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CompletedNCT00310635Updated Oct 26, 2006

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

A Phase 4 interventional study of Meningococcal C conjugate vaccine in Meningococcal Infection, sponsored by Novartis. Completed at 1 site in Germany. Open to participants aged 32 Months to 40 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-10-26.

Sponsored by Novartis · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
241
Allocation
Non-randomized
Ages
32 Months to 40 Months
Sex
All
01

Study summary

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

02

Conditions studied

  • Meningococcal Infection

Keywords

  • Prevention of meningococcal infection
03

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 241 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
32 Months to 40 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy children

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
241 participants

Interventions

  • BiologicalMeningococcal C conjugate vaccine
06

What researchers measure

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

  1. Determination of antibody titers in naïve control subjects.

  2. 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.

  3. 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.

07

Study locations

1 site
  • Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,
    Oppenheim,, Kempten, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00310635
Lead sponsor
Novartis
Collaborators
Novartis Vaccines
First posted
Apr 4, 2006
Start date
Jun 2005
Last update
Oct 26, 2006

Study contacts

Vaccines - Information Services
principal investigator · Novartis Vaccines & Diagnostics
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2006. You cannot join it, but the record below documents what was studied.

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