Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age

Novartis

Status and phase: Completed; Phase 4

Conditions: Meningococcal Infection

Treatments: Biological: Meningococcal C conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00310635

M14P1E1

Impact N° 1453

Details and patient eligibility

About

Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age

Sex: All

Ages: 32 to 40 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children

Exclusion criteria

• known hypersensitivity to any vaccine component
• significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days
• ascertained or suspected disease caused by N. meningitidis
• household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)