Phase 4
N=818
Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT01567865 ↗Enrolled (actual)
818
Serious AEs
1.2%
Results posted
Nov 2018
Primary outcome: Primary: Number/Percentage of Subjects With Demonstrated Seroprotection — 126; 160; 154; 164 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vaccine produced in existing facility (Biological); Vaccine produced in new facility (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number/Percentage of Subjects With Demonstrated Seroprotection |
126; 160; 154; 164; 478; 20 | <0.05 sig |
| PRIMARY Geometric Mean Titers (GMT) |
77.3; 52.8; 53.4; 62.8; 56.2 | — |
| SECONDARY Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE) |
0; 6; 5; 2; 163; 214 | — |
| SECONDARY Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination |
51; 75; 81; 61; 112; 145 | — |
| SECONDARY Number/Percentage of Subjects With Other Adverse Events (AE) During the Study |
60; 84; 92; 77; 103; 136 | — |
Summary
The proposed study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured in a new good manufacture practice (GMP) facility, and to establish non-inferiority of the new vaccine in comparison to a single lot of the same vaccine manufactured in the existing facility. The study aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, this study provided local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is the first step to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.
Eligibility Criteria
Inclusion Criteria
- Infant's parent(s) or legal guardian(s) willing to provide signed informed consent.
- Healthy infants aged 10 to 12 months at enrolment residing in Matlab Health and Demographic Surveillance System (HDSS) intervention area who have completed all doses of Expanded Programme on Immunization (EPI) immunizations at least 4 weeks prior to enrolment: Bacillus Calmette-Guerin vaccine (BCG), Diphtheria-pertussis-tetanus vaccine (DPT), Hepatitis B (HBV), Haemophilus influenzae type (Hib), oral polio vaccine (OPV) and measles
Exclusion Criteria
- Acute medical illness with or without fever within the last 72 hours or an axillary temperature (≥ 37.5°C ) at the time of vaccination.
- Use of antibiotics or antipyretics within the last 72 hours prior to enrolment.
- Severely or moderately malnourished infants (<-3 Z score).
- History of prematurity (< 36 weeks of pregnancy).
- Underlying medical condition such as failure to thrive, inborn errors of metabolism, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
- History of serious chronic disease (e.g., cardiac, renal, neurologic, metabolic, rheumatologic, hematologic, or bleeding disorder).
- Known or suspected impairment of immunologic function.
- History of documented or suspected encephalitis or meningitis.
- History of seizures, including history of febrile seizures, or any other neurologic disorder.
- History of JE infection.
- Prior receipt of a JE vaccine.
- Received measles vaccine within 4 weeks prior to, or scheduled to receive a vaccination during, the conduct of this trial.
- Prior or anticipated receipt of immune globulin or other blood products, or injected or oral corticosteroids or other immune modulator therapy within 6 weeks of administration of the study vaccine.
- Serious adverse reactions (e.g. urticaria, angioedema, shock, breathlessness following vaccination or any life threatening condition) with any previous EPI vaccine.
- 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 child, or interfere with the evaluation of the study objectives.
Data sourced from ClinicalTrials.gov (NCT01567865). 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.