Influenza Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Trial of the Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal
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.
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 healthy children will be randomized in a 2:1 ratio of LAIV to placebo.
For evaluation of efficacy, passive and active surveillance will be conducted weekly
throughout the study to identify outcomes among vaccinated subjects. Children meeting the
protocol-defined clinical case definition will have a nasal swab and throat swab specimen
collected for testing by rRT-PCR for evidence of influenza virus infection.
100 of the 1,761 participants were also included in a substudy designed to evaluate
virologic evidence of LAIV replication. As such, nasal and throat swab specimens were
collected on day 0 (prior to vaccination), as well as on post-vaccination days 2, and 4 from
all subjects included in the substudy. These specimens will be tested for presence of
wild-type and vaccine virus. Additionally, a more detailed assessment of vaccine
reactogenicity will be made among these children by actively collecting solicited and
unsolicited reactions at each study visit for the week post vaccination (days 2 and 4).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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