Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Immune Responses Induced by Different Licensed Influenza Vaccines

This study has been completed.
Information provided by (Responsible Party):
Mary Co, University of Massachusetts, Worcester Identifier:
First received: May 13, 2009
Last updated: April 29, 2016
Last verified: April 2016
The goal of this research is to find out how the body's immune system responds to different manufacturer's "flu" vaccines.

Condition Intervention
Immune Response
Biological: Fluvirin
Biological: Flulaval
Biological: Fluzone
Biological: Fluarix
Biological: Afluria

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Immune Response Induced by Different Manufacturers of Influenza Vaccines

Resource links provided by NLM:

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • T cell responses following immunization [ Time Frame: Prevaccination and approximately 7,14,1month and 3-5 months post vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • antibody responses following immunization [ Time Frame: Prevaccination and approximately Day 7,14,30 and 3-5 months post vaccination ] [ Designated as safety issue: No ]

Enrollment: 193
Study Start Date: October 2008
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Biological: Flulaval
one 0.5-mL dose via intramuscular injection
Active Comparator: 2 Biological: Fluvirin
one 0.5-mL dose via intramuscular injection
Active Comparator: 3 Biological: Fluzone
one 0.5-mL dose via intramuscular injection
Active Comparator: 4 Biological: Fluarix
one 0.5-mL dose via intramuscular injection
Active Comparator: 5 Biological: Afluria
one 0.5-mL dose via intramuscular injection

Detailed Description:
There are currently five licensed inactivated influenza vaccines approved for use in the United States by the Food and Drug Administration.Current influenza virus vaccines consist of 3 components: the HA protein from an H1N1 virus, an H3N2 and an influenza B virus.Influenza vaccines are evaluated and approved by the FDA on the basis of HA and NA content. However, different manufacturing processes are involved in the preparation of these commercial vaccines and evidence suggests that each of these vaccines contain similar patterns of HA protein but different patterns of influenza influenza internal proteins such as NP and M1. The presence of these additional internal proteins of influenza virus which are targets of T cell responses suggest not only the potential for additional protection derived from influenza vaccines other than antibody mediated protection but also differential levels of T cell mediated protection between different manufacturers of commercial influenza vaccines.Each subject will have four blood samples taken- prevaccination and at Days 7, 14,30 and 3-5 months post vaccination. These samples will be tested for T and B cell responses and the results compared between different manufacturers.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adults (18-50 years of age)
  • Willing to donate a blood sample multiple times
  • Willing to sign informed consent and HIPAA

Exclusion Criteria:

  • Known systemic hypersensitivity reactions to egg proteins (eggs or egg products), to chicken proteins
  • Known hypersensitivity to neomycin, thimerosol (mercury derivative), neomycin, or polymyxin
  • Previous life threatening reaction to influenza vaccine
  • Individuals with altered immunocompetence state from medical condition ( HIV, cancer) or through immunosuppressive therapy(irradiation,corticosteroids, antimetabolites, alkylating agents, cytotoxic agents)
  • Occurrence of neurological syndrome within six weeks of previous influenza immunization
  • Active neurological disorder characterized by changing neurological disorder
  • Pregnancy
  • Acute febrile illness
  • History of anemia or bleeding disorders
  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: NCT00902278

United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
Principal Investigator: Mary Dawn T Co, MD University of Massachusetts, Worcester
  More Information

Responsible Party: Mary Co, Study Principle Investigator, University of Massachusetts, Worcester Identifier: NCT00902278     History of Changes
Other Study ID Numbers: H 13000  5U19AI057319-05S1 
Study First Received: May 13, 2009
Last Updated: April 29, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
influenzavirus A
influenzavirus B
human influenza
T lymphocytes
influenza vaccines

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 October 26, 2016