
| Thailand |
123
40.6%
|
122
40.8%
|
121
40.9%
|
82
41.2%
|
42
41.2%
|
490
40.9%
|
| Philippines |
180
59.4%
|
177
59.2%
|
175
59.1%
|
117
58.8%
|
60
58.8%
|
709
59.1%
|
Outcome Measures
| Title | Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots |
|---|---|
| Description | Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% 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 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroconversion to the JE CV vaccine antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set. |
| Arm/Group Title | JE CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A |
|---|---|---|---|---|---|
| Arm/Group Description | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3 | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) | Participants 12 to 18 months of age received Hepatitis A vaccine |
| Measure Participants | 288 | 292 | 286 | 193 | 97 |
| JE CV Day 0 (≥10 1/dil; N=288, 290, 285, 192, 0) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
NA
NaN
|
| JE CV Day 28 (≥10 1/dil; N=288, 284, 283, 192, 0) |
282
93.1%
|
262
87.6%
|
267
90.2%
|
185
93%
|
NA
NaN
|
| Title | Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV |
|---|---|
| Description | Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay. |
| Time Frame | Day 0 (pre-vaccination) and Day 28 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric mean titers against the JE CV antigens were assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set. |
| Arm/Group Title | JE CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A |
|---|---|---|---|---|---|
| Arm/Group Description | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3 | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) | Participants 12 to 18 months of age received Hepatitis A vaccine |
| Measure Participants | 288 | 292 | 286 | 193 | 0 |
| Anti JE-CV Day 0 (N=288, 290, 285, 192, 0) |
5.17
|
5.08
|
5.19
|
5.09
|
|
| Anti JE CV Day 28 (N=288, 284, 283, 192, 0) |
212
|
167
|
188
|
212
|
| Title | Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV |
|---|---|
| Description | Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil). |
| Time Frame | Day 0 (pre-vaccination) and Day 28 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroprotection against JE CV antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set. |
| Arm/Group Title | JE-CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A |
|---|---|---|---|---|---|
| Arm/Group Description | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3 | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) | Participants 12 to 18 months of age received Hepatitis A vaccine |
| Measure Participants | 288 | 292 | 286 | 193 | 97 |
| JE CV Day 0 (N=288, 290, 285, 192, 0) |
10
3.3%
|
4
1.3%
|
8
2.7%
|
2
1%
|
NA
NaN
|
| JE CV Day 28 (N=288, 284, 283, 192, 0) |
297
98%
|
269
90%
|
276
93.2%
|
190
95.5%
|
NA
NaN
|
| Title | Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine |
|---|---|
| Description | Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay. |
| Time Frame | Day 0 (pre-vaccination) and Day 28 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric mean titers against the JE CV antigens were assessed in the Per Protocol Analysis Set. |
| Arm/Group Title | JE-CV GPO MBP (Lot 1) | JE-CV MBP (Lot 2) | JE-CV MBP (Lot 3) | JE-CV WRAIR | Hepatitis A |
|---|---|---|---|---|---|
| Arm/Group Description | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously | Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 2 subcutaneously | Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 3 subcutaneously | Participants 12 to 18 months of age received one dose of JE CV from Acambis at WRAIR subcutaneously | Participants 12 to 18 months of age received the Hepatitis vaccine intramuscularly |
| Measure Participants | 288 | 292 | 286 | 193 | 97 |
| Geometric Mean (95% Confidence Interval) [Titer ratio] |
41.1
|
32.9
|
36.6
|
42.2
|
NA
|
| Title | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine. |
|---|---|
| Description | Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >39.5˚C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal, >3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable. |
