Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Cell-Derived Trivalent Subunit Influenza Vaccine in Subjects Aged >= 18 Years and <= 64 Years During Two Consecutive Years.
1 other identifier
interventional
1,270
1 country
15
Brief Summary
Immunogenicity and safety of a cell-derived influenza vaccine in adults aged \>= 18 and \<= 64 years, plus revaccination
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2009
15 active sites
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
First Submitted
Initial submission to the registry
April 28, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedOctober 25, 2013
September 1, 2013
1.7 years
April 28, 2009
September 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.
3 weeks
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.
6 months
Secondary Outcomes (3)
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
6 months
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.
3 weeks
To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.
6 months
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
surface antigen, inactivated, prepared in cell cultures
Eligibility Criteria
You may qualify if:
- Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- Men and women aged \>= 18 and \<= 64 years.
- Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
You may not qualify if:
- Known to be allergic to constituents of the vaccine.
- Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Biologicalslead
- Quintiles, Inc.collaborator
Study Sites (15)
Site Reference ID/Investigator# 45690
Jacksonville, Florida, 32216, United States
Site Reference ID/Investigator# 45687
Pembroke Pines, Florida, 33024, United States
Site Reference ID/Investigator# 45697
South Miami, Florida, 33143, United States
Site Reference ID/Investigator# 45691
Lenexa, Kansas, 66219, United States
Site Reference ID/Investigator# 45689
Overland Park, Kansas, 66212, United States
Site Reference ID/Investigator# 45694
Wichita, Kansas, 67207, United States
Site Reference ID/Investigator# 45682
Lexington, Kentucky, 40509, United States
Site Reference ID/Investigator# 45684
Kansas City, Missouri, 64114, United States
Site Reference ID/Investigator# 45685
Omaha, Nebraska, 68134, United States
Site Reference ID/Investigator# 45686
Las Vegas, Nevada, 89104, United States
Site Reference ID/Investigator# 45688
Raleigh, North Carolina, 27612, United States
Site Reference ID/Investigator# 45696
Nashville, Tennessee, 37203, United States
Site Reference ID/Investigator# 45683
Austin, Texas, 78705, United States
Site Reference ID/Investigator# 45695
Fort Worth, Texas, 76135, United States
Site Reference ID/Investigator# 45692
Salt Lake City, Utah, 84124, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hanka de Voogd, MD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2009
First Posted
April 29, 2009
Study Start
May 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
October 25, 2013
Record last verified: 2013-09