Phase 3
N=519
Determining Long-Term Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Encephalitis, Japanese B
Bottom Line
View on ClinicalTrials.gov: NCT00412516 ↗Enrolled (actual)
519
Serious AEs
6.0%
Results posted
Oct 2014
Primary outcome: Primary: Measles Seropositivity at 24 and 36 Months — 98.92; 95.75; 94.37; 94.62 percentage of participants seropositive
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Live attenuated SA 14-14-2 vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measles Seropositivity at 24 and 36 Months |
98.92; 95.75; 94.37; 94.62; 91.39; 91.04 | — |
| SECONDARY Measles Seropositivity at 12 Months |
87.64; 87.32; 87.2 | — |
| SECONDARY Seropositive Rate for Japanese Encephalitis (JE) Antibody in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination. |
90.4; 83.5; 86.1; 81.1; 83.8; 80.7 | — |
| SECONDARY Geometric Mean Neutralizing Antibody Titer to Japanese Encephalitis (JE) Virus in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination. |
108; 83; 77; 67; 64; 70 | — |
Summary
The previously conducted JEV01 study looked at the immunogenicity and safety of the concurrent administration of Japanese Live Attenuated SA 14-14-2 and measles vaccines at the one month post vaccination time point. The purpose of the JEV01 study was to help ensure the safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its use in routine EPI programs. As a follow-on to JEV01, this study will enroll those infants who received both vaccines and completed the JEV01 study. This study, however, will provide crucial data to help ensure the long-term immunogenicity of the concurrent administration of these vaccines and provide valuable information to determine the use of these vaccines in routine immunization programs. This study is planned because in the original protocol for JEV01, long-term data points were not included. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time have long-term (24 and 36 months post vaccination) protection against these diseases at the same level as those who receive the vaccines at different intervals.
Eligibility Criteria
Inclusion Criteria
- Participant was enrolled in the JEV01 study previously conducted at RITM.
- Participant completed his/her vaccination schedule for the JEV01 study previously conducted at RITM.
- Participant's blood test results from JEV01 study indicate that he/she had seroconverted to measles vaccination.
- Participant's parents or legal guardian are/is willing to provide signed informed consent.
Exclusion Criteria
- Participant was withdrawn from the JEV01 study for any reason.
- Receipt of immune globulin or other blood products within 6 months of study (JEV02) entry or receipt of injected or oral corticosteroids or other immune modulator therapy (except routine vaccines) within 4 weeks of study (JEV02) entry.
- Any condition that in the opinion of the investigator, would interfere with the evaluation of the study objectives.
Data sourced from ClinicalTrials.gov (NCT00412516). 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.