At a glance
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Immunogenicity and Safety Study of GSK's Investigational Vaccine (GSK3277511A) When Administered in Healthy Smokers and Ex-smokers Following Receipt of Shingrix Vaccine
In Brief
A Phase 2 clinical trial evaluating GSK's investigational non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) multi-antigen vaccine (GSK3277511A) adjuvanted with AS01E and Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine (GSK1437173A) for Respiratory Disorders. Completed, enrolled 541 participants across 14 sites in 5 countries.
Detailed Summary
This study will provide information regarding the sequential administration of two vaccines adjuvanted with AS01. The aim of this study is to understand immunogenicity and safety of NTHi-Mcat vaccine when administered sequentially after Shingrix vaccine and to compare to the immunogenicity of NTHi-Mcat vaccine administered alone. This study will also provide information regarding whether a specific time period is required between the administration of these two different vaccines containing the same adjuvant- AS01 components. The population of this study will include healthy smokers and ex-smokers of 50 to 80 years of age which will be used as a proxy for the COPD population.
Study Details
Timeline
Interventions
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
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