Phase 4
Completed N=83
Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe
Influenza Prophylaxis
Source: ClinicalTrials.gov NCT01644149 ↗
Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) — 3.55; 3.49; 6.19; 6.13 Titers
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) |
3.55; 3.49; 6.19; 6.13; 3.55; 3.49 | — |
| PRIMARY The Percentage of Participants Achieving Seroconversion |
79.5; 85.0; 89.7; 85.0; 59.0; 65.0 | — |
| SECONDARY Percentage of Subjects With Solicited Local or Systemic Adverse Events |
95; 80; 68; 58; 61; 25 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01644149). 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. Informational only — not medical advice.