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NCT04318548 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 945
- Enrollment target
NCT04318548 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 945 participants.
The verdict
NCT04318548, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 945 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.
Interventions
- COMBINATION_PRODUCT Placebo
- COMBINATION_PRODUCT Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)
- BIOLOGICAL Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 945 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2023-11-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04318548
The ClinicalTrials.gov registry entry for NCT04318548 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 945 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 3 interventions - of which Placebo is the first listed.
NCT04318548 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04318548 about?
NCT04318548 is a clinical study titled "Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age". The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.
What is the current status of trial NCT04318548?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 945 participants. The study started on 2020-08-25. Estimated completion is 2023-11-21.
What interventions are being tested in trial NCT04318548?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) (COMBINATION_PRODUCT), Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04318548?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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