Age and Response to Flu Vaccines
Condition: Influenza; Influenza Immunisation
MeSH terms: Influenza, Human
Intervention: Influenza Virus Quadrivalent Inactivated Vaccine; Influenza Virus Quadrivalent Inactivated Vaccine
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: B Cell Response; Children; Evaluation; Healthy Adults; Influenza Vaccine

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.
    

Eligibility criteria:

        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