At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Efgartigimod +2 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 Randomized, Open-label, Placebo-Controlled, Parallel-Group Study to Evaluate the Immune Response to the Polyvalent Pneumococcal Vaccine (PNEUMOVAX 23) in Healthy Participants Receiving Intravenous Efgartigimod or Placebo
In Brief
A Phase 1 clinical trial evaluating Efgartigimod, Placebo, and 1 other intervention for Healthy Volunteers. Completed, enrolled 36 participants across 1 site.
Detailed Summary
This is a randomized, open-label, placebo-controlled phase 1 study in healthy adult volunteers to provide information regarding vaccination with a common pneumococcal polysaccharide vaccine while receiving efgartigimod.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartNov 2021
First PostedDec 2021
Primary CompletionMar 2022
TodayJul 2026
First PostedDec 20, 2021
Enrollment StartNov 17, 2021
Primary CompletionMar 8, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.5 years ago
Interventions
Efgartigimodbiological
intravenous infusion of efgartigimod
Placeboother
intravenous infusion of placebo
PNEUMOVAX 23biological
PNEUMOVAX 23 vaccine