Influenza Clinical Trial
Official title:
Adaptive and Innate Immunity, Memory and Repertoire in Vaccination and Infection
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
| Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
| Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
| Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
| Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
| Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
| Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
| Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
| Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
| Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
| Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
| Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
| Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
| Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
| Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
| Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
| Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
| Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |