Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old

EuBiologics

Status and phase: Completed; Phase 1

Conditions: Infection, Meningococcal

Treatments: Biological: EuNmCV-5; Biological: Menveo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05739292

EuVCT_MCV102

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

EuNmCV-5

Experimental group

Description:

Healthy adults received 0.5mL single intramuscular dose on Day 0.

Treatment:

Biological: EuNmCV-5

Menveo

Active Comparator group

Description:

Healthy adults received 0.5mL single intramuscular dose on Day 0.

Treatment:

Biological: Menveo