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

September 27, 2013 updated by: Abbott Biologicals

Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Cell-Derived Trivalent Subunit Influenza Vaccine in Subjects Aged >= 18 Years and <= 64 Years During Two Consecutive Years.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1270

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Site Reference ID/Investigator# 45690
      • Pembroke Pines, Florida, United States, 33024
        • Site Reference ID/Investigator# 45687
      • South Miami, Florida, United States, 33143
        • Site Reference ID/Investigator# 45697
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Site Reference ID/Investigator# 45691
      • Overland Park, Kansas, United States, 66212
        • Site Reference ID/Investigator# 45689
      • Wichita, Kansas, United States, 67207
        • Site Reference ID/Investigator# 45694
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Site Reference ID/Investigator# 45682
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Site Reference ID/Investigator# 45684
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Site Reference ID/Investigator# 45685
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Site Reference ID/Investigator# 45686
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Site Reference ID/Investigator# 45688
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Site Reference ID/Investigator# 45696
    • Texas
      • Austin, Texas, United States, 78705
        • Site Reference ID/Investigator# 45683
      • Fort Worth, Texas, United States, 76135
        • Site Reference ID/Investigator# 45695
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Site Reference ID/Investigator# 45692

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: Cell-Derived Trivalent Subunit Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Placebo Comparator: 2
Biological: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.
Time Frame: 3 weeks
3 weeks
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
Time Frame: 6 months
6 months
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.
Time Frame: 3 weeks
3 weeks
To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Biologicals

Collaborators

Quintiles, Inc.

Investigators

  • Study Director: Hanka de Voogd, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (Estimate)

April 29, 2009

Study Record Updates

Last Update Posted (Estimate)

October 25, 2013

Last Update Submitted That Met QC Criteria

September 27, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S203.2.004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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