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

August 25, 2011 updated by: Abbott Biologicals

Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3138

Phase

  • Phase 3

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

  • Australia
      • Adelaide, Australia, 5000
        • Site Reference ID/Investigator# 44652
      • Auchenflower, Australia, 4066
        • Site Reference ID/Investigator# 44662
      • Blacktown, Australia, 2148
        • Site Reference ID/Investigator# 44651
      • Blacktown, Australia, 2148
        • Site Reference ID/Investigator# 44659
      • Broadmeadow, Australia, 2292
        • Site Reference ID/Investigator# 44647
      • Caboolture, Australia, 4510
        • Site Reference ID/Investigator# 44649
      • Carina Heights, Australia, 4152
        • Site Reference ID/Investigator# 44646
      • Herston, Australia, 4006
        • Site Reference ID/Investigator# 44650
      • Hornsby, Australia, 2077
        • Site Reference ID/Investigator# 44663
      • Kippa-Ring, Australia, 4020
        • Site Reference ID/Investigator# 44645
      • Malvern East, Australia, 3145
        • Site Reference ID/Investigator# 44644
      • Maroubra Junction, Australia, 2035
        • Site Reference ID/Investigator# 44648
      • Sherwood, Australia, 4075
        • Site Reference ID/Investigator# 44643
  • New Zealand
      • Christchurch, New Zealand
        • Site Reference ID/Investigator# 44653
      • Dunedin, New Zealand, 9012
        • Site Reference ID/Investigator# 44658
      • Grafton, New Zealand, 1150
        • Site Reference ID/Investigator# 44656
      • Rotorua, New Zealand, 3010
        • Site Reference ID/Investigator# 44655
      • Tauranga, New Zealand, 3110
        • Site Reference ID/Investigator# 44654
      • Wellington, New Zealand, 6035
        • Site Reference ID/Investigator# 44657

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Biological: Influenza Vaccine
surface antigen, inactivated, prepared in egg (influvac ®)
Experimental: 2
Biological: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Biological: Influenza Vaccine
surface antigen, inactivated, prepared in egg (influvac ®)
Experimental: 3
Biological: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Biological: Influenza Vaccine
surface antigen, inactivated, prepared in egg (influvac ®)
Active Comparator: 4
Biological: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Biological: Influenza Vaccine
surface antigen, inactivated, prepared in egg (influvac ®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase
Time Frame: 3 weeks
3 weeks

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 Healthcare Products B.V.

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

January 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (Estimate)

October 21, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2011

Last Update Submitted That Met QC Criteria

August 25, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S203.3.013

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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