Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: SIIL Live Attenuated Influenza Vaccine; Matched placebo
Intervention description: Trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010; Matched placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1761.0
Sex: All
Minimum age: 24 Months
Maximum age: 71 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza vaccine; trivalent live-attenuated influenza vaccine; efficacy; Africa; Senegal

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 influenza vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.