CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 81 enrolled
Drug / intervention
Blood sampling +3 morebiological
Likely dose
GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03201211
NCT03201211Phase 1Completed
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A Long-term Follow-up Study of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults

GlaxoSmithKline·interventional·Posted Jun 28, 2017·Updated Apr 8, 2021

In Brief

A Phase 1 clinical trial evaluating Blood sampling, GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2., and 2 other interventions for Respiratory Disorders. Completed, enrolled 81 participants across 3 sites.

Detailed Summary

The purpose of this long-term follow-up of a Phase I study is to evaluate the kinetics of the antibody response to NTHi-Mcat antigens and long-term safety, in subjects aged between 50-71 years at the time of enrolment in the NTHi-Mcat-001 study. These subjects were previously exposed to two adjuvanted formulations of the NTHi-Mcat vaccine administered according to a 0, 2 months schedule in the NTHi-Mcat-001 (201281) study. The subjects that had received saline placebo controls will also be included in this follow-up study to make comparisons with the investigational vaccines. No vaccinations will be administered in this trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Disorders
CountriesBelgium
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJun 28, 2017
Enrollment StartJun 22, 2017
Primary CompletionMar 19, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.0 years ago

Interventions

Blood samplingbiological

A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.

GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.biological

2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2.biological

2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Placebodrug

2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.