Trials / Completed
CompletedNCT03894969
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
Immunogenicity and Safety Study of GSK's Investigational Vaccine (GSK3277511A) When Administered in Healthy Smokers and Ex-smokers Following Receipt of Shingrix Vaccine
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 541 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-04-23
- Primary completion
- 2020-08-31
- Completion
- 2021-08-13
- First posted
- 2019-03-29
- Last updated
- 2024-09-23
- Results posted
- 2021-09-27
Locations
14 sites across 5 countries: Estonia, Finland, France, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03894969. Inclusion in this directory is not an endorsement.