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Innate and Acquired Immunity to Influenza Infection and Immunization (SLVP029)

Adaptive and Innate Immunity, Memory and Repertoire in Vaccination and Infection

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03028974
Enrollment
77
Registered
2017-01-23
Start date
2014-09-17
Completion date
2017-11-20
Last updated
2018-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

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

BIOLOGICALFluzone®

Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine

BIOLOGICALFluMist®

FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Stanford University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 49 Years
Healthy volunteers
Yes

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

MeasureTime frame
Count of Participants From Each Arm Who Received Influenza VaccineDay 0 to 28-32 post immunization

Secondary

MeasureTime frame
Count of Participants With Related Adverse EventsDay 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

ArmCount
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
Total77

Baseline characteristics

CharacteristicGroup G: 9-13/18-49 yo IIV4 (Single Yr)TotalGroup 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, Continuous33.5 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 Participants3 Participants0 Participants0 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
45 Participants73 Participants1 Participants6 Participants2 Participants19 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
12 Participants20 Participants0 Participants0 Participants2 Participants6 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
8 Participants12 Participants1 Participants0 Participants0 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
White
26 Participants42 Participants0 Participants6 Participants0 Participants10 Participants
Region of Enrollment
United States
47 participants77 participants1 participants6 participants2 participants21 participants
Sex: Female, Male
Female
30 Participants44 Participants0 Participants3 Participants0 Participants11 Participants
Sex: Female, Male
Male
17 Participants33 Participants1 Participants3 Participants2 Participants10 Participants

Adverse events

Event typeEG000
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 / 10 / 70 / 20 / 250 / 56
other
Total, other adverse events
0 / 11 / 70 / 27 / 254 / 56
serious
Total, serious adverse events
0 / 10 / 70 / 20 / 250 / 56

Outcome results

Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group A: 2-4 yo LAIV4 (Return)Count of Participants From Each Arm Who Received Influenza Vaccine2014-20151 Participants
Group D: 6 - 23 Mos Old IIV4 (Returning)Count of Participants From Each Arm Who Received Influenza Vaccine2014-20153 Participants
Group D: 6 - 23 Mos Old IIV4 (Returning)Count of Participants From Each Arm Who Received Influenza Vaccine2017-20185 Participants
Group D: 6 - 23 Mos Old IIV4 (Returning)Count of Participants From Each Arm Who Received Influenza Vaccine2015-20166 Participants
Group D: 6 - 23 Mos Old IIV4 (Returning)Count of Participants From Each Arm Who Received Influenza Vaccine2016-20174 Participants
Group E: 6 - 23 Mos Old IIV4 (Single Yr)Count of Participants From Each Arm Who Received Influenza Vaccine2016-20172 Participants
Group F: 9-13/18-49 yo LAIV4 (Single Yr)Count of Participants From Each Arm Who Received Influenza Vaccine2015-201614 Participants
Group F: 9-13/18-49 yo LAIV4 (Single Yr)Count of Participants From Each Arm Who Received Influenza Vaccine2014-201511 Participants
Group G: 9-13/18-49 yo IIV4 (Single Yr)Count of Participants From Each Arm Who Received Influenza Vaccine2017-20185 Participants
Group G: 9-13/18-49 yo IIV4 (Single Yr)Count of Participants From Each Arm Who Received Influenza Vaccine2014-201513 Participants
Group G: 9-13/18-49 yo IIV4 (Single Yr)Count of Participants From Each Arm Who Received Influenza Vaccine2015-201620 Participants
Group G: 9-13/18-49 yo IIV4 (Single Yr)Count of Participants From Each Arm Who Received Influenza Vaccine2016-201718 Participants
Secondary

Count of Participants With Related Adverse Events

Time frame: Day 0 to 28-32 post-immunization

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group A: 2-4 yo LAIV4 (Return)Count of Participants With Related Adverse Events0 Participants
Group D: 6 - 23 Mos Old IIV4 (Returning)Count of Participants With Related Adverse Events1 Participants
Group E: 6 - 23 Mos Old IIV4 (Single Yr)Count of Participants With Related Adverse Events0 Participants
Group F: 9-13/18-49 yo LAIV4 (Single Yr)Count of Participants With Related Adverse Events7 Participants
Group G: 9-13/18-49 yo IIV4 (Single Yr)Count of Participants With Related Adverse Events4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026