Age and Response to Flu Vaccines
Condition: Influenza; Influenza Immunisation
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Influenza Virus Quadrivalent Inactivated Vaccine; Influenza Virus Quadrivalent Inactivated Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 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.; 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.
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: B Cell Response; Children; Evaluation; Healthy Adults; Influenza Vaccine