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
1 other identifier
interventional
110
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2008
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 6, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
August 11, 2011
CompletedApril 14, 2016
April 1, 2016
4 months
February 6, 2008
July 14, 2011
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Days 0 through 7 post-vaccination
Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
Days 0 through 7 post-vaccination
Study Arms (2)
Fluzone Intradermal First, Then Fluzone Intramuscular
EXPERIMENTALFluzone Intramuscular First, Then Fluzone Intradermal
EXPERIMENTALInterventions
0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Influenza vaccination received this season (2007-2008).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Grove City, Pennsylvania, 16127, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15241, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Sanofi Pasteur, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2008
First Posted
February 25, 2008
Study Start
January 1, 2008
Primary Completion
May 1, 2008
Study Completion
June 1, 2008
Last Updated
April 14, 2016
Results First Posted
August 11, 2011
Record last verified: 2016-04