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

This study has been completed.
Quintiles, Inc.
Information provided by (Responsible Party):
Abbott ( Abbott Biologicals ) Identifier:
First received: April 28, 2009
Last updated: September 27, 2013
Last verified: September 2013
Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination

Condition Intervention Phase
Biological: Cell-Derived Trivalent Subunit Influenza Vaccine
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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.

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]
  • To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo. [ Time Frame: 6 months ]

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

Enrollment: 1270
Study Start Date: May 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Cell-Derived Trivalent Subunit Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
Placebo Comparator: 2 Biological: Placebo


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00889889

United States, Florida
Site Reference ID/Investigator# 45690
Jacksonville, Florida, United States, 32216
Site Reference ID/Investigator# 45687
Pembroke Pines, Florida, United States, 33024
Site Reference ID/Investigator# 45697
South Miami, Florida, United States, 33143
United States, Kansas
Site Reference ID/Investigator# 45691
Lenexa, Kansas, United States, 66219
Site Reference ID/Investigator# 45689
Overland Park, Kansas, United States, 66212
Site Reference ID/Investigator# 45694
Wichita, Kansas, United States, 67207
United States, Kentucky
Site Reference ID/Investigator# 45682
Lexington, Kentucky, United States, 40509
United States, Missouri
Site Reference ID/Investigator# 45684
Kansas City, Missouri, United States, 64114
United States, Nebraska
Site Reference ID/Investigator# 45685
Omaha, Nebraska, United States, 68134
United States, Nevada
Site Reference ID/Investigator# 45686
Las Vegas, Nevada, United States, 89104
United States, North Carolina
Site Reference ID/Investigator# 45688
Raleigh, North Carolina, United States, 27612
United States, Tennessee
Site Reference ID/Investigator# 45696
Nashville, Tennessee, United States, 37203
United States, Texas
Site Reference ID/Investigator# 45683
Austin, Texas, United States, 78705
Site Reference ID/Investigator# 45695
Fort Worth, Texas, United States, 76135
United States, Utah
Site Reference ID/Investigator# 45692
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Abbott Biologicals
Quintiles, Inc.
Study Director: Hanka de Voogd, MD Abbott
  More Information

Responsible Party: Abbott Biologicals Identifier: NCT00889889     History of Changes
Other Study ID Numbers: S203.2.004
Study First Received: April 28, 2009
Last Updated: September 27, 2013

Keywords provided by Abbott:
Phase II

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on April 26, 2017