Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133523
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2005-08-19
Brief Title:
FLU-VACS Comparative Study in Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Comparative Study of Influenza Vaccines in Adults - FLU-VACS
Status:
COMPLETED
Status Verified Date:
2009-10
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:
The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo inactive substance The study will be conducted among healthy adult participants aged 18-49 years and is expected to last 3 years During year 1 participants will be assigned to receive 1 of the 2 licensed flu vaccines or placebo given as either nasal spray live-attenuated vaccine or placebo or injection inactivated vaccine or placebo Participants will receive the same assigned vaccine or placebo during year 2 During year 3 participants will be followed but will not receive flu vaccine Each year blood samples will be collected before and 1 month after each vaccination and at the end of each flu season in order to measure how the body responds to the vaccine and how well participants were protected from the flu During the flu season participants with flu-like illness will provide information on symptoms and provide a throat swab to test for virus identification
Detailed Description:
Influenza occurs on an annual basis producing significant mortality in most years mainly in those with underlying conditions and those at extremes of age This study is a placebo-controlled trial to examine efficacies of the live attenuated and inactivated influenza vaccines and immune correlates of protection the study will take place in Michigan over a three year period and will target adults aged 18-49 years Both vaccine preparations are licensed for this age group In the first year participants will be randomly assigned to receive one of the two licensed vaccines or placebo In the second year participant receipt of vaccine updated according to national recommendations or placebo will continue as assigned in the first year for returning participants and new enrollees will be randomly assigned to intervention In the third year when duration of immunity will be evaluated no interventions will be given In all study years blood specimens for serologic studies and specimens for virus identification will be collected and a number of laboratory studies will be performed so that it will be possible to achieve the studys objectives The primary annual study outcome for efficacy is the proportion of subjects with laboratory-confirmed symptomatic influenza A or B illness defined as influenza virus isolated in tissue culture from a throat swab obtained from a participant during an episode of illness meeting the influenza case definition that is confirmed as influenza by fluorescent antibody or polymerase chain reaction PCR techniques or serologic confirmation of influenza infection in a participant with an episode of illness meeting the influenza case definition specifically a 4-fold rise in hemagglutinin inhibition assay HAI antibody titer to a circulating influenza strain between post-vaccination pre-season and post-season paired sera The influenza case definition is illness with at least one respiratory symptom cough or nasal congestion and at least one constitutional symptom fever or feverishness chills or body aches Subjects will be evaluated for serious adverse events throughout each annual study period Annually the proportion of participants with local reactions during the first seven days or any adverse reactions during the first thirty days after vaccine receipt will be compared with recipients of placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRBMed 2004-0334 | None | None | None |