drugset / Trial / NCT01049490
Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination Device
RandomizedParallel-groupSingle-blindPrevention
Summary
Primary objective: To evaluate the safety and immunogenicity of low-dose ID S-OIV H1N1 vaccines delivered via a novel microneedle device (MicronJet600) and compare this to the full-dose standard IM injection. Hypothesis: Low dose (20%) intradermal (ID) S-OIV H1N1 vaccine delivered via a novel microneedle device (MicronJet600) is equally effective as full-dose standard intramuscular (IM) vaccine.
Timeline
- Start
- 2010-01
- Primary completion
- 2010-06
- Completion
- 2010-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | S-OIV H1N1 vaccine | Vaccine | 3 ug | Intramuscular |
| Comparator | S-OIV H1N1 vaccine | Vaccine | 15 ug | Intramuscular |