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

Phase 4CompletedNCT00310635

Novartis241 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

241

Conditions

Meningococcal Infection

Interventions

Meningococcal C conjugate vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 32 MonthsMax age: 40 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,

Oppenheim, Kempten, Germany

Outcomes

Primary Outcomes

Determination of memory antibody response to Neisseria meningitidis serogroup C after 2 or 3 doses of MenC vaccine given during infancy, as measured by hBCA at day 0 and day 28.

Secondary Outcomes

Determination of antibody titers in naïve control subjects.

Determination of persistence of antibody response after either 2 or 3 doses of MenC vaccine given during infancy and one dose of MenPS A/C vaccine given at 12 months of age.

Evaluation of the safety and tolerability of a single 0.5 mL intramuscular (IM) injection of MenC Vaccine when given to children approximately three years of age.

Data from ClinicalTrials.gov

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