At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity (in a Subset) Following a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects Who Received Either One or the Other Vaccine One Year Before in the V58P4 Study.
In Brief
A Phase 3 clinical trial evaluating Cell culture derived influenza vaccine and egg-derived influenza subunit vaccine for Influenza. Completed, enrolled 2,235 participants across 5 sites.
Detailed Summary
The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.
Study Details
Timeline
Interventions
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm