CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 120 enrolled
Drug / intervention
Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A +3 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.

Search/NCT02547974
NCT02547974Phase 1Completed

An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults.

GlaxoSmithKline·interventional·Posted Sep 14, 2015·Updated Aug 31, 2018

In Brief

A Phase 1 clinical trial evaluating Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A, Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A, and 2 other interventions for Respiratory Disorders. Completed, enrolled 120 participants across 3 sites.

Detailed Summary

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK Biologicals' GSK3277511A vaccine in adults

Study Details

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

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 14, 2015
Enrollment StartAug 31, 2015
Primary CompletionMar 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.8 years ago

Interventions

Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513Abiological

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513Abiological

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036Abiological

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

Placebodrug

2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule