Age and Response to Flu Vaccines
Age and Response to Flu Vaccines
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.
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.
Inclusion Criteria:

 1. Aged equal to or greater than 9 years of age and weigh at least 50 pounds

 2. The subject must be in good health, as determined by: medical history; and targeted
 physical examination, when necessary, based on medical history. Stable medical or
 psychiatric condition is defined as: no recent increase in prescription medication,
 dose, or frequency of medication in the last 3 months and health outcomes of the
 specific disease are considered to be within acceptable limits in the last 6 months

 3. The subject is able to understand and comply with the planned study procedures,
 including being available for all study visits

 4. The subject/parent has provided informed consent/assent prior to any study procedures

 5. Subjects who have not received seasonal flu vaccine for the current year

 Exclusion Criteria:

 1. Subject report of known hypersensitivity to allergy to components of the study vaccine
 or other components of the study vaccine

 2. Subject report of known latex allergy

 3. Subject report of a history of severe reactions following previous immunization with
 licensed or unlicensed influenza virus vaccines

 4. Subject report of a history of Guillain-Barre syndrome within 6 weeks of receipt of a
 previous influenza vaccine

 5. The subject is a female of childbearing potential who is currently pregnant or
 breastfeeding or intends to become pregnant during the study period between enrollment
 and 90 days following receipt of vaccine. Pregnancy will be determined by subject
 interview. Pregnancy testing is not done in this study since there is no increased
 risk in pregnancy

 6. The subject is immunosuppressed as a result of an underlying illness or treatment with
 immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation
 therapy within the preceding 36 months

 7. The subject has an active neoplastic disease (excluding non-melanoma skin cancer or
 prostate cancer that is stable in the absence of therapy) or a history of any
 hematological malignancy. For this criterion, "active" is defined as having received
 treatment within the past 5 years

 8. Have taken high-dose inhaled corticosteroids within 30 days prior to study
 vaccination. High-dose defined as per age as using inhaled high dose per reference
 chart
 https://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines/quick-refere
 nce-html#estimated-comparative-daily-doses

 9. The subject received immunoglobulin or another blood product within the 3 months prior
 to enrollment in this study

 10. The subject has received an inactivated vaccine within the 2 weeks or a live vaccine
 within the 4 weeks prior to enrollment in this study or plans to receive another
 vaccine within the next 28 days after vaccination

 11. The subject has an acute or chronic medical condition that, in the opinion of the
 investigator or appropriate sub-investigator, would render vaccination unsafe or would
 interfere with the evaluation of responses. These conditions include any acute or
 chronic medical disease or conditions defined as persisting for 3 months (defined as
 90 days) or longer, that would place the subject at an unacceptable risk of injury,
 render the subject unable to meet the requirements of the protocol, or may interfere
 with the evaluation of responses of the subject's successful completion of the study

 12. Subjects with an active infection or that has an acute illness or an oral temperature
 greater than 99.9 degrees Fahrenheit (37.7 degrees Celsius) within 3 days prior to
 enrollment or vaccination. Subjects who had an acute illness that was treated symptoms
 resolved are eligible to enroll as long as treatment is completed and symptoms
 resolved > 3 days prior to enrollment

 13. The subject is currently participating or plans to participate in a study that
 involves an experimental agent (vaccine, drug, biologic, device, blood product, or
 medication) or has received an experimental agent within 1 month prior to enrollment
 in this study, or expects to receive another experimental agent during participation
 in this study, or intends to donate blood during the study period

 14. The subject has any condition that would, in the opinion of the site investigator,
 place the subject at an unacceptable risk of injury or render the subject unable to
 meet the requirements of the protocol

 15. The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment

 16. The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C
 infection

 17. Subject weighs less than 50 lbs

 18. Subject expects to have a medical procedure during the upcoming 8 weeks that estimates
 blood loss to exceed 400 cc for adults or for children would exceed 3 ml/kg