Back to resultsStudy to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluzone: Influenza virus vaccine
Fluzone: Influenza virus vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Influenza virus
Eligibility 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fluzone Intradermal First, Then Fluzone Intramuscular
Fluzone Intramuscular First, Then Fluzone Intradermal
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00623181
First Posted
February 6, 2008
Last Updated
April 12, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00623181
Brief Title
Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
Official Title
Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Influenza virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluzone Intradermal First, Then Fluzone Intramuscular
Arm Type
Experimental
Arm Title
Fluzone Intramuscular First, Then Fluzone Intradermal
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Fluzone: Influenza virus vaccine
Other Intervention Name(s)
Fluzone®
Intervention Description
0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid
Intervention Type
Biological
Intervention Name(s)
Fluzone: Influenza virus vaccine
Other Intervention Name(s)
Fluzone®
Intervention Description
0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid
Primary Outcome Measure Information:
Title
Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Description
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.
Time Frame
Day 0 and up to 7 days post-vaccination
Title
Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Description
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.
Time Frame
Days 0, 3, and 7 after vaccination
Other Pre-specified Outcome Measures:
Title
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Description
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.
Time Frame
Days 0 through 7 post-vaccination
Title
Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
Description
Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia.
Data for this outcome were based on the first vaccination type, intradermal or intramuscular.
Time Frame
Days 0 through 7 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Sanofi Pasteur, Inc
Official's Role
Study Director
Facility Information:
City
Grove City
State/Province
Pennsylvania
ZIP/Postal Code
16127
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
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Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
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