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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,761
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.
Institut de Recherche pour le Développement (IRD), Niakhar station
Niakhar, Senegal
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match)
Time frame: Through 7 to 8 months post vaccination
Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine.
Time frame: Through 30 minutes post vaccination
Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions
Time frame: Through 7 days post vaccination
Safety Profile of LAIV: Serious Adverse Events
Time frame: Through 1 month post vaccination
Safety Profile of LAIV: Other Non-serious Adverse Events
Time frame: Through 1 month post vaccination
Safety Profile of LAIV: Protocol Defined Wheezing Illness
Time frame: Through 7 to 8 months post vaccination
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains)
Time frame: Through 7 to 8 months post vaccination
Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection by Influenza Type/Subtype (Influenza A/H1N1, Influenza A/H3N2, and Influenza B)
Time frame: Through 7 to 8 months post vaccination
Clinical Characteristics of Influenza in the Study Population
Time frame: Through 7 to 8 months post vaccination
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Etiologies of Influenza-like Illness in the Study Population
Bacterial and viral etiologies of acute respiratory and febrile illness will be parameterized as the percentage of those with each particular laboratory-confirmed infection categorized by vaccine allocation.
Time frame: Through 7 to 8 months post vaccination
Evaluation of Vaccine-take as Shedding of Vaccine Virus Post-vaccination, Including Viral Load and Duration of Virus Detection
Vaccine take will be parameterized as the percentage of participants with detectable vaccine-virus in nasal or throat swab on each day pre- (day 0) and post vaccination (i.e., 2 and 4 days post vaccination), and the quantity of detected virus.
Time frame: Through 4 days post vaccination