| Time Frame | Day 0 up to Day 14 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited injection site and systemic reactions were assessed in the Safety Analysis Set. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received. |
| Arm/Group Title | JE CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A |
|---|---|---|---|---|---|
| Arm/Group Description | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3 | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) | Participants 12 to 18 months of age received Hepatitis A vaccine |
| Measure Participants | 302 | 299 | 297 | 199 | 102 |
| Injection site Tenderness |
58
19.1%
|
59
19.7%
|
67
22.6%
|
59
29.6%
|
18
17.6%
|
| Grade 3 Injection site Tenderness |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Injection site Erythema |
64
21.1%
|
63
21.1%
|
87
29.4%
|
54
27.1%
|
26
25.5%
|
| Grade 3 Injection site Erythema |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Injection site Swelling |
22
7.3%
|
20
6.7%
|
21
7.1%
|
13
6.5%
|
4
3.9%
|
| Grade 3 Injection site Swelling |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Fever |
51
16.8%
|
62
20.7%
|
64
21.6%
|
48
24.1%
|
21
20.6%
|
| Grade 3 Fever |
3
1%
|
5
1.7%
|
3
1%
|
1
0.5%
|
0
0%
|
| Vomiting |
60
19.8%
|
57
19.1%
|
53
17.9%
|
39
19.6%
|
16
15.7%
|
| Grade 3 Vomiting |
3
1%
|
1
0.3%
|
1
0.3%
|
1
0.5%
|
1
1%
|
| Crying Abnormal |
58
19.1%
|
54
18.1%
|
50
16.9%
|
41
20.6%
|
21
20.6%
|
| Grade 3 Crying Abnormal |
1
0.3%
|
0
0%
|
1
0.3%
|
0
0%
|
0
0%
|
| Drowsiness |
58
19.1%
|
53
17.7%
|
53
17.9%
|
38
19.1%
|
20
19.6%
|
| Grade 3 Drowsiness |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Appetite Lost |
82
27.1%
|
71
23.7%
|
74
25%
|
57
28.6%
|
27
26.5%
|
| Grade 3 Appetite Lost |
3
1%
|
1
0.3%
|
1
0.3%
|
2
1%
|
0
0%
|
| Irritability |
91
30%
|
79
26.4%
|
79
26.7%
|
65
32.7%
|
28
27.5%
|
| Grade 3 Irritability |
2
0.7%
|
0
0%
|
1
0.3%
|
1
0.5%
|
1
1%
|
| Title | Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine. |
|---|---|
| Description | Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain <10 l/dil and anti-dengue against the 4 serotypes <10 l/dilution. |
| Time Frame | Day 0 (pre-vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serological status of Flavivirus infection was assessed in the Per-protocol Analysis Set. |
| Arm/Group Title | JE-CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A |
|---|---|---|---|---|---|
| Arm/Group Description | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3 | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) | Participants 12 to 18 months of age received Hepatitis A vaccine |
| Measure Participants | 288 | 292 | 285 | 192 | 97 |
| JE CV/dengue FV positive (N=288,290,285,192,97) |
19
6.3%
|
23
7.7%
|
32
10.8%
|
15
7.5%
|
13
12.7%
|
| JE CV/dengue FV negative (N=288,290,285,192,97) |
265
87.5%
|
266
89%
|
249
84.1%
|
176
88.4%
|
84
82.4%
|
| JE CV (N=288, 290, 285, 192, 97) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Dengue serotype 1 (N=284, 289, 282, 192, 97) |
17
5.6%
|
19
6.4%
|
28
9.5%
|
14
7%
|
13
12.7%
|
| Dengue serotype 2 (N=284, 289, 282, 192, 97) |
15
5%
|
18
6%
|
26
8.8%
|
11
5.5%
|
12
11.8%
|
| Dengue serotype 3 (N=284, 289, 282, 192, 97) |
16
5.3%
|
18
6%
|
27
9.1%
|
12
6%
|
11
10.8%
|
| Dengue serotype 4 (N=284, 289, 282, 192, 97) |
10
3.3%
|
6
2%
|
13
4.4%
|
7
3.5%
|
8
7.8%
|
Adverse Events
| Time Frame | Adverse events (AE) data were collected from Day 0 (post-vaccination) up to Day 180 post-vaccination. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The total (N) for solicited AEs in the table reflects participants for which diary cards were returned and with available data for the event during the period. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received. | |||||||||
| Arm/Group Title | JE-CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A | |||||
| Arm/Group Description | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3 | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) | Participants 12 to 18 months of age received Hepatitis A vaccine | |||||
All Cause Mortality |
||||||||||
| JE-CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| JE-CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/302 (3.3%) | 17/299 (5.7%) | 13/297 (4.4%) | 7/199 (3.5%) | 7/102 (6.9%) | |||||
