drugset / Trial / NCT00987350
Safety Study of Seasonal Influenza Vaccine by Jet Injection
Phase 4
Completed
60 enrolled
University of Maryland, Baltimore
D'Antonio Consultants International, Inc. · collab
RandomizedParallel-groupQuadruple-blindDevice feasibility
Summary
This research study involves testing of a device that can give injections (shots) without the use of a needle.
Timeline
- Start
- 2010-01
- Primary completion
- 2010-05
- Completion
- 2010-05
Publications
- Background Parent du Chatelet I, Lang J, Schlumberger M, Vidor E, Soula G, Genet A, Standaert SM, Saliou P. Clinical immunogenicity and tolerance studies of liquid vaccines delivered by jet-injector and a new single-use cartridge (Imule): comparison with standard syringe injection. Imule Investigators Group. Vaccine. 1997 Mar;15(4):449-58. doi: 10.1016/s0264-410x(96)00173-9.
- Background Fisch A, Cadilhac P, Vidor E, Prazuck T, Dublanchet A, Lafaix C. Immunogenicity and safety of a new inactivated hepatitis A vaccine: a clinical trial with comparison of administration route. Vaccine. 1996 Aug;14(12):1132-6. doi: 10.1016/0264-410x(96)00044-8.
- Background Williams J, Fox-Leyva L, Christensen C, Fisher D, Schlicting E, Snowball M, Negus S, Mayers J, Koller R, Stout R. Hepatitis A vaccine administration: comparison between jet-injector and needle injection. Vaccine. 2000 Mar 17;18(18):1939-43. doi: 10.1016/s0264-410x(99)00446-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Influenza Virus Vaccine | Vaccine | — | Intramuscular |
Indications
No indication recorded.