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

Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Fluzone: Influenza virus vaccine; Biological: Fluzone: Influenza virus vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Grove City, Pennsylvania, United States, 16127
    • Pittsburgh, Pennsylvania, United States, 15241

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Fluzone®; Biological: Fluzone: Influenza virus vaccine; 0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid; Other Names: Fluzone®
Experimental: Fluzone Intramuscular First, Then Fluzone Intradermal	Biological: Fluzone: Influenza virus vaccine; 0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid; Other Names: Fluzone®; Biological: Fluzone: Influenza virus vaccine; 0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid; Other Names: Fluzone®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination	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.	Day 0 and up to 7 days post-vaccination
Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination	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.	Days 0, 3, and 7 after vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection	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.	Days 0 through 7 post-vaccination
Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection	Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia. Data for this outcome were based on the first vaccination type, intradermal or intramuscular.	Days 0 through 7 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Medical Monitor, Sanofi Pasteur, Inc

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: February 6, 2008
• First Submitted That Met QC Criteria: February 22, 2008
• First Posted (Estimate): February 25, 2008

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Influenza; Influenza virus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FID30