Phase 3
N=600
Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Encephalitis, Japanese B
Bottom Line
View on ClinicalTrials.gov: NCT00249769 ↗Enrolled (actual)
600
Serious AEs
2.1%
Results posted
Mar 2020
Primary outcome: Primary: Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination — 1.1; 0.0; 0.0; 88.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) (Biological); Measles Vaccine (MV) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination |
1.1; 0.0; 0.0; 88.6; 91.8; 86.5 | — |
| SECONDARY Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination |
3.4; 5.4; 6.1; 92.1; 90.5; 90.6 | — |
| SECONDARY Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination |
12.8; 7.4; 7.0; 318.9; 301.9; 262.5 | — |
| SECONDARY Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination |
5.7; 5.7; 5.9; 202.8; 155.0; 139.4 | — |
| SECONDARY Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV) |
27; 53; 27; 19; 48; 22 | — |
| SECONDARY Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine |
19; 44; 61; 15; 42; 50 | — |
| SECONDARY Number of Participants Experiencing Unsolicited Adverse Events (AE) |
35; 43; 79; 0; 4; 2 | — |
Summary
This study will determine whether it is safe and effective to administer Japanese encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If it is found to be safe, it will pave the way for use in routine vaccination programs. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time are protected against these diseases at the same level as those who receive the vaccines at different intervals.
Eligibility Criteria
Inclusion Criteria
- Participant is healthy, aged between 8 months (± 2 weeks) at inclusion visit
- Subject is a full-term infant
- Subject's parents or legal guardian willing to provide signed informed consent.
- Children have completed 3 doses each of diphtheria, tetanus, pertussis (DTP) and oral polio vaccine (OPV).
Exclusion Criteria
- History of documented HIV.
- Known or suspected impairment of immunologic function.
- History of serious chronic disease
- Underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
- Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5°C at the time of inclusion.
- History of documented suspected encephalitis, encephalopathy, or meningitis
- History of measles
- History of thrombocytopenic purpura.
- Received any JE or measles vaccine prior to enrollment.
- Received any vaccine, other than the study vaccines, within 2 weeks prior to or scheduled to receive a non-study vaccination during the conduct of this trial.
- Hypotonic - hyporesponsiveness, after the preceding vaccination.
- History of seizures, including history of febrile seizures, or any other neurologic disorder.
- Prior or anticipated receipt of immune globulin or other blood products, or injected or oral corticosteroids or other immune modulator therapy except routine vaccines within 6 weeks of administration of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting 3 hours) observed after a previous dose.
- Unable to attend the scheduled visits or comply with the study procedures.
- Enrolled in another clinical trial involving any therapy.
- Any condition that in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the study objectives.
Data sourced from ClinicalTrials.gov (NCT00249769). 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.