Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier:
NCT01013675
First received: November 13, 2009
Last updated: October 26, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Influenza Vaccines
 Biological: Influenza Vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To assess the safety and tolerability of the cell-derived vaccine following revaccination. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 622
Study Start Date: November 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose
 Biological: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Active Comparator: 2
15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose
 Biological: Influenza Vaccine
surface antigen, inactivated, prepared in egg (influvac ®)

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.

  Eligibility

Ages Eligible for Study:   61 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013675

Locations
Czech Republic
Site Reference ID/Investigator# 45005
Benatky nad Jizerou, Czech Republic, 294 71
Site Reference ID/Investigator# 45004
Hradec Kralove, Czech Republic, 500 03
Estonia
Site Reference ID/Investigator# 45007
Paide, Estonia, 72713
Site Reference ID/Investigator# 45012
Saku, Estonia, 75501
Site Reference ID/Investigator# 45010
Tallinn, Estonia, 10617
Site Reference ID/Investigator# 45009
Tallinn, Estonia, 10617
Site Reference ID/Investigator# 45013
Tartu, Estonia, 51014
Lithuania
Site Reference ID/Investigator# 45015
Kaunas, Lithuania, 48259
Site Reference ID/Investigator# 45016
Kaunas, Lithuania, 49456
Site Reference ID/Investigator# 45017
Kaunas, Lithuania, 47144
Site Reference ID/Investigator# 45018
Kaunas, Lithuania, 50009
Site Reference ID/Investigator# 45019
Klaipeda, Lithuania, 92231
Sponsors and Collaborators
Abbott Biologicals
Quintiles
Investigators
Study Director: Hanka de Voogd, MD Abbott Healthcare Products B.V
  More Information

No publications provided

Responsible Party: Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier: NCT01013675     History of Changes
Other Study ID Numbers: S203.2.009, 2009-014767-40
Study First Received: November 13, 2009
Last Updated: October 26, 2011
Health Authority: Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Abbott:
influenza
active-controlled
Phase 2

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013