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Phase 4 N=628 Randomized Prevention

Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine

Encephalitis, Japanese · Measles · Mumps · Rubella

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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