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

Meningococcal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310635
• Other study ID #: M14P1E1
• Secondary ID: Impact N° 1453
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2006
• Last updated: October 25, 2006
• Start date: June 2005

Study information

• Verified date: October 2006
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 32 Months to 40 Months

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Infection
• Meningococcal Infections

Intervention

Biological:
• Meningococcal C conjugate vaccine

Locations

Country	Name	City	State
Germany	Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,	Oppenheim,	Kempten

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determination of antibody titers in naïve control subjects.
Secondary	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.
Secondary	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.