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A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00743275
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : February 23, 2010
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:

To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation.

To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.


Condition or disease Intervention/treatment Phase
Influenza Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)
Study Start Date : August 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study Group
Participants received one dose of Fluzone® vaccine on Day 0.
 Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)
0.5 mL, intramuscular
Other Name: Fluzone®


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine. [ Time Frame: Days 0-3 post-vaccination ]
    Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering

  2. Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation [ Time Frame: Day 0 and 21 days post-vaccination ]
  3. Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection) [ Time Frame: 21 days post-vaccination ]
    Seroprotection was defined as post-vaccination titer value of ≥ 1:40.

  4. Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion) [ Time Frame: 21 days post-vaccination ]
    Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is 18 years of age or older on the day of inclusion.
  • Participant willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
  • Participant in reasonably good health as assessed by the Investigator.
  • Participant willing and able to give informed consent.
  • For a woman, inability to bear a child or negative serum/urine pregnancy test.

Exclusion Criteria:

  • Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
  • An acute illness with or without fever in the 72 hours preceding enrollment in the trial.
  • Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) or review of systems.
  • Self-reported history of severe adverse event to any influenza vaccine.
  • Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
  • Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 2.
  • Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.*
  • Immunocompromising condition or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months.
  • Receipt of blood or blood products within the 3 months preceding enrollment in the study.
  • Diabetes mellitus requiring pharmacological control.
  • Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
  • Person deprived of freedom by an administrative or court order (having legal or medical guardian).
  • For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
  • Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Prior personal history of Guillain-Barré syndrome. * Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743275


Locations
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United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
More Information
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Additional Information:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00743275    
Other Study ID Numbers: GRC41
First Posted: August 28, 2008    Key Record Dates
Results First Posted: February 23, 2010
Last Update Posted: May 16, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Influenza
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases