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

Randomized, Double-blind, Active -Controlled Trial to Assess Safety and Immunogenicity of Solvay's Cell-derived Influenza Vaccine, Including Revaccination, in Elderly Subjects

A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.

Study Overview

• Status: Completed
• Conditions: Influenza Vaccines
• Intervention / Treatment: Biological: Influenza Vaccine; Biological: Influenza Vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 622
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czech Republic
  • Benatky nad Jizerou, Czech Republic, 294 71
    • Site Reference ID/Investigator# 45005
  • Hradec Kralove, Czech Republic, 500 03
    • Site Reference ID/Investigator# 45004
• Estonia
  • Paide, Estonia, 72713
    • Site Reference ID/Investigator# 45007
  • Saku, Estonia, 75501
    • Site Reference ID/Investigator# 45012
  • Tallinn, Estonia, 10617
    • Site Reference ID/Investigator# 45009
  • Tallinn, Estonia, 10617
    • Site Reference ID/Investigator# 45010
  • Tartu, Estonia, 51014
    • Site Reference ID/Investigator# 45013
• Lithuania
  • Kaunas, Lithuania, 47144
    • Site Reference ID/Investigator# 45017
  • Kaunas, Lithuania, 48259
    • Site Reference ID/Investigator# 45015
  • Kaunas, Lithuania, 49456
    • Site Reference ID/Investigator# 45016
  • Kaunas, Lithuania, 50009
    • Site Reference ID/Investigator# 45018
  • Klaipeda, Lithuania, 92231
    • Site Reference ID/Investigator# 45019

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose	Biological: Influenza Vaccine; surface antigen, inactivated, prepared in cell cultures; Biological: Influenza Vaccine; surface antigen, inactivated, prepared in egg (influvac ®)
Active Comparator: 2; 15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose	Biological: Influenza Vaccine; surface antigen, inactivated, prepared in cell cultures; Biological: Influenza Vaccine; surface antigen, inactivated, prepared in egg (influvac ®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.	3 weeks
To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.	6 months
To assess the safety and tolerability of the cell-derived vaccine following revaccination.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.	3 weeks
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.	6 months

Collaborators and Investigators

• Sponsor: Abbott Biologicals
• Collaborators: Quintiles, Inc.
• Investigators: Study Director: Hanka de Voogd, MD, Abbott Healthcare Products B.V

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: November 13, 2009
• First Submitted That Met QC Criteria: November 13, 2009
• First Posted (Estimate): November 16, 2009

Study Record Updates

• Last Update Posted (Estimate): October 27, 2011
• Last Update Submitted That Met QC Criteria: October 26, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: influenza; Phase 2; active-controlled
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: S203.2.009; 2009-014767-40 (EudraCT Number)