Immune Responses Induced by Different Licensed Influenza Vaccines
Immune Response Induced by Different Manufacturers of Influenza Vaccines
1 other identifier
interventional
193
1 country
1
Brief Summary
The goal of this research is to find out how the body's immune system responds to different manufacturer's "flu" vaccines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 13, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
November 20, 2017
CompletedNovember 20, 2017
June 1, 2017
7.5 years
May 13, 2009
June 1, 2017
October 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
T Cell Responses Following Immunization
Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups
Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination
Secondary Outcomes (1)
Antibody Responses Following Immunization
Prevaccination and approximately 1 month post vaccination
Study Arms (5)
Flulaval
ACTIVE COMPARATORFluvirin
ACTIVE COMPARATORFluzone
ACTIVE COMPARATORFluarix
ACTIVE COMPARATORAffluria
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adults (18-50 years of age)
- Willing to donate a blood sample multiple times
- Willing to sign informed consent and HIPAA
You may not qualify if:
- Known systemic hypersensitivity reactions to egg proteins (eggs or egg products), to chicken proteins
- Known hypersensitivity to neomycin, thimerosol (mercury derivative), neomycin, or polymyxin
- Previous life threatening reaction to influenza vaccine
- Individuals with altered immunocompetence state from medical condition ( HIV, cancer) or through immunosuppressive therapy(irradiation,corticosteroids, antimetabolites, alkylating agents, cytotoxic agents)
- Occurrence of neurological syndrome within six weeks of previous influenza immunization
- Active neurological disorder characterized by changing neurological disorder
- Pregnancy
- Acute febrile illness
- History of anemia or bleeding disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Massachusetts Medical School
Worcester, Massachusetts, 01605, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mary Co
- Organization
- University of Massachusetts Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Dawn T Co, MD
University of Massachusetts, Worcester
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principle Investigator
Study Record Dates
First Submitted
May 13, 2009
First Posted
May 15, 2009
Study Start
October 1, 2008
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
November 20, 2017
Results First Posted
November 20, 2017
Record last verified: 2017-06