U19 Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza. Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire- Year 1, 2009
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Stanford University
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Number of Participants From Each Arm Who Received Influenza Vaccine
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is an exploratory study using a strategy that has not been previously employed to investigate the effects of age and vaccine type on specific kinds of immune responses to licensed, seasonal 2009-2010 influenza vaccines in children and adults.
Detailed Description
This study is being conducted in healthy male and female volunteers. 8-17 year-old identical twins will be randomly assigned to receive a single administration of the 2009-2010 formulation of either seasonal trivalent inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV). Twins within a pair will receive different vaccines. 18-30 year-old and 70-100 year-old subjects will receive a single administration of the 2009-2010 formulation of TIV. Blood samples to conduct the assays will be taken at pre-immunization, Day 7-8 and Day 28 post immunization.
Investigators
Cornelia L. Dekker
Professor, Pediatrics
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Otherwise healthy, ambulatory children 8-17 year-old twins, adults 18-30 years old (non-twin) or 70-100 year-old elderly non-twin adults.
- •Willing to complete the informed consent process.
- •Availability for follow-up for the planned duration of the study at least 28 days after immunization.
- •Acceptable medical history by medical history and vital signs.
Exclusion Criteria
- •Prior off-study vaccination with the current seasonal TIV or LAIV in Fall 2009
- •Allergy to egg or egg products, or to vaccine components, including gentamicin, gelatin, arginine or MSG (for LAIV only), or thimerosal (TIV multidose vials only).
- •Life-threatening reactions to previous influenza vaccinations
- •Asthma or history of wheezing (for volunteers randomized to LAIV)
- •Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- •History of immunodeficiency (including HIV infection)
- •Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- •Blood pressure \>150 systolic or \>95 diastolic at first study visit
- •Hospitalization in the past year for congestive heart failure or emphysema.
- •Chronic Hepatitis B or C.
Outcomes
Primary Outcomes
Number of Participants From Each Arm Who Received Influenza Vaccine
Time Frame: Day 0 to 28
Secondary Outcomes
- Number of Participants With Related Adverse Events(Day 0 to 28 post-immunization)