Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-01 @ 6:09 PM
Study NCT ID:
NCT04963166
Status:
COMPLETED
Last Update Posted:
2025-10-09
First Post:
2021-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural History of Systemic and Nasal Mucosal Immunity After Influenza Vaccination in a Pediatric Population
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Natural History of Systemic and Nasal Mucosal Immunity After Influenza Vaccination in a Pediatric Population
Status:
COMPLETED
Status Verified Date:
2025-09-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background:
The influenza (flu) virus infects millions around the world every year. Children are at increased risk of complications from the flu. The flu vaccine protects against influenza, but the vaccine can be improved. Researchers want to learn more about children s mucosal and systemic immunity after flu vaccination. This could help to develop more effective flu vaccines in the future.
Objective:
To learn what happens in kids immune systems after receiving a flu vaccine.
Eligibility:
Children ages 2-17 who have received a flu vaccine in the past and plan to get the current seasonal flu vaccine given by injection.
Design:
All study visits will take place at home and communication with the study team will be done via phone or videoconference.
Participants will review medical history and flu vaccination history with the study team.
Participants will get the flu vaccine at their local doctor s office or pharmacy. They will not be given the vaccine in this study.
Participants will complete an electronic survey to give details about the date and type of flu vaccine received.
Participants will collect nasal and fingerstick samples at home. They will collect 4 nasal samples and 3 fingerstick samples over 6 months: once before they get the flu vaccine and 2-3 times after they get the vaccine. They will use collection kits that include instructions, sample collection supplies, and shipping materials. They will ship all samples back to NIH with all costs covered by NIH.
Participation will last for 6 months.
Compensation is provided.
The influenza (flu) virus infects millions around the world every year. Children are at increased risk of complications from the flu. The flu vaccine protects against influenza, but the vaccine can be improved. Researchers want to learn more about children s mucosal and systemic immunity after flu vaccination. This could help to develop more effective flu vaccines in the future.
Objective:
To learn what happens in kids immune systems after receiving a flu vaccine.
Eligibility:
Children ages 2-17 who have received a flu vaccine in the past and plan to get the current seasonal flu vaccine given by injection.
Design:
All study visits will take place at home and communication with the study team will be done via phone or videoconference.
Participants will review medical history and flu vaccination history with the study team.
Participants will get the flu vaccine at their local doctor s office or pharmacy. They will not be given the vaccine in this study.
Participants will complete an electronic survey to give details about the date and type of flu vaccine received.
Participants will collect nasal and fingerstick samples at home. They will collect 4 nasal samples and 3 fingerstick samples over 6 months: once before they get the flu vaccine and 2-3 times after they get the vaccine. They will use collection kits that include instructions, sample collection supplies, and shipping materials. They will ship all samples back to NIH with all costs covered by NIH.
Participation will last for 6 months.
Compensation is provided.
Detailed Description:
Title:
Natural History of Systemic and Nasal Mucosal Immunity after Influenza Vaccination in a Pediatric Population
Study Description:
While adults are heavily represented in influenza vaccine studies, there are limited studies in the pediatric population. This study will characterize the changes in nasal and systemic immunity after influenza vaccination in a pediatric population.
