Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine

NCT ID: NCT00999206

Last Updated: 2011-08-26

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

PHASE3

Total Enrollment

3138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-08-31

Brief Summary

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A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity

Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Influenza Vaccine

Intervention Type BIOLOGICAL

surface antigen, inactivated, prepared in cell cultures

2

Group Type EXPERIMENTAL

Influenza Vaccine

Intervention Type BIOLOGICAL

surface antigen, inactivated, prepared in cell cultures

3

Group Type EXPERIMENTAL

Influenza Vaccine

Intervention Type BIOLOGICAL

surface antigen, inactivated, prepared in cell cultures

4

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

Influenza Vaccine

surface antigen, inactivated, prepared in cell cultures

Intervention Type BIOLOGICAL

Influenza Vaccine

surface antigen, inactivated, prepared in cell cultures

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Female or male subjects \>= 18 years of age (adults \>= 18 to \< =60 years of age or elderly \>= 61 years of age).
2. Willing and able to give informed consent before any protocol procedures are performed.
3. Able to adhere to visit schedules and all protocol required study procedures.
4. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).

Exclusion Criteria

1. Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
3. A serious adverse reaction after a previous (influenza) vaccination.
4. A history of Guillain-Barré syndrome.
5. Known to be allergic to constituents of the study vaccines.
Minimum Eligible Age

18 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# 44652

Adelaide, , Australia

Site Status

Site Reference ID/Investigator# 44662

Auchenflower, , Australia

Site Status

Site Reference ID/Investigator# 44651

Blacktown, , Australia

Site Status

Site Reference ID/Investigator# 44659

Blacktown, , Australia

Site Status

Site Reference ID/Investigator# 44647

Broadmeadow, , Australia

Site Status

Site Reference ID/Investigator# 44649

Caboolture, , Australia

Site Status

Site Reference ID/Investigator# 44646

Carina Heights, , Australia

Site Status

Site Reference ID/Investigator# 44650

Herston, , Australia

Site Status

Site Reference ID/Investigator# 44663

Hornsby, , Australia

Site Status

Site Reference ID/Investigator# 44645

Kippa-Ring, , Australia

Site Status

Site Reference ID/Investigator# 44644

Malvern East, , Australia

Site Status

Site Reference ID/Investigator# 44648

Maroubra Junction, , Australia

Site Status

Site Reference ID/Investigator# 44643

Sherwood, , Australia

Site Status

Site Reference ID/Investigator# 44653

Christchurch, , New Zealand

Site Status

Site Reference ID/Investigator# 44658

Dunedin, , New Zealand

Site Status

Site Reference ID/Investigator# 44656

Grafton, , New Zealand

Site Status

Site Reference ID/Investigator# 44655

Rotorua, , New Zealand

Site Status

Site Reference ID/Investigator# 44654

Tauranga, , New Zealand

Site Status

Site Reference ID/Investigator# 44657

Wellington, , New Zealand

Site Status

Countries

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Australia New Zealand

Other Identifiers

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S203.3.013

Identifier Type: -

Identifier Source: org_study_id

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