At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 60 years at time of first vaccination
- ✓Satisfactory baseline medical assessment by history and physical examination
- ✓Female subjects of childbearing potential must have negative pregnancy test on day of vaccination and have practiced adequate contraception for 30 days prior to vaccination
- ✓Able and willing to comply with protocol requirements and maintain telephone contact
- ✕Use of any investigational or non-registered product within 30 days before first dose or during study
- ✕Clinically or virologically confirmed influenza infection within 6 months before study start
- ✕Cancer diagnosis or treatment within 3 years
- ✕Any immunosuppressive or immunodeficient condition including HIV infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunological Non-inferiority Between Two Process-manufactured Influenza Vaccines in Adults Aged 18 to 60 Years
In Brief
A Phase 3 clinical trial evaluating GSK investigational vaccine GSK2340272A for Influenza. Completed, enrolled 300 participants across 4 sites.
Detailed Summary
The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.
Study Details
Timeline
Interventions
One intramuscular injection of initial process-manufactured GSK2340272A vaccine
Two intramuscular injections of initial process-manufactured GSK2340272A vaccine
One intramuscular injection of new process-manufactured GSK2340272A vaccine
Two intramuscular injections of new process-manufactured GSK2340272A vaccine