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

NCT ID: NCT01013675

Last Updated: 2011-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

622 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Influenza Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

Influenza Vaccine

Intervention Type BIOLOGICAL

surface antigen, inactivated, prepared in cell cultures

2

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

Group Type ACTIVE_COMPARATOR

Influenza Vaccine

Intervention Type BIOLOGICAL

surface antigen, inactivated, prepared in egg (influvac ®)

Interventions

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Influenza Vaccine

surface antigen, inactivated, prepared in cell cultures

Intervention Type BIOLOGICAL

Influenza Vaccine

surface antigen, inactivated, prepared in egg (influvac ®)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

Abbott Biologicals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hanka de Voogd, MD

Role: STUDY_DIRECTOR

Abbott Healthcare Products B.V

Locations

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Site Reference ID/Investigator# 45005

Benátky nad Jizerou, , Czechia

Site Status

Site Reference ID/Investigator# 45004

Hradec Králové, , Czechia

Site Status

Site Reference ID/Investigator# 45007

Paide, , Estonia

Site Status

Site Reference ID/Investigator# 45012

Saku, , Estonia

Site Status

Site Reference ID/Investigator# 45009

Tallinn, , Estonia

Site Status

Site Reference ID/Investigator# 45010

Tallinn, , Estonia

Site Status

Site Reference ID/Investigator# 45013

Tartu, , Estonia

Site Status

Site Reference ID/Investigator# 45017

Kaunas, , Lithuania

Site Status

Site Reference ID/Investigator# 45015

Kaunas, , Lithuania

Site Status

Site Reference ID/Investigator# 45016

Kaunas, , Lithuania

Site Status

Site Reference ID/Investigator# 45018

Kaunas, , Lithuania

Site Status

Site Reference ID/Investigator# 45019

Klaipėda, , Lithuania

Site Status

Countries

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Czechia Estonia Lithuania

Other Identifiers

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2009-014767-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S203.2.009

Identifier Type: -

Identifier Source: org_study_id