Status:
COMPLETED
Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal
Lead Sponsor:
PATH
Collaborating Sponsors:
Institut de Recherche pour le Developpement
Institut Pasteur de Dakar
Conditions:
Influenza
Eligibility:
All Genders
24-71 years
Phase:
PHASE3
Brief Summary
This study will provide the Senegal Ministry of Health with data on the clinical efficacy of the Live-Attenuated Influenza Vaccine (LAIV). This data will inform future policy considerations for influe...
Detailed Description
This study is a double-blind, individual-randomized, placebo-controlled, clinical efficacy trial among healthy children aged 24 through 71 months in the Niakhar area of Senegal. A total of 1,761 healt...
Eligibility Criteria
Inclusion
- Healthy male or female child at least 24 months of age and no older than 71 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 Niakhar DSS 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
- Serious, active, medical condition, including: 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 of any kind.
- 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.
- History of Guillain-Barré syndrome.
- Receipt of immunosuppressive agents, including systemic corticosteroids, during the month before planned study vaccination.
- Receipt of aspirin therapy or aspirin-containing therapy within the two weeks before planned study vaccination.
- History of any severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis.
- Receipt of an influenza vaccine within the past 12 months.
- 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 Contraindications:
- Acute illness accompanied by a body temperature of 37.5°C or above (axillary measurement) within 14 days of enrollment visit.
- Any acute respiratory infection within 14 days of enrollment visit.
- Any illness accompanied by active wheezing within 14 days of enrollment visit.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
1761 Patients enrolled
Trial Details
Trial ID
NCT01854632
Start Date
May 1 2013
End Date
December 1 2013
Last Update
June 3 2015
Active Locations (1)
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1
Institut de Recherche pour le Développement (IRD), Niakhar station
Niakhar, Senegal