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Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination

NCT ID: NCT00889889

Last Updated: 2013-10-25

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

1270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-01-31

Brief Summary

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Immunogenicity and safety of a cell-derived influenza vaccine in adults aged \>= 18 and \<= 64 years, plus revaccination

Detailed Description

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Conditions

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Influenza

Keywords

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Influenza Phase II Placebo-controlled

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

Group Type EXPERIMENTAL

Cell-Derived Trivalent Subunit Influenza Vaccine

Intervention Type BIOLOGICAL

surface antigen, inactivated, prepared in cell cultures

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo

Interventions

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Cell-Derived Trivalent Subunit Influenza Vaccine

surface antigen, inactivated, prepared in cell cultures

Intervention Type BIOLOGICAL

Placebo

Placebo

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 aged \>= 18 and \<= 64 years.
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

18 Years

Maximum Eligible Age

64 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

Locations

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Site Reference ID/Investigator# 45690

Jacksonville, Florida, United States

Site Status

Site Reference ID/Investigator# 45687

Pembroke Pines, Florida, United States

Site Status

Site Reference ID/Investigator# 45697

South Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 45691

Lenexa, Kansas, United States

Site Status

Site Reference ID/Investigator# 45689

Overland Park, Kansas, United States

Site Status

Site Reference ID/Investigator# 45694

Wichita, Kansas, United States

Site Status

Site Reference ID/Investigator# 45682

Lexington, Kentucky, United States

Site Status

Site Reference ID/Investigator# 45684

Kansas City, Missouri, United States

Site Status

Site Reference ID/Investigator# 45685

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 45686

Las Vegas, Nevada, United States

Site Status

Site Reference ID/Investigator# 45688

Raleigh, North Carolina, United States

Site Status

Site Reference ID/Investigator# 45696

Nashville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 45683

Austin, Texas, United States

Site Status

Site Reference ID/Investigator# 45695

Fort Worth, Texas, United States

Site Status

Site Reference ID/Investigator# 45692

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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S203.2.004

Identifier Type: -

Identifier Source: org_study_id