Clinical trial
Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as…
NCT00310804 · Novartis Vaccines, Industry · Completed
Key facts
| NCT number | NCT00310804 |
|---|---|
| Title | Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60) |
| Official title | A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in… |
| Lead sponsor | Novartis Vaccines, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Influenza |
| Intervention type | Biological |
| Interventions | Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV), Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV), Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV), Egg-Derived Trivalent Subunit Influenza Vaccine (TIV) |
| Enrollment | 1,200 |
| Start date | Sep 1, 2005 |
| Primary completion | Oct 1, 2005 |
| Completion | Apr 1, 2006 |
| First posted | Apr 5, 2006 |
| Last update posted | Aug 15, 2019 |
| Countries | Lithuania |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: