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
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
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014