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

A Phase IV, Multi-Center, Controlled Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Commercially Available Meningococcal C Vaccine When Given as First, Third or Fourth Immunization to Children 32-40 Months of Age

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00310635
Enrollment
241
Registered
2006-04-04
Start date
2005-06-30
Completion date
Unknown
Last updated
2006-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Infection

Keywords

Prevention of meningococcal infection

Brief summary

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

Interventions

BIOLOGICALMeningococcal C conjugate vaccine

Sponsors

Novartis Vaccines
CollaboratorINDUSTRY
Novartis
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
32 Months to 40 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—
Determination of antibody titers in naïve control subjects.—
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.—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026