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Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cell-Derived Trivalent Subunit Influenza Vaccine
Placebo
Sponsored by
Abbott Biologicals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Phase II, Placebo-controlled

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
  2. Men and women aged >= 18 and <= 64 years.
  3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria

  1. Known to be allergic to constituents of the vaccine.
  2. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
  3. Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.

Sites / Locations

  • Site Reference ID/Investigator# 45690
  • Site Reference ID/Investigator# 45687
  • Site Reference ID/Investigator# 45697
  • Site Reference ID/Investigator# 45691
  • Site Reference ID/Investigator# 45689
  • Site Reference ID/Investigator# 45694
  • Site Reference ID/Investigator# 45682
  • Site Reference ID/Investigator# 45684
  • Site Reference ID/Investigator# 45685
  • Site Reference ID/Investigator# 45686
  • Site Reference ID/Investigator# 45688
  • Site Reference ID/Investigator# 45696
  • Site Reference ID/Investigator# 45683
  • Site Reference ID/Investigator# 45695
  • Site Reference ID/Investigator# 45692

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.

Secondary Outcome Measures

To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.
To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.

Full Information

First Posted
April 28, 2009
Last Updated
September 27, 2013
Sponsor
Abbott Biologicals
Collaborators
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00889889
Brief Title
Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Biologicals
Collaborators
Quintiles, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Phase II, Placebo-controlled

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Cell-Derived Trivalent Subunit Influenza Vaccine
Intervention Description
surface antigen, inactivated, prepared in cell cultures
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.
Time Frame
3 weeks
Title
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
Time Frame
6 months
Title
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.
Time Frame
3 weeks
Title
To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria Known to be allergic to constituents of the vaccine. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator. Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanka de Voogd, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 45690
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Site Reference ID/Investigator# 45687
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Site Reference ID/Investigator# 45697
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Site Reference ID/Investigator# 45691
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Site Reference ID/Investigator# 45689
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Site Reference ID/Investigator# 45694
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Site Reference ID/Investigator# 45682
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Site Reference ID/Investigator# 45684
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Site Reference ID/Investigator# 45685
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Site Reference ID/Investigator# 45686
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Site Reference ID/Investigator# 45688
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site Reference ID/Investigator# 45696
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Site Reference ID/Investigator# 45683
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Site Reference ID/Investigator# 45695
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Site Reference ID/Investigator# 45692
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination

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