Clinical Trial: Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 1, Randomized, Observer-Blind, Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine Compared
Brief Summary: Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 years of age).
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- Solicited local and systemic adverse events (AEs) [ Time Frame: Until Day 14 post-vaccination ]
- Serious adverse event (SAE), Medically attended AEs, AEs leading to study withdraw, New Onset of Chronic Disease (NOCD), Adverse Event of Special Interest (AESI) [ Time Frame: Day 366 ]
- MenC specific functional antibody response (hSBA) [ Time Frame: Day 29 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- MenC specific functional antibody response (hSBA) [ Time Frame: Day 8 and 181 ]
- MenC specific antibody response (ELISA) [ Time Frame: Day 8, 29 and 181 ]
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: December 21, 2015
Date Started: March 2016
Date Completion: August 2017
Last Updated: January 16, 2017
Last Verified: January 2017
