Status:
COMPLETED
A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh
Lead Sponsor:
PATH
Collaborating Sponsors:
Johns Hopkins University
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Influenza
Eligibility:
All Genders
24-59 years
Phase:
PHASE3
Brief Summary
This is a single center, multi-site, double-blind, parallel group, placebo-controlled trial of the clinical efficacy of trivalent Serum Institute of India, Ltd. (SIIL)live-attenuated influenza vaccine...
Eligibility Criteria
Inclusion
- Healthy male or female child at least 24 months of age and no older than 59 months of age at the time of study vaccination.
- A child whose parent or guardian's primary residence, at the time of study vaccinations, is within the Kamalapur surveillance site catchment area or Matlab service area and who intends to be present in the area for the duration of the trial.
- A child whose parent or legal guardian is willing to provide written informed consent prior to the participant's study vaccination.
Exclusion
- Has any serious, active, medical conditions, including: a chronic disease of any body system, chronic infections such as tuberculosis, genetic disorders, such as Down's syndrome or other cytogenetic disorder, known or suspected disease of the immune system.
- Is receiving immunosuppressive agents, including systemic corticosteroids, during the month prior to study vaccination.
- Has a history of documented hypersensitivity to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with life-threatening reactions to previous influenza vaccinations.
- Has ever received influenza vaccine (LAIV or inactivated).
- History of Guillain-Barre syndrome
- Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks before.
- Lives in household with somebody currently participating in a respiratory vaccination or antiviral study.
- Has current or past participation (within 2 months of trial enrollment visit) in any clinical trial involving a drug or biologic with activity against respiratory disease.
- History of a previous severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis.
- Has any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the child or make it unlikely that the child would complete the study
- Temporary Inclusion Contraindications:
- Concurrent febrile illness (measured temperature 38 degrees C axillary).
- Active wheezing illness
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
1761 Patients enrolled
Trial Details
Trial ID
NCT01797029
Start Date
February 1 2013
End Date
September 1 2014
Last Update
June 11 2015
Active Locations (2)
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1
icddr, b Kamalapur
Dhaka, Bangladesh
2
icddr,b Matlab
Matlab, Bangladesh