Clinical trial NCT01567865: Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine
Official title: A Clinical Trial in Healthy Infants to Assess Lot-to-lot Consistency of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Non-inferiority With Respect to an Earlier Product.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Japanese Encephalitis
Lead sponsor: PATH
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 818
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Number/Percentage of Subjects With Demonstrated Seroprotection
timeFrame: 28 days post-vaccination
measure: Geometric Mean Titers (GMT)
timeFrame: 28 days post-vaccination
Secondary outcomes:
measure: Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE)
timeFrame: Within 30 minutes of vaccination
measure: Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination
timeFrame: Within 7 days of vaccination
measure: Number/Percentage of Subjects With Other Adverse Events (AE) During the Study
timeFrame: Between 7 and 28 days of vaccination
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: ICDDR,B
Study officials:
affiliation: ICCDR,B
name: K Zaman, MD
role: PRINCIPAL_INVESTIGATOR
References: