Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138281
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2005-08-26
Brief Title:
Influenza Immunity Against Pandemic Respiratory Virus
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Influenza Immunity Protective Mechanisms Against a Pandemic Respiratory Virus
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sixty adults ages 18-49 will be randomly assigned to receive either FluMist or Fluzone Some of the subjects will have participated in previous studies for these 2 vaccines The study will last 4 months with subject participation being 28 days The purpose of this study is to measure immune response to the vaccinations
Detailed Description:
This is a Phase 4 single-center study of the immune responses of adults to one of two licensed influenza vaccines either inactivated vaccine given IM or live attenuated vaccine given intranasally The study will enroll up to 60 adults ages 18-49 some of whom were immunized in the Years 1 and 2 studies This study began Year 1 of this grant with a protocol testing the two vaccine products in their age-approved populations FluMist is approved for use in healthy children and adolescents 5-17 years of age and healthy adults 18-49 years of age Fluzone is approved for all age groups starting at 6 months of age To match for age and to study the youngest children possible the age cohorts of 5-9 and 18-49 years were chosen for initial Year 1 study In 2003 70 adults and 16 children were enrolled randomized 11 to receive either FluMist or Fluzone and immunized In 2004 44 of the original 70 adults were re-immunized with the same preparation they received in 2003 In addition studies were conducted in twenty-eight 6mos to 5yo children who all received Fluzone and in thirty-nine 5-9 yo children who were randomized 11 to receive either FluMist or Fluzone For 2005 we propose to study in this protocol adults from last year who agree to a third immunization plus as many new adults to add up to a total of 60 Blood samples will also be taken at Days 0 7-9 and 28 to be analyzed for CD4 and CD8 T-cell B-cell NK-cell and homing receptor responses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None