drugset / Trial / NCT01111968
Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines
Phase 1
Completed
266 enrolled
Butantan Institute
Hospital Universitario da USP · collabUniversity of Sao Paulo · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.
Timeline
- Start
- 2010-01
- Primary completion
- 2010-12
- Completion
- 2011-03
Outcome
Met primary endpoint
paper Four 2009 influenza A (H1N1) inactivated monovalent candidate vaccines that met the three requirements to evaluate influenza protection, after a single dose, were identified: PMID 21945258 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | pandemic vaccine 1 | Unknown | 7.5 ug | Intramuscular |
| Subject | pandemic vaccine 10 | Unknown | 3.75 ug | Intramuscular |
| Subject | pandemic vaccine 2 | Unknown | 3.75 ug | Intramuscular |
| Subject | pandemic vaccine 5 | Unknown | 7.5 ug | Intramuscular |
| Subject | pandemic vaccine 6 | Unknown | 3.75 ug | Intramuscular |
| Subject | pandemic vaccine 9 | Unknown | 7.5 ug | Intramuscular |
| Subject | pandmeic vaccine 11 | Unknown | 7.5 ug | Intramuscular |
| Subject | pandmeic vaccine 12 | Unknown | 3.75 ug | Intramuscular |
| Subject | pandmic vaccine 13 | Unknown | 15 ug | Intramuscular |