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RECRUITINGPhase 4INTERVENTIONAL

B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study will examine how various FDA-approved seasonal influenza vaccine types, used in a manner consistent with their approved use, impact the characteristics of influenza specific antibodies in humans, and how these responses differ based on age and prior immunization history.

Who May Be Eligible (Plain English)

Who May Qualify: - Participation in ancillary clinical research study - Able to give willing to sign a consent form - Age 18-50 years old for Arm 1 and Arm 2 - Age 65-80 years old for Arm 3, Arm 4, and Arm 5 - Weight of at least 110 lbs as determined by self-reporting Who Should NOT Join This Trial: - Inability to give willing to sign a consent form - Refusal or inability to have blood drawn or participate in study procedures - Previous adverse reaction to influenza vaccine or medical history contraindicated for receiving influenza vaccine, including but not limited to: 1. History of Guillain-Barre Syndrome 2. History of egg allergy 3. History of gelatin allergy 4. History of moderate to severe illness with or without fever within 6 weeks of receipt of influenza vaccine - Previous receipt of influenza vaccine outside of study within current season - Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) - Participant has any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgement of the investigator would interfere with, or serve as a contraindication to the planned procedure(s). - These following criteria are used for scientific reasons, and not safety reasons. Specifically, the criteria are used to obtain a population that is healthy and less likely to have conditions that may influence the immune system: 1. No recent respiratory infections in the past 4 weeks at time of vaccination 2. Malignancy 3. Evidence of Inflammation: Systemic Lupus Erythematosis, Rheumatoid Arthritis, Polymyositis, Dermatomyositis, Scleroderma, Crohn's Disease, Ulcerative Colitis. 4. Lymphoproliferative Disorder 5. Known weakened immune system 6. Myocardial Infarction \<6 months 7. Cerebral Vascular Accident 8. Peripheral Vascular Disease- recannulation \<6months 9. Cardiac Insufficiency - congestive heart failure ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Participation in ancillary clinical research study * Able to give informed consent * Age 18-50 years old for Arm 1 and Arm 2 * Age 65-80 years old for Arm 3, Arm 4, and Arm 5 * Weight of at least 110 lbs as determined by self-reporting Exclusion Criteria: * Inability to give informed consent * Refusal or inability to have blood drawn or participate in study procedures * Previous adverse reaction to influenza vaccine or medical history contraindicated for receiving influenza vaccine, including but not limited to: 1. History of Guillain-Barre Syndrome 2. History of egg allergy 3. History of gelatin allergy 4. History of moderate to severe illness with or without fever within 6 weeks of receipt of influenza vaccine * Previous receipt of influenza vaccine outside of study within current season * Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) * Participant has any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgement of the investigator would interfere with, or serve as a contraindication to the planned procedure(s). * These following criteria are used for scientific reasons, and not safety reasons. Specifically, the criteria are used to obtain a population that is healthy and less likely to have conditions that may influence the immune system: 1. No recent respiratory infections in the past 4 weeks at time of vaccination 2. Malignancy 3. Evidence of Inflammation: Systemic Lupus Erythematosis, Rheumatoid Arthritis, Polymyositis, Dermatomyositis, Scleroderma, Crohn's Disease, Ulcerative Colitis. 4. Lymphoproliferative Disorder 5. Known Immunodeficiency 6. Myocardial Infarction \<6 months 7. Cerebral Vascular Accident 8. Peripheral Vascular Disease- recannulation \<6months 9. Cardiac Insufficiency - congestive heart failure 10. Hypertension with increased blood urea nitrogen (BUN) 11. Renal Failure 12. Dementia 13. Alcoholism (defined as \>17 drinks/week) 14. Drug Abuse (excluding marijuana) 15. HIV positive 16. History of hepatitis 17. History of immunization within 4 weeks of study participation or plan to receive non- IIV vaccination within 4 weeks of receiving IIV 18. Moderate to severe illness at time of enrollment * Donations of blood in the 8 weeks prior to enrollment which, combined with expected volumes to be drawn for this study, would exceed 450 mL in an 8 week period. * Current pregnancy at time of enrollment or pregnancy within last 4 months * Active or planned breastfeeding during study participation * Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.

Treatments Being Tested

DRUG

Fluzone

inactivated seasonal influenza vaccine

DRUG

Flucelvax

inactivated seasonal influenza vaccine

DRUG

Fluzone High-Dose

inactivated seasonal influenza vaccine

DRUG

Fluad

inactivated seasonal influenza vaccine

Locations (1)

University of Alabama at Birmingham
Birmingham, Alabama, United States