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Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00623181
First received: February 6, 2008
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.

To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination


Condition Intervention Phase
Influenza
Biological: Fluzone: Influenza virus vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination [ Time Frame: Day 0 and up to 7 days post-vaccination ] [ Designated as safety issue: No ]

    Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2.

    Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.


  • Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination [ Time Frame: Days 0, 3, and 7 after vaccination ] [ Designated as safety issue: No ]

    Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10.

    Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.



Other Outcome Measures:
  • Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection [ Time Frame: Days 0 through 7 post-vaccination ] [ Designated as safety issue: No ]

    Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, Ecchymosis.

    Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.


  • Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection [ Time Frame: Days 0 through 7 post-vaccination ] [ Designated as safety issue: No ]

    Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia.

    Data for this outcome were based on the first vaccination type, intradermal or intramuscular.



Enrollment: 110
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluzone Intradermal First, Then Fluzone Intramuscular Biological: Fluzone: Influenza virus vaccine
0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid
Other Name: Fluzone®
Experimental: Fluzone Intramuscular First, Then Fluzone Intradermal Biological: Fluzone: Influenza virus vaccine
0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid
Other Name: Fluzone®

Detailed Description:

The purpose of this clinical trial is to determine, in a relatively small sample of persons 18-49 years of age, if there is a preference trend for a particular route of administration, ID vs IM, when receiving a seasonal influenza vaccine. Uptake of influenza vaccine is disappointingly low in this age group, and there is the perception that aversion to IM injection plays a role in vaccination avoidance. The BD Micro-Injection System to be used in this study may offer a more acceptable alternative to the standard IM injection for influenza immunization and thereby promote wider acceptance of influenza vaccination.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female subject (can have underlying medical condition, as long as they are stable), greater than or equal to 18 to < 50 years of age on the day of inclusion.
  • Informed consent form signed.
  • Able to attend both scheduled visits and to comply with all trial procedures.
  • For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.

Exclusion Criteria:

  • Subject currently breast-feeding.
  • Participation in another investigational clinical trial in the 4 weeks preceding and during the trial period.
  • Hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances.
  • Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  • Any other condition which in the opinion of the Investigator would pose a health risk to the subject or interfere with the evaluation of the vaccine.
  • Personal history of Guillain-Barre syndrome.
  • Current use of alcohol or recreational drugs that in the opinion of the Investigator might interfere with the subject's ability to comply with trial procedures.
  • Febrile illness (oral temperature greater than or equal to 99.5 degrees F) on day of inclusion (temporary deferral).
  • Influenza vaccination received this season (2007-2008).
  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 ClinicalTrials.gov identifier: NCT00623181

Locations
United States, Pennsylvania
Grove City, Pennsylvania, United States, 16127
Pittsburgh, Pennsylvania, United States, 15241
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur, Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00623181     History of Changes
Other Study ID Numbers: FID30
Study First Received: February 6, 2008
Results First Received: July 14, 2011
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Influenza virus

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

ClinicalTrials.gov processed this record on November 25, 2014