Trials / Completed
CompletedNCT00354016
Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects
A Phase III, Multicenter, Uncontrolled, Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 When Administered to Non-Elderly Adult and Elderly Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 125 (planned)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | preservative free inactivated split influenza vaccine using the strain composition 2006/2007 |
Timeline
- Start date
- 2006-07-01
- First posted
- 2006-07-19
- Last updated
- 2007-03-13
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00354016. Inclusion in this directory is not an endorsement.