Phase 4
N=278
Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00463684 ↗Enrolled (actual)
278
Serious AEs
16.2%
Results posted
Feb 2019
Primary outcome: Primary: Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies — 14; 243; 233; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (Biological); Live, attenuated measles vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies |
14; 243; 233; 24; 202; 41 | — |
| PRIMARY Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition |
0; 257; 218; 39; 229; 14 | — |
| PRIMARY Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects |
0; 257; 244; 13; 229; 14 | — |
| SECONDARY Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies |
5.5; 110.6; 68.3; 75.5 | — |
| SECONDARY Geometric Mean Titer (GMT) of Anti-measles Immunoglobulin G (IgG) |
20.5; 374.9; 697.8; 1201.7 | — |
| SECONDARY Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) |
0; 254; 34; 244; 27; 251 | — |
| SECONDARY Number of Solicited Local Reactions to LJEV: Days 0-3 |
34; 0; 11; 0; 7; 0 | — |
| SECONDARY Number of Solicited Local Reactions to LJEV: Days 4-7 |
2; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Solicited Local Reactions to Measles Vaccine: Days 0-3 |
27; 0; 11; 0; 6; 0 | — |
| SECONDARY Number of Solicited Local Reactions to Measles Vaccine: Days 4-7 |
1; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Solicited Systemic Reactions: Days 0-3 |
105; 4; 21; 0; 52; 0 | — |
| SECONDARY Number of Solicited Systemic Reactions: Days 4-7 |
55; 2; 14; 0; 32; 0 | — |
Summary
To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and measles vaccine at 9 months of age. The primary hypothesis was that the seropositivity rate at 28 days post vaccination in Japanese Encephalitis (JE) and measles concomitantly vaccinated subjects 9 months of age is greater than 80% for JE and greater than 90% for measles.
Eligibility Criteria
Inclusion Criteria
- Healthy child 9 months (±2 weeks) of age at the enrollment visit.
- Subject was a full-term infant.
- Subject's parent or legal guardian is literate and willing to provide written informed consent.
- Subject is up-to-date for all vaccinations recommended in the Sri Lankan childhood immunization schedule.
Exclusion Criteria
- Enrolled in another clinical trial involving any therapy.
- Subject and/or parent(s) or guardian(s) are unable to attend the scheduled visits or comply with the study procedures.
- Received any non-study vaccine within 2 weeks prior to enrolment or refusal to postpone receipt of such vaccines until 28 days after study entry.
- 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 study vaccine. Individuals on a tapering dose schedule of oral steroids lasting 3 hours) observed after previous receipt of any JE vaccine, if applicable.
- Hypotonic - hyporesponsiveness after past receipt of any JE vaccine, if applicable.
- Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
- History of serious chronic disease (cardiac, renal, neurologic, metabolic, or rheumatologic).
- Underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
- History of thrombocytopenic purpura.
- History of seizures, including history of febrile seizures, or any other neurologic disorder.
- Known or suspected immunologic function impairment of any kind and/or known HIV infection.
- Parent with known or suspected immunologic function impairment of any kind and/or known HIV infection.
- 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 (NCT00463684). 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.