This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old.
The potential for widespread human disease due to the H3N2v influenza viruses is considerable. Infection with these viruses would most likely impact young children. This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old. The study will enroll participants sequentially in four groups: Group 1 will include H3N2v seronegative adults ages 18-26 years; Group 2 will include H3N2v seropositive adolescents ages 13-17 years; Group 3 will include H3N2v seronegative adolescents ages 13-17 years; and Group 4 will include children ages 6 to 12 years, who will not be screened for H3N2v serostatus. At study entry (Day 0), participants in Group 1 will receive one dose of H3N2v LAIV. Participants in Groups 2, 3, and 4 will be randomly assigned to receive two doses of either H3N2v LAIV or placebo, receiving the first dose on Day 0 and the second dose on Day 28. On Day 84, all participants will receive one dose of H3N2v IIV (an inactivated booster vaccine). Participants will attend several additional study visits through Day 180. These visits may include a physical examination; respiratory examination; and collection of blood, urine, or nasal fluids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1
Approximately 10\^7.0 Fluorescent Focus Units (FFU) per 0.2 mL dose; administered intranasally
15 μg; administered intramuscularly
Administered by nasal spray
University of Rochester Medical Center (URMC), Vaccine Research Unit (Outpatient)
Rochester, New York, United States
Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study
Time frame: Measured through Day 180
Area under the curve of nasal virus shedding after each dose of vaccine
As assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C
Time frame: Measured through Day 180
Development of serum antibody
Assessed by either hemagglutination inhibition (HAI) or microneutralization (MN) assays
Time frame: Measured through Day 180
Development of a significant increase in nasal secretion hemagglutinin (HA)-specific antibody
Assessed by enzyme-linked immunosorbent assay (ELISA), luminex or microneutralization assay
Time frame: Measured through Day 180
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