A Study to Test if a Third Dose of the Vaccine is Safe in Current and Former Smokers Aged 40 to 80 Years Old and to Gather Information on the Immune Response Following the Third Dose of the Vaccine

PHASE2CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 20, 2018

Primary Completion Date

December 31, 2019

Study Completion Date

September 23, 2020

Conditions
Respiratory Disorders
Interventions
BIOLOGICAL

NTHi Mcat investigational vaccine (GSK3277511A)

Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm and a third dose administered at either Day 181 or Day 361, according to each vaccination scheduling defined per protocol.

BIOLOGICAL

Placebo

One dose administered intramuscularly at either Day 181 or Day 361 in the deltoid region of the non-dominant arm.

Trial Locations (8)

47574

GSK Investigational Site, Goch

97070

GSK Investigational Site, Würzburg

B2N 1L2

GSK Investigational Site, Truro

J1J 2G2

GSK Investigational Site, Sherbrooke

S40 4AA

GSK Investigational Site, Chesterfield

NN8 4RW

GSK Investigational Site, Wellingborough

BS26 2BJ

GSK Investigational Site, Axbridge, Somerset

SN15 2SB

GSK Investigational Site, Chippenham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03443427 - A Study to Test if a Third Dose of the Vaccine is Safe in Current and Former Smokers Aged 40 to 80 Years Old and to Gather Information on the Immune Response Following the Third Dose of the Vaccine | Biotech Hunter | Biotech Hunter