Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine
NCT ID: NCT00999206
Last Updated: 2011-08-26
Study Results
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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COMPLETED
PHASE3
3138 participants
INTERVENTIONAL
2010-01-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
2
Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
3
Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
4
Influenza Vaccine
surface antigen, inactivated, prepared in egg (influvac ®)
Interventions
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Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Influenza Vaccine
surface antigen, inactivated, prepared in egg (influvac ®)
Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Quintiles, Inc.
INDUSTRY
Abbott Biologicals
INDUSTRY
Responsible Party
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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 Reference ID/Investigator# 44662
Auchenflower, , Australia
Site Reference ID/Investigator# 44651
Blacktown, , Australia
Site Reference ID/Investigator# 44659
Blacktown, , Australia
Site Reference ID/Investigator# 44647
Broadmeadow, , Australia
Site Reference ID/Investigator# 44649
Caboolture, , Australia
Site Reference ID/Investigator# 44646
Carina Heights, , Australia
Site Reference ID/Investigator# 44650
Herston, , Australia
Site Reference ID/Investigator# 44663
Hornsby, , Australia
Site Reference ID/Investigator# 44645
Kippa-Ring, , Australia
Site Reference ID/Investigator# 44644
Malvern East, , Australia
Site Reference ID/Investigator# 44648
Maroubra Junction, , Australia
Site Reference ID/Investigator# 44643
Sherwood, , Australia
Site Reference ID/Investigator# 44653
Christchurch, , New Zealand
Site Reference ID/Investigator# 44658
Dunedin, , New Zealand
Site Reference ID/Investigator# 44656
Grafton, , New Zealand
Site Reference ID/Investigator# 44655
Rotorua, , New Zealand
Site Reference ID/Investigator# 44654
Tauranga, , New Zealand
Site Reference ID/Investigator# 44657
Wellington, , New Zealand
Countries
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Other Identifiers
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S203.3.013
Identifier Type: -
Identifier Source: org_study_id
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