Objectives:
Primary Objectives:
Characterize nasal mucosal humoral immune response pre and post influenza vaccination
Characterize systemic humoral immune response pre and post influenza vaccination
Secondary Objectives:
Describe the trend of nasal mucosal mucosal and serum humoral immune response over time after vaccination
Endpoints:
Primary Endpoints:
1. Baseline and post-vaccination mucosal anti-influenza antibodies from nasal samples as measured by:
1. Anti-hemagglutination (HA) head antibody quantitative enzyme-linked immunosorbent assay (ELISA) immunoglobulins (Ig) (IgA, IgG)
2. Anti-HA stalk antibody quantitative ELISA (IgA, IgG)
3. Anti-neuraminidase (NA) antibody quantitative ELISA (IgA, IgG)
2. Baseline and post-vaccination systemic anti-influenza antibodies as measured by:
1. Anti-HA head antibody quantitative ELISA (IgM, IgG, IgA)
2. Anti-HA stalk antibody quantitative ELISA (IgM, IgG, IgA)
3. Anti-NA antibody quantitative ELISA (IgM, IgG, IgA)
Secondary Endpoints:
Multiple timepoint measurements of mucosal anti-influenza antibodies from nasal samples as measured by:
Anti-HA head antibody quantitative ELISA (IgA, IgG)
Anti-HA stalk antibody quantitative ELISA (IgA, IgG)
Anti-NA antibody quantitative ELISA (IgA, IgG)
Multiple timepoint measurements of systemic anti-influenza antibodies as measured by:
Anti-HA head antibody quantitative ELISA (IgM, IgG, IgA)
Anti-HA stalk antibody quantitative ELISA (IgM, IgG, IgA)
Anti-NA antibody quantitative ELISA (IgM, IgG, IgA)
Study Population:
Children who are \>= 2 years and \< 18 years of age (N = 51; accrual ceiling = 100). Participants will be enrolled by age group: 2 - 6 years old, 7 - 11 years old and 12 - 17 years old with a goal enrollment of 17 per group.
Description of Sites/Facilities Enrolling Participants:
Participants will be enrolled by telephone or videoconference, and sample collections will be done in participant homes. Recruitment will be from community pediatric clinics and self- or family referral.
Study Duration:
2 years
Natural History of Systemic and Nasal Mucosal Immunity after Influenza Vaccination in a Pediatric Population
Study Description:
While adults are heavily represented in influenza vaccine studies, there are limited studies in the pediatric population. This study will characterize the changes in nasal and systemic immunity after influenza vaccination in a pediatric population.
Objectives:
Primary Objectives:
Characterize nasal mucosal humoral immune response pre and post influenza vaccination
Characterize systemic humoral immune response pre and post influenza vaccination
Secondary Objectives:
Describe the trend of nasal mucosal mucosal and serum humoral immune response over time after vaccination
Endpoints:
Primary Endpoints:
1. Baseline and post-vaccination mucosal anti-influenza antibodies from nasal samples as measured by:
1. Anti-hemagglutination (HA) head antibody quantitative enzyme-linked immunosorbent assay (ELISA) immunoglobulins (Ig) (IgA, IgG)
2. Anti-HA stalk antibody quantitative ELISA (IgA, IgG)
3. Anti-neuraminidase (NA) antibody quantitative ELISA (IgA, IgG)
2. Baseline and post-vaccination systemic anti-influenza antibodies as measured by:
1. Anti-HA head antibody quantitative ELISA (IgM, IgG, IgA)
2. Anti-HA stalk antibody quantitative ELISA (IgM, IgG, IgA)
3. Anti-NA antibody quantitative ELISA (IgM, IgG, IgA)
Secondary Endpoints:
Multiple timepoint measurements of mucosal anti-influenza antibodies from nasal samples as measured by:
Anti-HA head antibody quantitative ELISA (IgA, IgG)
Anti-HA stalk antibody quantitative ELISA (IgA, IgG)
Anti-NA antibody quantitative ELISA (IgA, IgG)
Multiple timepoint measurements of systemic anti-influenza antibodies as measured by:
Anti-HA head antibody quantitative ELISA (IgM, IgG, IgA)
Anti-HA stalk antibody quantitative ELISA (IgM, IgG, IgA)
Anti-NA antibody quantitative ELISA (IgM, IgG, IgA)
Study Population:
Children who are \>= 2 years and \< 18 years of age (N = 51; accrual ceiling = 100). Participants will be enrolled by age group: 2 - 6 years old, 7 - 11 years old and 12 - 17 years old with a goal enrollment of 17 per group.
Description of Sites/Facilities Enrolling Participants:
Participants will be enrolled by telephone or videoconference, and sample collections will be done in participant homes. Recruitment will be from community pediatric clinics and self- or family referral.
Study Duration:
2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 000488-I | None | None | View |