NCT00310635

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
Last Updated

October 26, 2006

Status Verified

October 1, 2006

First QC Date

April 3, 2006

Last Update Submit

October 25, 2006

Conditions

Meningococcal Infection

Keywords

Prevention of meningococcal infection

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • 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.

Interventions

Meningococcal C conjugate vaccineBIOLOGICAL

Eligibility Criteria

Age32 Months - 40 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Oppenheim, Kempten, Germany

Location

MeSH Terms

Conditions

Meningococcal Infections

Interventions

serogroup C meningococcal conjugate vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Vaccines - Information Services

    Novartis Vaccines & Diagnostics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 4, 2006

Study Start

June 1, 2005

Last Updated

October 26, 2006

Record last verified: 2006-10

Locations

DE(1)