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NCT02986854 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 704
- Enrollment target
NCT02986854: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02986854 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 704 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02986854, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 704 participants
- Enrollment target
Study Summary
The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects
Primary Outcome
Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers\< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo \&,if met,also in group of subjects who received primary vaccination with Menactra.Immune
Interventions
- BIOLOGICAL Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 704 participants |
| Start Date | 2016-12-08 |
| Est. Completion | 2017-12-07 |
| Phase | Phase 3 |
What the finished NCT02986854 record still lists
NCT02986854 is an interventional study that assigns participants to a tested intervention. The registered 704 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo) is the first listed.
NCT02986854 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02986854 about?
NCT02986854 is a clinical study titled "Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination". The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects
What is the current status of trial NCT02986854?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 704 participants. The study started on 2016-12-08. Estimated completion is 2017-12-07.
What interventions are being tested in trial NCT02986854?
The interventions under investigation include: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02986854?
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 NCT02986854's enrollment target sits among peer trials
704 506th of 2000 higher than 1,495 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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