NCT03328325

Age and Response to Flu Vaccines

Evaluation of the Effects of Age, Prior Exposure, and Previous Vaccination on the B Cell Response to Inactivated Influenza Vaccine in Healthy Adults and Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 9 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration will be 5 years, with a participant duration of 6 months. Subjects will receive a quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at baseline, day 7, 28 and 90. The primary objective of this study is to evaluate the relationship between first influenza A virus exposure (inferred by age), vaccine history, and baseline serum antibody response to seasonal influenza vaccine in healthy adults and children.

Detailed description

The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration will be 5 years, with a participant duration of 6 months. Subjects will receive a quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at baseline, day 7, 28 and 90. The primary hypothesis being tested in this study is that there will be differences in the specificity and magnitude of the HA-specific B cell response depending on the age, previous vaccine history and baseline B cell reactivity. The primary objective of this study is to evaluate the relationship between first influenza A virus exposure (inferred by age), vaccine history, and baseline serum antibody response to seasonal influenza vaccine in healthy adults and children. The secondary objective is to evaluate factors related to failure of vaccine to provide protection against symptomatic influenza and the immune response to infection in vaccinated individuals by prospective surveillance of the vaccine cohort.

Conditions

• Influenza
• Influenza Immunisation

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Virus Quadrivalent Inactivated Vaccine	A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
BIOLOGICAL	Influenza Virus Quadrivalent Inactivated Vaccine	A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.

Timeline

• Start date: 2017-12-14
• Primary completion: 2020-02-09
• Completion: 2020-04-20
• First posted: 2017-11-01
• Last updated: 2021-05-24
• Results posted: 2021-05-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study