Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine
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ClinicalTrials.gov Identifier: NCT02880865 |
Recruitment Status :
Completed
First Posted : August 26, 2016
Results First Posted : September 18, 2020
Last Update Posted : October 14, 2020
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Sponsor:
PATH
Collaborators:
Research Institute for Tropical Medicine,
Syneos Health
DF/Net Research, Inc.
Information provided by (Responsible Party):
PATH
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Encephalitis, Japanese Measles Mumps Rubella |
Interventions |
Biological: Live attenuated SA 14-14-2 Japanese Encephalitis vaccine Biological: Measles, mumps, rubella vaccine |
Enrollment | 628 |
Participant Flow
Recruitment Details | Participants were enrolled at 2 health centers in the Philippines. |
Pre-assignment Details | Filipino children aged 9 to < 10 months were randomized in a 1:1 ratio to receive measles, mumps, and rubella vaccine (MMR) and prequalified live, attenuated SA-14-4-2 Japanese encephalitis vaccine (CD-JEV) together (Group 1) or 56 days apart (Group 2). All participants received a second dose of MMR at 12 months of age. |
Arm/Group Title | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV |
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Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age). | Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age). |
Period Title: Overall Study | ||
Started | 314 | 314 |
Received MMR Dose 1 | 314 | 314 |
Received CD-JEV | 314 | 309 |
Received MMR Dose 2 | 313 | 311 |
Completed | 313 | 311 |
Not Completed | 1 | 3 |
Reason Not Completed | ||
Adverse Event | 1 | 0 |
Withdrawal by Subject | 0 | 2 |
Physician Decision | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Group 1: MMR and CD-JEV | Group 2: MMR Then CD-JEV | Total | |
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Participants received one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age). | Participants received one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Participants received a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age). | Total of all reporting groups | |
Overall Number of Baseline Participants | 314 | 314 | 628 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Months |
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Number Analyzed | 314 participants | 314 participants | 628 participants | |
9.2
(9.0 to 10.0)
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9.2
(9.0 to 10.0)
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9.2
(9.0 to 10.0)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 314 participants | 314 participants | 628 participants | |
Female |
144 45.9%
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157 50.0%
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301 47.9%
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Male |
170 54.1%
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157 50.0%
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327 52.1%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | 0 participants | 0 participants | |
0 | ||||
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Philippines | Number Analyzed | 314 participants | 314 participants | 628 participants |
314 | 314 | 628 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Jorge Flores, MD |
Organization: | PATH |
Phone: | (202) 822-0033 |
EMail: | jeflores@path.org |
Responsible Party: | PATH |
ClinicalTrials.gov Identifier: | NCT02880865 |
Other Study ID Numbers: |
JEV06 PHRR160822-001339 ( Registry Identifier: Philippine Health Research Registry (PHRR) ) |
First Submitted: | August 17, 2016 |
First Posted: | August 26, 2016 |
Results First Submitted: | August 27, 2020 |
Results First Posted: | September 18, 2020 |
Last Update Posted: | October 14, 2020 |