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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier:
NCT00889889
First received: April 28, 2009
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889889

Locations
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
Investigators
Study Director: Hanka de Voogd, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier: NCT00889889     History of Changes
Other Study ID Numbers: S203.2.004
Study First Received: April 28, 2009
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Influenza
Phase II
Placebo-controlled

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014