NCT03894969 - Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine | Biotech Hunter

Enrollment

541

Participants

Timeline

Start Date

April 23, 2019

Primary Completion Date

August 31, 2020

Study Completion Date

August 13, 2021

Conditions

Respiratory Disorders

Interventions

BIOLOGICAL

GSK's investigational non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) multi-antigen vaccine (GSK3277511A) adjuvanted with AS01E

2 doses of the investigational NTHi-Mcat vaccine will be administered 2 months apart to all subjects in all the groups. The vaccine will be given intramuscularly (IM) in the upper deltoid of non-dominant arm

BIOLOGICAL

Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine (GSK1437173A)

2 doses of the Shingrix vaccine will be administered at days 1 and 61 to all subjects in groups Sh\_NTHi-Mcat\_1, 3 and 6. The vaccine will be given intramuscularly (IM) in the upper deltoid of the non-dominant arm

Trial Locations (14)

10117

GSK Investigational Site, Tallinn

20100

GSK Investigational Site, Turku

28006

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

34295

GSK Investigational Site, Montpellier

35033

GSK Investigational Site, Rennes

37134

GSK Investigational Site, Verona

40100

GSK Investigational Site, Jyväskylä

50106

GSK Investigational Site, Tartu

51014

GSK Investigational Site, Tartu

56126

GSK Investigational Site, Pisa

75679

GSK Investigational Site, Paris

00029

GSK Investigational Site, Helsinki

FI-33100

GSK Investigational Site, Tampere