| Infections and infestations | ||||||||||
| Bronchiolitis | 2/302 (0.7%) | 2 | 0/299 (0%) | 0 | 0/297 (0%) | 0 | 0/199 (0%) | 0 | 0/102 (0%) | 0 |
| Cellulitis | 0/302 (0%) | 0 | 0/299 (0%) | 0 | 2/297 (0.7%) | 2 | 0/199 (0%) | 0 | 0/102 (0%) | 0 |
| Gastroenteritis | 3/302 (1%) | 3 | 4/299 (1.3%) | 4 | 4/297 (1.3%) | 4 | 1/199 (0.5%) | 1 | 0/102 (0%) | 0 |
| Pneumonia | 3/302 (1%) | 3 | 3/299 (1%) | 3 | 3/297 (1%) | 3 | 2/199 (1%) | 2 | 1/102 (1%) | 1 |
| Pneumonia bacterial | 0/302 (0%) | 0 | 0/299 (0%) | 0 | 0/297 (0%) | 0 | 0/199 (0%) | 0 | 2/102 (2%) | 2 |
| Urinary tract infection | 0/302 (0%) | 0 | 3/299 (1%) | 3 | 0/297 (0%) | 0 | 0/199 (0%) | 0 | 0/102 (0%) | 0 |
| Amoebiasis | 0/302 (0%) | 0 | 0/299 (0%) | 0 | 0/297 (0%) | 0 | 1/199 (0.5%) | 1 | 0/102 (0%) | 0 |
| Bronchitis | 0/302 (0%) | 0 | 2/299 (0.7%) | 2 | 0/297 (0%) | 0 | 0/199 (0%) | 0 | 0/102 (0%) | 0 |
| Gastroenteritis viral | 1/302 (0.3%) | 1 | 0/299 (0%) | 0 | 0/297 (0%) | 0 | 0/199 (0%) | 0 | 0/102 (0%) | 0 |
| Influenza | 1/302 (0.3%) | 1 | 0/299 (0%) | 0 | 0/297 (0%) | 0 | 0/199 (0%) | 0 | 0/102 (0%) | 0 |
| Pneumonia viral | 0/302 (0%) | 0 | 0/299 (0%) | 0 | 0/297 (0%) | 0 | 1/199 (0.5%) | 1 | 0/102 (0%) | 0 |
| Varicella | 0/302 (0%) | 0 | 0/299 (0%) | 0 | 0/297 (0%) | 0 | 1/199 (0.5%) | 1 | 0/102 (0%) | 0 |
| Viral infection | 0/302 (0%) | 0 | 2/299 (0.7%) | 2 | 0/297 (0%) | 0 | 0/199 (0%) | 0 | 1/102 (1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Testicular yolk sac tumour stage III | 0/302 (0%) | 0 | 0/299 (0%) | 0 | 0/297 (0%) | 0 | 1/199 (0.5%) | 1 | 0/102 (0%) | 0 |
| Nervous system disorders | ||||||||||
| Febrile convulsion | 2/302 (0.7%) | 2 | 6/299 (2%) | 6 | 4/297 (1.3%) | 4 | 1/199 (0.5%) | 1 | 3/102 (2.9%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Asthma | 1/302 (0.3%) | 1 | 0/299 (0%) | 0 | 0/297 (0%) | 0 | 0/199 (0%) | 0 | 0/102 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||
| JE-CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 91/302 (30.1%) | 99/299 (33.1%) | 87/297 (29.3%) | 65/199 (32.7%) | 36/102 (35.3%) | |||||
| Gastrointestinal disorders | ||||||||||
| Vomiting | 60/302 (19.9%) | 60 | 57/299 (19.1%) | 57 | 53/297 (17.8%) | 53 | 39/199 (19.6%) | 39 | 16/102 (15.7%) | 16 |
| General disorders | ||||||||||
| Pyrexia | 2/302 (0.7%) | 2 | 6/299 (2%) | 6 | 6/297 (2%) | 6 | 10/199 (5%) | 10 | 1/102 (1%) | 1 |
| Injection site tenderness | 58/302 (19.2%) | 58 | 59/299 (19.7%) | 59 | 67/297 (22.6%) | 67 | 59/199 (29.6%) | 59 | 18/102 (17.6%) | 18 |
| Injection site erythema | 64/302 (21.2%) | 64 | 63/299 (21.1%) | 63 | 87/297 (29.3%) | 87 | 54/199 (27.1%) | 54 | 26/102 (25.5%) | 26 |
| Injection site swelling | 22/302 (7.3%) | 22 | 20/299 (6.7%) | 20 | 21/297 (7.1%) | 21 | 13/199 (6.5%) | 13 | 4/102 (3.9%) | 4 |
| Fever | 51/302 (16.9%) | 51 | 62/299 (20.7%) | 62 | 64/297 (21.5%) | 64 | 48/199 (24.1%) | 48 | 21/102 (20.6%) | 21 |
| Infections and infestations | ||||||||||
| Gastroenteritis | 19/302 (6.3%) | 21 | 18/299 (6%) | 19 | 11/297 (3.7%) | 11 | 10/199 (5%) | 11 | 5/102 (4.9%) | 5 |
| Nasopharyngitis | 24/302 (7.9%) | 25 | 18/299 (6%) | 18 | 22/297 (7.4%) | 22 | 21/199 (10.6%) | 26 | 5/102 (4.9%) | 5 |
| Upper respiratory tract infection | 84/302 (27.8%) | 99 | 78/299 (26.1%) | 88 | 72/297 (24.2%) | 79 | 52/199 (26.1%) | 58 | 36/102 (35.3%) | 42 |
| Metabolism and nutrition disorders | ||||||||||
| Appetite Lost | 82/302 (27.2%) | 82 | 71/299 (23.7%) | 71 | 74/297 (24.9%) | 74 | 57/199 (28.6%) | 57 | 27/102 (26.5%) | 27 |
| Nervous system disorders | ||||||||||
| Drowsiness | 58/302 (19.2%) | 58 | 53/299 (17.7%) | 53 | 53/297 (17.8%) | 53 | 38/199 (19.1%) | 38 | 20/102 (19.6%) | 20 |
| Psychiatric disorders | ||||||||||
| Crying Abnormal | 58/302 (19.2%) | 58 | 54/299 (18.1%) | 54 | 50/297 (16.8%) | 50 | 41/199 (20.6%) | 41 | 21/102 (20.6%) | 21 |
| Irritability | 91/302 (30.1%) | 91 | 79/299 (26.4%) | 79 | 79/297 (26.6%) | 79 | 65/199 (32.7%) | 65 | 28/102 (27.5%) | 28 |
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:
NCT00735644
Other Study ID Numbers:
- JEC02
First Posted:
Aug 15, 2008
Last Update Posted:
Apr 21, 2015
Last Verified:
Apr 1, 2015