Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe
Completed · Phase 4
Conditions studied: Influenza Prophylaxis
In brief
The primary objective of this study was to evaluate if administration of a seasonal flu vaccine using a jet injector device is comparable to traditional needle and syringe delivery for eliciting an immune response. A secondary objective was to compare the safety of the two delivery methods.
Key facts
- Study ID
- NCT01644149
- Run by
- PharmaJet, Inc.
- People needed
- 83
- Starts
- 2012-01-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2019-06-20
Who can join
Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Female and male subjects ages 18 to 59 years
- Healthy volunteers
- Able to provide informed consent and understand study procedures per ICH/GCP guidelines
- Plans to remain in study area for length of the trial; able to adhere to study visit and follow-up schedule
- Able to complete study diary
You may not qualify if…
- Unwilling or unable to undergo the two blood draws per protocol
- Have received influenza vaccination in the last twelve months
- Have received any vaccination in the last month
- Currently taking antibiotics, steroids, phenytoin, chemotherapy, or other immunosuppressive drugs
- Received recent blood, blood products, or parenteral preparations of immunoglobulin (within 3 months)
- Suffers from allergic reactions to egg, gelatin, or neomycin or has a history of anaphylactic shock, asthma, urticaria, or other allergic reactions to vaccinations.
- Had any serious adverse event associated with a prior vaccination
- Has immunodeficiency or autoimmune disease (including HIV)
- History of chronic alcohol abuse
- Participating in another study concurrently
- Pregnant or breastfeeding during the study
Where it is running
- Bel-Rea Institute — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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