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

Sponsor
Abbott Biologicals (Industry)
Overall Status
Completed
CT.gov ID
NCT00889889
Collaborator
Quintiles, Inc. (Industry)
1,270
Enrollment
15
Locations
2
Arms
20
Duration (Months)
84.7
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Cell-Derived Trivalent Subunit Influenza Vaccine
  • Biological: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
1270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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.
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines. [3 weeks]

  2. To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo. [6 months]

Secondary Outcome Measures

  1. To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine. [6 months]

  2. To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination. [3 weeks]

  3. To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine. [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site Reference ID/Investigator# 45690 Jacksonville Florida United States 32216
2 Site Reference ID/Investigator# 45687 Pembroke Pines Florida United States 33024
3 Site Reference ID/Investigator# 45697 South Miami Florida United States 33143
4 Site Reference ID/Investigator# 45691 Lenexa Kansas United States 66219
5 Site Reference ID/Investigator# 45689 Overland Park Kansas United States 66212
6 Site Reference ID/Investigator# 45694 Wichita Kansas United States 67207
7 Site Reference ID/Investigator# 45682 Lexington Kentucky United States 40509
8 Site Reference ID/Investigator# 45684 Kansas City Missouri United States 64114
9 Site Reference ID/Investigator# 45685 Omaha Nebraska United States 68134
10 Site Reference ID/Investigator# 45686 Las Vegas Nevada United States 89104
11 Site Reference ID/Investigator# 45688 Raleigh North Carolina United States 27612
12 Site Reference ID/Investigator# 45696 Nashville Tennessee United States 37203
13 Site Reference ID/Investigator# 45683 Austin Texas United States 78705
14 Site Reference ID/Investigator# 45695 Fort Worth Texas United States 76135
15 Site Reference ID/Investigator# 45692 Salt Lake City Utah United States 84124

Sponsors and Collaborators

  • Abbott Biologicals
  • Quintiles, Inc.

Investigators

  • Study Director: Hanka de Voogd, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Biologicals
ClinicalTrials.gov Identifier:
NCT00889889
Other Study ID Numbers:
  • S203.2.004
First Posted:
Apr 29, 2009
Last Update Posted:
Oct 25, 2013
Last Verified:
Sep 1, 2013
Keywords provided by Abbott Biologicals
Influenza
Phase II
Placebo-controlled
Additional relevant MeSH terms:
Influenza, Human

Study Results

No Results Posted as of Oct 25, 2013