At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized Double-blind Controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of ExPEC9V and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older
In Brief
A Phase 3 clinical trial evaluating ExPEC9V, Placebo, and 1 other intervention for Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention. Completed, enrolled 959 participants across 41 sites in 4 countries.
Detailed Summary
The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD QIV given alone and further show that ExPEC9V given together with HD QIV does not induce lower antibody response against each of the vaccine O-serotype antigens, as compared to ExPEC9V given alone.
Study Details
Timeline
Interventions
ExPEC9V will be administered as an IM injection.
Placebo will be administered as an IM injection.
HD quadrivalent influenza vaccine will be administered as IM injection.