Phase 2
N=110
Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00623181 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination — 85; 75; 4; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluzone: Influenza virus vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination |
85; 75; 4; 2; 44; 35 | — |
| PRIMARY Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination |
2.97; 2.02; 0.79; 0.68; 0.08; 0.05 | — |
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
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).
Data sourced from ClinicalTrials.gov (NCT00623181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.