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About
The purpose of the study is to get a better understanding of the natural and adaptive immune response to the flu virus and to compare the immune cell responses to FDA-licensed flu vaccines in nasal mucosal cells and in blood.
Full description
This is a study of healthy children and adults receive the current seasonal influenza vaccine. The volunteers were enrolled into one of 7 groups over a 5-year period. Immunization is administered; blood samples and NP swabs are collected at various time points based on groups assigned.
Group A (LAIV4/annual return): Up to six 2-4 year old volunteers are given a quadrivalent live, attenuated influenza vaccine (LAIV4). All participants in this group are asked to return annually for flu immunization and blood samples on Day 0 and Day 7 post immunization. Vaccine naive children returned 30 days later for a second immunization per standard of care. This group was discontinued in year 3 due to Advisory Committee on Immunization Practices (ACIP) recommendations against the use of LAIV.
Group B (LAIV4/ single year): Up to twenty 2-4 year old volunteers were given a quadrivalent live, attenuated influenza vaccine (LAIV4). Volunteers will participate for a single year. All participants in this group were immunized on Day 0. Blood samples were taken on on Day 0 and Day 7 post immunization. Vaccine naive children returned 30 days later for a second immunization per standard of care. This group was discontinued in year 3 due to ACIP recommendations against the use of LAIV.
Group C (LAIV4/NP swab group): Up to twenty 2-4 year old volunteers were given a quadrivalent live, attenuated influenza vaccine (LAIV4). Nasopharyngeal samples (NP) swabs were collected Day 1 and 21 and 28 post immunization. No blood was collected for this group. Vaccine naive children returned 30 days later for a second immunization per standard of care. This group was discontinued in year 3 due to ACIP recommendations against the use of LAIV.
Group D (IIV4/annual return): Up to six 6 month-23 month old (inclusive) volunteers are given a quadrivalent inactivated influenza vaccine (IIV4). All participants in this group are asked to return annually for flu immunization and blood samples on Day 0 and Day 7 post immunization. Vaccine naive children returned 30 days later for a second immunization per standard of care.
Group E (IIV4/single year): Up to twenty 6 month-23 month old (inclusive) volunteers were given a quadrivalent inactivated influenza vaccine (IIV4). Volunteers participate for a single year. All participants in this group were immunized on Day 0. Blood samples were taken on on Day 0 and Day 7 post immunization. Vaccine naive children returned 30 days later for a second immunization per standard of care.
Group F (LAIV4/single year) Up to forty 9-13 year old (n= 20) and 18-49 year old (n= 20) volunteers were given live, attenuated influenza vaccine (LAIV). Blood samples were collected Days 0, 7, and 28 and NP swabs were collected Days 1 and 28. This group was discontinued in year 3 due to ACIP recommendations against the use of LAIV.
Group G (IIV4/single year) Up to forty, 9-13 year old (n= 20) and 18-49 year old (n= 20) volunteers were given a quadrivalent inactivated influenza vaccine (IIV4). Blood samples were collected Day 0,7, and 28
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77 participants in 7 patient groups
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Data sourced from clinicaltrials.gov
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