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Completed

NCT Number: NCT01013675

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

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

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Key information

Conditions

Influenza Vaccines Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

61 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 45005, Benátky nad Jizerou, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

influenza vaccine

Biological

surface antigen, inactivated, prepared in cell cultures

Primary outcomes

  1. 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

  2. To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.

    Time frame: 6 months

  3. To assess the safety and tolerability of the cell-derived vaccine following revaccination.

    Time frame: 6 months

Secondary outcomes

  1. 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

  2. To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Abbott Biologicals

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2009
Registry last updated
Oct 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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