NCT03201211

A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults

A Long-term Follow-up Study of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 51 Years – 73 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Disorders

Interventions

Type	Name	Description
BIOLOGICAL	Blood sampling	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.
BIOLOGICAL	GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.	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.
BIOLOGICAL	GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2.	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.
DRUG	Placebo	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.

Timeline

• Start date: 2017-06-22
• Primary completion: 2020-03-19
• Completion: 2020-03-19
• First posted: 2017-06-28
• Last updated: 2021-04-08
• Results posted: 2021-04-08

Locations

3 sites across 1 country: Belgium

Regulatory

• FDA-regulated drug study