At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 80 enrolled
Drug / intervention
Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R +4 morebiological
Likely dose
Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 1 clinical trial evaluating Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R, Investigational MenC-CRM adjuavnted with 25 ug of LHD153R, and 3 other interventions for Infections, Meningococcal. Completed, enrolled 80 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartMar 2016
Primary CompletionAug 2017
TodayJul 2026
First PostedDec 24, 2015
Enrollment StartMar 1, 2016
Primary CompletionAug 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.5 years ago
Interventions
Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153Rbiological
Intramuscular (IM) vaccination of 1 dose of 0.5 mL
Investigational MenC-CRM adjuavnted with 25 ug of LHD153Rbiological
IM vaccination of 1 dose of 0.5 mL
Investigational MenC-CRM adjuavnted with 50 ug of LHD153Rbiological
IM vaccination of 1 dose of 0.5 mL
Investigational MenC-CRM adjuavnted with 100 ug of LHD153Rbiological
IM vaccination of 1 dose of 0.5 mL
Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)biological
IM vaccination of 1 dose of 0.5 mL