A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults
Public ClinicalTrials.gov record NCT04886154. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II, Randomised, Controlled Study to Assess the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Adults (Phase I) and to Healthy Adolescents and Adults (Phase II)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04886154
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 1,440 participants
Conditions and interventions
Conditions
Interventions
- MenABCWY-2Gen low dose vaccine Combination Product
- MenABCWY-2Gen high dose vaccine Combination Product
- Placebo Combination Product
- MenB vaccine Combination Product
- MenACWY vaccine Biological
Combination Product · Biological
Eligibility (public fields only)
- Age range
- 10 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 13, 2021
- Primary completion
- Feb 1, 2024
- Completion
- Feb 1, 2024
- Last update posted
- May 30, 2025
2021 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Colorado Springs | Colorado | 80922 | — |
| GSK Investigational Site | Longmont | Colorado | 80501 | — |
| GSK Investigational Site | Doral | Florida | 33175 | — |
| GSK Investigational Site | Miami Lakes | Florida | 33016 | — |
| GSK Investigational Site | Meridian | Idaho | 83642 | — |
| GSK Investigational Site | Nampa | Idaho | 83686 | — |
| GSK Investigational Site | Springfield | Missouri | 65802 | — |
| GSK Investigational Site | Lincoln | Nebraska | 68516 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45219 | — |
| GSK Investigational Site | Charleston | South Carolina | 29414 | — |
| GSK Investigational Site | Nashville | Tennessee | 37212 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04886154, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 30, 2025 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04886154 live on ClinicalTrials.gov.