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NCT04886154 · ClinicalTrials.gov registry record · Phase 1
A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,440
- Enrollment target
NCT04886154 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,440 participants.
The verdict
NCT04886154, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,440 participants
- Enrollment target
Study Summary
The purpose of this study was to assess the safety, effectiveness, and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of this study was conducted in healthy adults in a dose-escalating fashion with 2 formulations of the investigational MenABCWY-2Gen vaccine and served as a safety lead-in to the Phase II study. The Phase II part of the study was conducted in 2 parts: The 'formulation and schedule-finding' part followed in healthy adolescents and young adults and was designed to select the vaccine formulation and the schedule to be tested in Phase III. The 'blood sourcing' part was conducted in healthy adults in order to collect sufficient serum samples for the development of assays to be used in the MenABCWY-2Gen vaccine clinical development program.
Interventions
- COMBINATION_PRODUCT Placebo
- BIOLOGICAL MenACWY vaccine
- COMBINATION_PRODUCT MenB vaccine
- COMBINATION_PRODUCT MenABCWY-2Gen low dose vaccine
- COMBINATION_PRODUCT MenABCWY-2Gen high dose vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,440 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2024-02-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04886154
The ClinicalTrials.gov registry entry for NCT04886154 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1,440 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04886154 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04886154 about?
NCT04886154 is a clinical study titled "A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults". The purpose of this study was to assess the safety, effectiveness, and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of ...
What is the current status of trial NCT04886154?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,440 participants. The study started on 2021-06-14. Estimated completion is 2024-02-02.
What interventions are being tested in trial NCT04886154?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), MenACWY vaccine (BIOLOGICAL), MenB vaccine (COMBINATION_PRODUCT), MenABCWY-2Gen low dose vaccine (COMBINATION_PRODUCT), MenABCWY-2Gen high dose vaccine (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04886154?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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