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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01567865
First received: March 28, 2012
Last updated: August 2, 2013
Last verified: March 2012
  Purpose

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 Intervention Phase
Japanese Encephalitis
Biological: JE live attenuated SA 14-14-2 vaccine
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by PATH:

Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JE live attenuated SA 14-14-2 vaccine Biological: JE live attenuated SA 14-14-2 vaccine

  Eligibility

Ages Eligible for Study:   10 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567865

Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: K Zaman, MD ICCDR,B
  More Information

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01567865     History of Changes
Other Study ID Numbers: JEV05 (VAC004)
Study First Received: March 28, 2012
Last Updated: August 2, 2013
Health Authority: Bangladesh: Ethical Review Committee

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014