A Single Center, Randomized, Observer-blinded, Active Comparator Phase I Study to Assess the Safety and Immunogenicity of Meningococcal (Groups A, C, W-135, X and Y) Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old

EuVCT_MCV102

Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, X, and Y)-CRM197 Conjugate vaccine

2023-02-28

2023-05-10

2023-10-04

Completed

Early phase I

60

Inclusion Criteria: * Subjects 19 to 55 years of age * Written informed consent * Available for all visits and telephone calls scheduled for the study Exclusion Criteria: * Previous or suspected disease caused by N. meningitides * Household and/or intimate exposure to an individual with culture-proven N. meningitides infection within 60 days prior to screening * Serious acute, chronic or progressive disease as determined by investigator * History of alcohol or substance abuse

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-12-20