NCT02639351

Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine

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 to Aluminium Hydroxide Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 Years of Age).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R	Intramuscular (IM) vaccination of 1 dose of 0.5 mL
BIOLOGICAL	Investigational MenC-CRM adjuavnted with 25 ug of LHD153R	IM vaccination of 1 dose of 0.5 mL
BIOLOGICAL	Investigational MenC-CRM adjuavnted with 50 ug of LHD153R	IM vaccination of 1 dose of 0.5 mL
BIOLOGICAL	Investigational MenC-CRM adjuavnted with 100 ug of LHD153R	IM vaccination of 1 dose of 0.5 mL
BIOLOGICAL	Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)	IM vaccination of 1 dose of 0.5 mL

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2015-12-24
• Last updated: 2019-06-28
• Results posted: 2019-06-07

Locations

1 site across 1 country: Germany