Trials / Completed
CompletedNCT03493919
A Sourcing Study to Collect Human Blood Samples From Healthy Adults
A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,021 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study was to collect large volumes of matched pairs of pre- and post-vaccination sera from healthy subjects who administered GlaxoSmithKline (GSK) Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine (Bexsero), which serves for the development, qualification, validation, and maintenance of immunological assays which supports the preclinical research activities and clinical development of GSK Biologicals' vaccines. The safety of the subjects given one of the two vaccines (Bexsero or Menveo), as per the recommended dosage and schedule were assessed during their participation in the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rMenB+OMV NZ vaccine | Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61. |
| BIOLOGICAL | Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) | One dose of MenACWY vaccine were administered intramuscularly at Day 1. |
Timeline
- Start date
- 2018-03-08
- Primary completion
- 2022-05-27
- Completion
- 2022-05-27
- First posted
- 2018-04-11
- Last updated
- 2023-07-17
- Results posted
- 2023-07-17
Locations
6 sites across 2 countries: Australia, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03493919. Inclusion in this directory is not an endorsement.