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Protocol Details

Natural History of Systemic and Nasal Mucosal Immunity after Influenza Vaccination in a Pediatric Population

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 2 Years
Max Age: 17 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;
Non-English Speaking


Flu Shot;
Natural History

Recruitment Keyword(s)



Influenza immunity

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Allergy and Infectious Diseases


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.


To learn what happens in kids immune systems after receiving a flu vaccine.


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.


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.

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In order to be eligible to enroll in this study, an individual must meet all of the following criteria:

- >= 2 years of age and < 18 years of age at the time of enrollment.

- Completed a previous influenza series in the past and therefore requires only one seasonal influenza vaccine every year.

- Planning to receive the current seasonal inactivated influenza vaccine given by injection.

- Parent or guardian willing and able to provide verbal consent.

- Willing and able to undergo home blood micro-sampling and nasal sampling.

- Willing to have samples stored for future research.

- Parent/guardian able to proficiently speak, read, and write English.


Any individual who meets any of the following criteria will be excluded from participation in this study:

- Already received the current season s influenza vaccine.

- Planning to receive the current seasonal live attenuated influenza vaccine (LAIV).

- Self-reported pregnancy or breastfeeding.

- Any condition that, in the opinion of the investigator, would compromise the safety of the study participant or staff, or would prevent proper conduct of the study.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Alison Han, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CRC BG RM 4-2571
(301) 496-2209

Rani S. Athota, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 15F1
Room 100
9000 Rockville Pike
Bethesda, Maryland 20892
(301) 594-0803

Rani S. Athota, Ph.D.
National Institutes of Health
Building 15F1
Room 100
9000 Rockville Pike
Bethesda, Maryland 20892
(301) 594-0803

Clinical Trials Number:


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