Trials / Completed
CompletedNCT03439657
Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 913 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.
Detailed description
Following the initial approval of the GlaxoSmithKline (GSK) Biologicals' HZ/su vaccine, the protocol was amended to indicate that the trademark is Shingrix. In addition, the term "candidate" vaccine has been replaced by "study" vaccine throughout the protocol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HZ/su vaccine GSK1437173A | 2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm. |
| BIOLOGICAL | Prevenar13 | 1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm. |
Timeline
- Start date
- 2018-04-12
- Primary completion
- 2019-05-06
- Completion
- 2020-03-03
- First posted
- 2018-02-20
- Last updated
- 2022-01-11
- Results posted
- 2021-03-18
Locations
13 sites across 4 countries: United States, Canada, Estonia, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03439657. Inclusion in this directory is not an endorsement.