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Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Trial sites expanded: 6 → 30 locations
    • Enrollment target: 312 to 305
    • Eligibility criteria expanded, about 32 words
  2. Enrollment target: 302 to 312
    • Study sites: 30 to 6
    • Primary and study completion dates: Feb 5, 2027 to Mar 10, 2027
    v12
  3. Enrollment target: estimated 300 to confirmed 302
    • Study sites: 27 to 30
    • Primary and study completion dates: Feb 26, 2027 to Feb 5, 2027
    • Start date: Dec 29, 2021 to Nov 18, 2021
    v11
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 27 of 27 sites
    v10
  5. Study sites: 30 to 27v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 23 to 30
    • Primary and study completion dates: Dec 11, 2026 to Feb 26, 2027
    v8
  2. Study sites: 22 to 23
    • Primary and study completion dates: Nov 13, 2026 to Dec 11, 2026
    • Eligibility criteria shortened, about 9 words
    v7
  3. Study sites: 19 to 22
    • Primary completion date: Aug 6, 2026 to Nov 13, 2026
    • Study completion date: Aug 7, 2026 to Nov 13, 2026
    v6
  4. Study sites: 13 to 19
    • Primary completion date: Aug 7, 2026 to Aug 6, 2026
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 13
    • Primary and study completion dates: May 29, 2026 to Aug 7, 2026
    • Start date changed from estimate of Nov 29, 2021 to Dec 29, 2021
    v4
  6. Study sites: 0 to 1
    • Start date: Nov 8, 2021 to Nov 29, 2021
    v3
  7. Start date: Oct 18, 2021 to Nov 8, 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GlaxoSmithKline
246 trials monitored
See 20 trials at risk
The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.
Trial Details
NCT Number NCT05087056
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Meningitis, Meningococcal
Related terms Meningitis, Meningococcal
Enrollment 305 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov