Phase 4
N=628
Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine
Encephalitis, Japanese · Measles · Mumps · Rubella
Bottom Line
View on ClinicalTrials.gov: NCT02880865 ↗Enrolled (actual)
628
Serious AEs
1.5%
Results posted
Sep 2020
Primary outcome: Primary: Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination — 98.1; 98.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Live attenuated SA 14-14-2 Japanese Encephalitis vaccine (Biological); Measles, mumps, rubella vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination |
98.1; 98.0 | — |
| PRIMARY Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination |
100.0; 99.7 | — |
| SECONDARY Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination |
98.5; 98.5 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination |
1964.4; 1866.3 | — |
| SECONDARY GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination |
230.8; 229.8 | — |
| SECONDARY Seroconversion Rate for Measles 56 Days Post-vaccination |
98.1; 98.0 | — |
| SECONDARY Seroconversion Rate for Mumps 56 Days Post-vaccination |
96.7; 95.1 | — |
| SECONDARY Seroconversion Rate for Rubella 56 Days Post-vaccination |
100.0; 99.7 | — |
| SECONDARY Percentage of Participants With Japanese Encephalitis Seropositivity 28 Days Post-vaccination |
72.3; 68.2 | — |
| SECONDARY Geometric Mean Titer (GMT) for Serum Neutralizing Antibody Titer to JE Virus at 28 Days Post-vaccination |
24.0; 20.3 | — |
| SECONDARY Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination |
6; 3; 5; 5; 3; 3 | — |
| SECONDARY Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination |
35; 31; 12; 9; 34; 13 | — |
| SECONDARY Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity |
6; 6; 10; 3; 0; 5 | — |
| SECONDARY Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity |
135; 119; 87; 79; 84; 52 | — |
| SECONDARY Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination |
207; 211; 164; 110; 148; 35 | — |
| SECONDARY Number of Participants With Serious Adverse Events Throughout the Study |
8; 15; 0; 0 | — |
Summary
This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not adversely affect immunogenicity or safety.
Eligibility Criteria
Inclusion Criteria
- Age 9 months to 7 days) of immunosuppressing or other immune-modifying agents within 14 days before or after vaccination (including systemic corticosteroids equivalent to prednisone ≥ 0.5 mg/kg/day; topical and inhaled steroids are allowed).
- Primary or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency as reported by parent.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history or physical examination, which might interfere with the study objectives.
- Severely malnourished infants as measured by World Health Organization weight-for-height tables (Z-score < -3).
- Any condition or criterion that, in the opinion of the study physician, might compromise the well-being of the participant, compliance with study procedures, or interpretation of the outcomes of the study.
- Acute illness at the time of enrollment defined as the presence of a moderate or severe illness with fever (axillary temperature ≥ 38.0°C) or without fever (severity determined at the discretion of the study physician). Acute illness is a temporary exclusion. Vaccination should be postponed at least 7 days after recovery. A visit for reassessment may be scheduled 7 days or more after temporary exclusion illness is resolved. Eligibility for study participation must be reassessed again at the next visit.
Data sourced from ClinicalTrials.gov (NCT02880865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.