At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
In Brief
A Phase 1 clinical trial evaluating ExPEC10V, ExPEC4V, and 2 other interventions for Extraintestinal Pathogenic Escherichia Coli Prevention. Completed, enrolled 836 participants across 29 sites in 5 countries.
Detailed Summary
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.
Study Details
Timeline
Arms & Interventions
Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.
Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.
Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.
Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.
Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.
Participants will be randomized to receive a single IM injection of selected dose of ExPEC10V on Day 1. The ExPEC10V dose used in Cohort 2 will be based on the primary analysis (Day 30) results of Cohort 1.
Participants will be randomized to receive a single IM injection of matching placebo on Day 1.
Interventions
Participants will receive a single IM injection of ExPEC10V (1 of 3 doses \[low or medium or high\]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.
Participants will receive a single IM injection of ExPEC4V on Day 1.
Participants will receive a single IM injection of Prevnar 13 on Day 1.
Participants will receive single IM injection of matching placebo on Day 1.