Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age (FluMist)
Influenza, Healthy
About this trial
This is an interventional prevention trial for Influenza focused on measuring FluMist Quadrivalent, Trivalent, Influenza, Vaccine, Prevention
Eligibility Criteria
Key Inclusion Criteria:
- Age 24 months to < 48 months of age
- Healthy by medical history and physical examination or presence of stable underlying chronic medical condition for which hospitalization has not been required in the previous year
Key Exclusion Criteria:
- History of allergic disease or reactions likely to be exacerbated by any component of the investigational product
- Acute illness or evidence of significant active infection (including fever >= 100.4 degrees Fahrenheit (38.0 degrees Celsius) at randomization
- History of asthma or history of recurrent wheezing
- Any known immunosuppressive condition or immune deficiency disease
- Current or expected receipt of immunosuppressive medications within a 28 day window around vaccination
- Use of aspirin or salicylate-containing medications within 28 days prior to randomization or expected receipt thru 28 days after vaccination
- Use of antiviral agents with activity against influenza viruses within 48 hours prior to first dose of investigational product or anticipated use of such agents through the end of the study follow-up period
- Receipt of any non-study seasonal influenza vaccine within 90 days of Dose 1 or planned receipt of non-study seasonal influenza vaccine prior to 28 days after last vaccination
- Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation
- Known or suspected mitochondrial encephalomyopathy
- History of Guillian-Barre syndrome
- Administration of intranasal medications within 10 days prior to randomization, for expected receipt through 10 days after administration of each dose of investigational product
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
FluMist trivalent (2015-2016)
FluMist Quadrivalent (2015-2016)
FluMist Quadrivalent (2017-2018)
Participants will receive intranasal spray of 0.2 milliliter (mL) (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 fluorescent focus units (FFU) of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).
Participants will receive intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
Participants will receive intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).