At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Observer-blind, Randomized, Controlled Study to Determine the Immunogenicity and Safety of a Two-dose Regimen of Virosomal Subunit Influenza Vaccine Inflexal V in Healthy Young Children (≥6 Months to ≤35 Months) in Comparison With the Subunit Influenza Vaccine Agrippal
In Brief
A Phase 3 clinical trial evaluating Inflexal V and Agrippal for Influenza. Completed, enrolled 1,356 participants across 1 site.
Detailed Summary
A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.
Study Details
Timeline
Interventions
Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: * 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus * 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus * 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Days 0 and 28
Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: * 15 µg HA antigen of A/Brisbane/59/2007 (H1N1)-like virus * 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus * 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28
Agrippal influenza vaccine Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28