Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years - Trial NCT01928472
Access comprehensive clinical trial information for NCT01928472 through Pure Global AI's free database. This Phase 1 trial is sponsored by Novartis Vaccines and is currently Completed. The study focuses on H7N9 Influenza. Target enrollment is 402 participants.
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Study Focus
Sponsor & Location
Novartis Vaccines
Novartis
Timeline & Enrollment
Phase 1
Aug 01, 2013
Sep 01, 2014
Primary Outcome
Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43),Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43),Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43),Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43),Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine,Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine,Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Summary
Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults
 between the ages of 18 years and 65 years.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT01928472
Non-Device Trial