Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
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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 |
- 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.
| 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 |
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| United States, Pennsylvania | |
| Grove City, Pennsylvania, United States, 16127 | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| Study Director: | Medical Monitor | Sanofi Pasteur, Inc |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Director, Sanofi Pasteur, Inc |
| 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: | August 10, 2011 |
| 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 May 23, 2013