At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 100 enrolled
Drug / intervention
ExPEC4V +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Immunogenicity of the ExPEC4V (JNJ-63871860) Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Subjects Aged 18 Years and Older
In Brief
A Phase 2 clinical trial evaluating ExPEC4V and Placebo for Healthy. Completed, enrolled 100 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day 15).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartMay 2018
Primary CompletionNov 2018
Study CompletionJun 2019
TodayJul 2026
First PostedApr 18, 2018
Enrollment StartMay 9, 2018
Primary CompletionNov 5, 2018
Study CompletionJun 11, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.2 years ago
Interventions
ExPEC4Vbiological
Participants will receive ExPEC4V vaccine as an IM injection on Days 1 and 181.
Placebobiological
Participants will receive placebo as an IM injection on Days 1 and 181.