NCT02290691

Inactivated Influenza Via Jet Injection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 985 (actual)
• Sponsor: PharmaJet, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if the administration of flu vaccine using Needle-Free is equivalent to Needle and Syringe administration as measured by laboratory tests of immune response.

Detailed description

Primary: To evaluate the non-inferiority of flu vaccine administered by needle-free intramuscular (IM) injection versus needle and syringe IM injection as determined with serum hemagglutination inhibition (HAI) reciprocal titers in healthy adults between 18-64 years. Secondary: To compare tolerability and safety of the vaccine in the same population based on specifically solicited local and systemic reactions occurring through 7 days post-immunization and adverse events spontaneously reported through approximately 28 days post immunization.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccine	Influenza Vaccine

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-11-14
• Last updated: 2017-11-30
• Results posted: 2017-11-30

Locations

6 sites across 1 country: United States