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Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly

Primary Purpose

Influenza Vaccines

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
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 Vaccines focused on measuring influenza, active-controlled, Phase 2

Eligibility Criteria

61 Years - undefined (Adult, Older 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 (elderly)
  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# 45005
  • Site Reference ID/Investigator# 45004
  • Site Reference ID/Investigator# 45007
  • Site Reference ID/Investigator# 45012
  • Site Reference ID/Investigator# 45009
  • Site Reference ID/Investigator# 45010
  • Site Reference ID/Investigator# 45013
  • Site Reference ID/Investigator# 45017
  • Site Reference ID/Investigator# 45015
  • Site Reference ID/Investigator# 45016
  • Site Reference ID/Investigator# 45018
  • Site Reference ID/Investigator# 45019

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose

15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose

Outcomes

Primary Outcome Measures

To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.
To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.
To assess the safety and tolerability of the cell-derived vaccine following revaccination.

Secondary Outcome Measures

To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.

Full Information

First Posted
November 13, 2009
Last Updated
October 26, 2011
Sponsor
Abbott Biologicals
Collaborators
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01013675
Brief Title
Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly
Official Title
Randomized, Double-blind, Active -Controlled Trial to Assess Safety and Immunogenicity of Solvay's Cell-derived Influenza Vaccine, Including Revaccination, in Elderly Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 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
A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.
Detailed Description
This current phase II study is to pursue objectives similar to those of the ongoing adult phase II trial, but to expand into the elderly population who are more than 60 years of age. The results of this randomized, double blind, egg derived influenza vaccine (Influvac) - controlled, parallel-trial, in healthy elderly subjects are to be conducted over two consecutive years in multiple centers in Europe. At study initiation 600 subjects will be randomly allocated to receive the cell-derived or egg-derived influenza vaccine. At start of the second year subjects will be randomly re-allocated following stratification based upon the initial drug they were allocated and had received.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Vaccines
Keywords
influenza, active-controlled, Phase 2

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose
Arm Title
2
Arm Type
Active Comparator
Arm Description
15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose
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 ®)
Primary Outcome Measure Information:
Title
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.
Time Frame
3 weeks
Title
To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.
Time Frame
6 months
Title
To assess the safety and tolerability of the cell-derived vaccine following revaccination.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.
Time Frame
3 weeks
Title
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
61 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 (elderly) 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 Healthcare Products B.V
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 45005
City
Benatky nad Jizerou
ZIP/Postal Code
294 71
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 45004
City
Hradec Kralove
ZIP/Postal Code
500 03
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 45007
City
Paide
ZIP/Postal Code
72713
Country
Estonia
Facility Name
Site Reference ID/Investigator# 45012
City
Saku
ZIP/Postal Code
75501
Country
Estonia
Facility Name
Site Reference ID/Investigator# 45009
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Site Reference ID/Investigator# 45010
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Site Reference ID/Investigator# 45013
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Site Reference ID/Investigator# 45017
City
Kaunas
ZIP/Postal Code
47144
Country
Lithuania
Facility Name
Site Reference ID/Investigator# 45015
City
Kaunas
ZIP/Postal Code
48259
Country
Lithuania
Facility Name
Site Reference ID/Investigator# 45016
City
Kaunas
ZIP/Postal Code
49456
Country
Lithuania
Facility Name
Site Reference ID/Investigator# 45018
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Site Reference ID/Investigator# 45019
City
Klaipeda
ZIP/Postal Code
92231
Country
Lithuania

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly

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