drugset / Trial / NCT00814229
Safety and Immunogenicity of Influenza H9 Vaccine in Humans
Phase 1
Completed
353 enrolled
University Hospitals, Leicester
Crucell Holland BV · collabNational Institute of Biological Standards and Control · collabPublic Health England · collab
RandomizedSingle-groupTriple-blindBasic science
Summary
H9N2 influenza circulates in animal and poultry and has caused delf limiting infections in children. Influenza H9N2 poses a pandemic threat to humans. This study evaluates the safety and immunogenicity of adjuvanted and non-adjuvanted whole virus and virosomal H9N2 vaccines by the intramuscular route. We also assess intradermal route of administration to see if this has any advantages. The aim is to assess antibody responses before and after vaccination. The hypothesis is that lower doses of adjuvanted vaccine will induce similar antibody responses to non-adjuvanted vaccine
Timeline
- Start
- 2007-08
- Primary completion
- 2008-01
- Completion
- 2008-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | H9N2 virosome vaccine | Vaccine | 1.5 ug | Intramuscular |
| Comparator | H9N2 virosome vaccine | Vaccine | 5 ug | Intramuscular |
| Comparator | H9N2 virosome vaccine | Vaccine | 15 ug | Intramuscular |
| Comparator | H9N2 virosome vaccine | Vaccine | 45 ug | Intramuscular |
| Comparator | H9N2 whole virus vaccine | Vaccine | 1.5 ug | Intramuscular |
| Comparator | H9N2 whole virus vaccine | Vaccine | 5 ug | Intramuscular |
| Comparator | H9N2 whole virus vaccine | Vaccine | 5 ug | Other |
| Comparator | H9N2 whole virus vaccine | Vaccine | 15 ug | Intramuscular |
| Comparator | H9N2 whole virus vaccine | Vaccine | 15 ug | Other |
| Comparator | H9N2 whole virus vaccine | Vaccine | 45 ug | Intramuscular |
| Comparator | H9N2 whole virus vaccine, alum | Vaccine | 1.5 ug | Intramuscular |
| Comparator | H9N2 whole virus vaccine, alum | Vaccine | 5 ug | Intramuscular |
| Comparator | H9N2 whole virus vaccine, alum | Vaccine | 15 ug | Intramuscular |
| Comparator | H9N2 whole virus vaccine, alum | Vaccine | 45 ug | Intramuscular |