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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: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT04886154 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,440 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2300% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
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 |
What the finished NCT04886154 record still lists
NCT04886154 is an interventional study that assigns participants to a tested intervention. Its 1,440 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2300% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04886154 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04886154's enrollment target sits among peer trials
1,440 3rd of 2000 higher than 1,998 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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