drugset / Trial / NCT03328325

Age and Response to Flu Vaccines

NCT03328325

NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2017-12-14
Primary completion
2020-02-09
Completion
2020-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza Virus Quadrivalent Inactivated Vaccine Vaccine 15 ug Intramuscular
Subject Influenza Virus Quadrivalent Inactivated Vaccine Vaccine 0.5 ml Intramuscular

Indications