Clinical trial NCT01013675: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza Vaccines
Keywords: influenza
active-controlled
Phase 2
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-11-16
Enrollment: 622
Sex: ALL
Minimum age (years): 61
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.
timeFrame: 3 weeks
measure: To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.
timeFrame: 6 months
measure: To assess the safety and tolerability of the cell-derived vaccine following revaccination.
timeFrame: 6 months
Secondary outcomes:
measure: To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.
timeFrame: 3 weeks
measure: To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
timeFrame: 6 months
Other outcomes:
Locations:
city: Benatky nad Jizerou
country: Czech Republic
facility: Site Reference ID/Investigator# 45005
city: Hradec Kralove
country: Czech Republic
facility: Site Reference ID/Investigator# 45004
city: Paide
country: Estonia
facility: Site Reference ID/Investigator# 45007
city: Saku
country: Estonia
facility: Site Reference ID/Investigator# 45012
city: Tallinn
country: Estonia
facility: Site Reference ID/Investigator# 45009
city: Tallinn
country: Estonia
facility: Site Reference ID/Investigator# 45010
city: Tartu
country: Estonia
facility: Site Reference ID/Investigator# 45013
city: Kaunas
country: Lithuania
facility: Site Reference ID/Investigator# 45017
city: Kaunas
country: Lithuania
facility: Site Reference ID/Investigator# 45015
city: Kaunas
country: Lithuania
facility: Site Reference ID/Investigator# 45016
city: Kaunas
country: Lithuania
facility: Site Reference ID/Investigator# 45018
city: Klaipeda
country: Lithuania
facility: Site Reference ID/Investigator# 45019
Study officials:
affiliation: Abbott Healthcare Products B.V
name: Hanka de Voogd, MD
role: STUDY_DIRECTOR
References: