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Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Influenza Vaccine
Influenza Vaccine
Influenza Vaccine
Influenza Vaccine
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, Vaccine, CHMP criteria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  1. Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age).
  2. Willing and able to give informed consent before any protocol procedures are performed.
  3. Able to adhere to visit schedules and all protocol required study procedures.
  4. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).

Exclusion Criteria

  1. Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
  2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
  3. A serious adverse reaction after a previous (influenza) vaccination.
  4. A history of Guillain-Barré syndrome.
  5. Known to be allergic to constituents of the study vaccines.

Sites / Locations

  • Site Reference ID/Investigator# 44652
  • Site Reference ID/Investigator# 44662
  • Site Reference ID/Investigator# 44651
  • Site Reference ID/Investigator# 44659
  • Site Reference ID/Investigator# 44647
  • Site Reference ID/Investigator# 44649
  • Site Reference ID/Investigator# 44646
  • Site Reference ID/Investigator# 44650
  • Site Reference ID/Investigator# 44663
  • Site Reference ID/Investigator# 44645
  • Site Reference ID/Investigator# 44644
  • Site Reference ID/Investigator# 44648
  • Site Reference ID/Investigator# 44643
  • Site Reference ID/Investigator# 44653
  • Site Reference ID/Investigator# 44658
  • Site Reference ID/Investigator# 44656
  • Site Reference ID/Investigator# 44655
  • Site Reference ID/Investigator# 44654
  • Site Reference ID/Investigator# 44657

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase

Secondary Outcome Measures

Full Information

First Posted
October 20, 2009
Last Updated
August 25, 2011
Sponsor
Abbott Biologicals
Collaborators
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00999206
Brief Title
Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine
Official Title
Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (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
A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Vaccine, CHMP criteria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccine
Intervention Description
surface antigen, inactivated, prepared in cell cultures
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccine
Intervention Description
surface antigen, inactivated, prepared in egg (influvac ®)
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccine
Intervention Description
surface antigen, inactivated, prepared in cell cultures
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccine
Intervention Description
surface antigen, inactivated, prepared in cell cultures
Primary Outcome Measure Information:
Title
Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age). Willing and able to give informed consent before any protocol procedures are performed. Able to adhere to visit schedules and all protocol required study procedures. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination). Exclusion Criteria Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22). Presence of any significant condition that may prohibit inclusion as determined by the Investigator. A serious adverse reaction after a previous (influenza) vaccination. A history of Guillain-Barré syndrome. Known to be allergic to constituents of the study vaccines.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanka de Voogd, MD
Organizational Affiliation
Abbott Healthcare Products B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 44652
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Site Reference ID/Investigator# 44662
City
Auchenflower
ZIP/Postal Code
4066
Country
Australia
Facility Name
Site Reference ID/Investigator# 44651
City
Blacktown
ZIP/Postal Code
2148
Country
Australia
Facility Name
Site Reference ID/Investigator# 44659
City
Blacktown
ZIP/Postal Code
2148
Country
Australia
Facility Name
Site Reference ID/Investigator# 44647
City
Broadmeadow
ZIP/Postal Code
2292
Country
Australia
Facility Name
Site Reference ID/Investigator# 44649
City
Caboolture
ZIP/Postal Code
4510
Country
Australia
Facility Name
Site Reference ID/Investigator# 44646
City
Carina Heights
ZIP/Postal Code
4152
Country
Australia
Facility Name
Site Reference ID/Investigator# 44650
City
Herston
ZIP/Postal Code
4006
Country
Australia
Facility Name
Site Reference ID/Investigator# 44663
City
Hornsby
ZIP/Postal Code
2077
Country
Australia
Facility Name
Site Reference ID/Investigator# 44645
City
Kippa-Ring
ZIP/Postal Code
4020
Country
Australia
Facility Name
Site Reference ID/Investigator# 44644
City
Malvern East
ZIP/Postal Code
3145
Country
Australia
Facility Name
Site Reference ID/Investigator# 44648
City
Maroubra Junction
ZIP/Postal Code
2035
Country
Australia
Facility Name
Site Reference ID/Investigator# 44643
City
Sherwood
ZIP/Postal Code
4075
Country
Australia
Facility Name
Site Reference ID/Investigator# 44653
City
Christchurch
Country
New Zealand
Facility Name
Site Reference ID/Investigator# 44658
City
Dunedin
ZIP/Postal Code
9012
Country
New Zealand
Facility Name
Site Reference ID/Investigator# 44656
City
Grafton
ZIP/Postal Code
1150
Country
New Zealand
Facility Name
Site Reference ID/Investigator# 44655
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
Site Reference ID/Investigator# 44654
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
Site Reference ID/Investigator# 44657
City
Wellington
ZIP/Postal Code
6035
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine

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