Influenza
Conditions
Keywords
Inactivated influenza vaccine, Live, attenuated influenza vaccine, Young children, Adults
Brief summary
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.
Detailed 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
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
1. Otherwise healthy, 6 mo-49 year-old volunteers. 2. Willing to complete the informed consent process (including assent for minors 7-17 years of age). 3. Availability for follow-up for the planned duration of the study. 4. For parents of children 6 months - 4 years of age: Willing to participate in the study annually for up to 5 years (if yes, consider for annual return groups). 5. Acceptable medical history by review of inclusion/
Exclusion criteria
and vital signs. 6. Influenza vaccine-naive or only one prior season of flu immunization with IIV (does not apply to Groups F and G).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Count of Participants From Each Arm Who Received Influenza Vaccine | Day 0 to 28-32 post immunization |
Secondary
| Measure | Time frame |
|---|---|
| Count of Participants With Related Adverse Events | Day 0 to 28-32 post-immunization |
Countries
United States
Participant flow
Recruitment details
Participants are presented only in the group in the year in which they received the vaccination. Planned Groups B and C did not enroll in years 2014-2018, Group A did not enroll in 2015-2018 and Group F did not enroll in years 2016-2018 due to LAIV not being recommended.
Participants by arm
| Arm | Count |
|---|---|
| Group A: 2-4 yo LAIV4 (Return) Participants are given quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® . For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1. All participants in this group will be asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray | 1 |
| Group D: 6 - 23 Mos Old IIV4 (Return) Participants are given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1. Participants are asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine | 6 |
| Group E: 6 - 23 Mos Old IIV4 (Single Yr) Participants are given IIV4/ Fluzone® and participate for a single year. For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine | 2 |
| Group F: 9-13/18-49 yo LAIV4 (Single Yr) Participants 9-13 year old and 18-49 year old are given LAIV4/ FluMist® . Participants will participate for a single year.
FluMist®: FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray | 21 |
| Group G: 9-13/18-49 yo IIV4 (Single Yr) Participants 9-13 year old and 18-49 year old are given IIV4/ Fluzone® and participate for single year.
Fluzone®: Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine | 47 |
| Total | 77 |
Baseline characteristics
| Characteristic | Group G: 9-13/18-49 yo IIV4 (Single Yr) | Total | Group A: 2-4 yo LAIV4 (Return) | Group D: 6 - 23 Mos Old IIV4 (Return) | Group E: 6 - 23 Mos Old IIV4 (Single Yr) | Group F: 9-13/18-49 yo LAIV4 (Single Yr) |
|---|---|---|---|---|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 1.48 | 21.1 years STANDARD_DEVIATION 1.64 | 2 years STANDARD_DEVIATION 0 | 1.5 years STANDARD_DEVIATION 0.187 | 1 years STANDARD_DEVIATION 0 | 20 years STANDARD_DEVIATION 13.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 73 Participants | 1 Participants | 6 Participants | 2 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 20 Participants | 0 Participants | 0 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 12 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 42 Participants | 0 Participants | 6 Participants | 0 Participants | 10 Participants |
| Region of Enrollment United States | 47 participants | 77 participants | 1 participants | 6 participants | 2 participants | 21 participants |
| Sex: Female, Male Female | 30 Participants | 44 Participants | 0 Participants | 3 Participants | 0 Participants | 11 Participants |
| Sex: Female, Male Male | 17 Participants | 33 Participants | 1 Participants | 3 Participants | 2 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 7 | 0 / 2 | 0 / 25 | 0 / 56 |
| other Total, other adverse events | 0 / 1 | 1 / 7 | 0 / 2 | 7 / 25 | 4 / 56 |
| serious Total, serious adverse events | 0 / 1 | 0 / 7 | 0 / 2 | 0 / 25 | 0 / 56 |
Outcome results
Count of Participants From Each Arm Who Received Influenza Vaccine
Time frame: Day 0 to 28-32 post immunization
Population: Participants with available data at the respective timepoint are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A: 2-4 yo LAIV4 (Return) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2014-2015 | 1 Participants |
| Group D: 6 - 23 Mos Old IIV4 (Returning) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2014-2015 | 3 Participants |
| Group D: 6 - 23 Mos Old IIV4 (Returning) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2017-2018 | 5 Participants |
| Group D: 6 - 23 Mos Old IIV4 (Returning) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2015-2016 | 6 Participants |
| Group D: 6 - 23 Mos Old IIV4 (Returning) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2016-2017 | 4 Participants |
| Group E: 6 - 23 Mos Old IIV4 (Single Yr) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2016-2017 | 2 Participants |
| Group F: 9-13/18-49 yo LAIV4 (Single Yr) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2015-2016 | 14 Participants |
| Group F: 9-13/18-49 yo LAIV4 (Single Yr) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2014-2015 | 11 Participants |
| Group G: 9-13/18-49 yo IIV4 (Single Yr) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2017-2018 | 5 Participants |
| Group G: 9-13/18-49 yo IIV4 (Single Yr) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2014-2015 | 13 Participants |
| Group G: 9-13/18-49 yo IIV4 (Single Yr) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2015-2016 | 20 Participants |
| Group G: 9-13/18-49 yo IIV4 (Single Yr) | Count of Participants From Each Arm Who Received Influenza Vaccine | 2016-2017 | 18 Participants |
Count of Participants With Related Adverse Events
Time frame: Day 0 to 28-32 post-immunization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: 2-4 yo LAIV4 (Return) | Count of Participants With Related Adverse Events | 0 Participants |
| Group D: 6 - 23 Mos Old IIV4 (Returning) | Count of Participants With Related Adverse Events | 1 Participants |
| Group E: 6 - 23 Mos Old IIV4 (Single Yr) | Count of Participants With Related Adverse Events | 0 Participants |
| Group F: 9-13/18-49 yo LAIV4 (Single Yr) | Count of Participants With Related Adverse Events | 7 Participants |
| Group G: 9-13/18-49 yo IIV4 (Single Yr) | Count of Participants With Related Adverse Events | 4 Participants |