Lot-to-lot Consistency Trial of JE Live Attenuated SA 14-14-2 Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01567865
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : August 5, 2013
Information provided by (Responsible Party):

Brief Summary:
The proposed JEV05 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 JE live attenuated SA 14-14-2 vaccine manufactured in a new 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 will enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, JEV05 will provide local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This will be 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.

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: JE live attenuated SA 14-14-2 vaccine Phase 4

Study Type : Interventional  (Clinical Trial)
Official Title: A Clinical Trial in Healthy Infants to Assess Lot-to-lot Consistency of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine Manufactured in a New Good Manufacturing Practices Facility and Non-inferiority With Respect to an Earlier Product.
Study Start Date : May 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Arm Intervention/treatment
Experimental: JE live attenuated SA 14-14-2 vaccine Biological: JE live attenuated SA 14-14-2 vaccine

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 HDSS intervention area who have completed all doses of EPI immunizations (BCG, DPT, HBV, Hib, OPV and measles) at least 4 weeks prior to enrolment.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01567865

Dhaka, Bangladesh
Sponsors and Collaborators
Principal Investigator: K Zaman, MD ICCDR,B

Responsible Party: PATH Identifier: NCT01567865     History of Changes
Other Study ID Numbers: JEV05 (VAC004)
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: March 2012

Additional relevant MeSH terms:
Encephalitis, Japanese
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs