CClinicalTrials.gg
CompletedNCT00311415Updated Feb 8, 2012

Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children

A Phase 3 interventional study of Meningococcal C conjugate vaccine in Prevention of Meningococcal Infection, sponsored by Novartis Vaccines. Completed at 2 sites in 2 countries. Open to participants aged 7 Weeks to 16 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-08.

Sponsored by Novartis Vaccines · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
257
Allocation
Randomized
Ages
7 Weeks to 16 Weeks
Sex
All
01

Study summary

Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children

Read the detailed description

The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.

02

Conditions studied

  • Prevention of Meningococcal Infection

Keywords

  • Prevention of Meningococcal Meningitis
  • meningococcal vaccines
  • conjugate
  • immunology
  • infant
  • antibody persistence
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 257 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Novartis Vaccines is the lead sponsor of 161 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
7 Weeks to 16 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy infants

Exclusion criteria

Exclusion Criteria:

  • known hypersensitivity to any vaccine component
  • significant acute or chronic infections
  • previously ascertained or suspected disease caused by N. meningitidis
  • previous household contact with an individual with a positive culture of N. meningitidis serogroup C
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
257 participants (actual)

Study arms

  • Experimental
    Group 1: 2+4 Months (2-doses)

    Biological: Meningococcal C conjugate vaccine

  • Experimental
    Group 2: 2 Months (1-dose)

    Biological: Meningococcal C conjugate vaccine

  • Experimental
    Group 3: 6 Months (1-dose)

    Biological: Meningococcal C conjugate vaccine

  • Active comparator
    Group 4: 12-16 Months (1 dose in the second year of life)

    Biological: Meningococcal C conjugate vaccine

Interventions

  • BiologicalMeningococcal C conjugate vaccine

    Meningococcal conjugate vaccine, active comparator. Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age

06

What researchers measure

Primary outcomes

  1. Demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA.

    Time frame: Overall study period

Secondary outcomes

  1. Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA.

    Time frame: Overall study period

07

Study locations

2 sites
  • Mainz, Kehl, Neumünster, Ettenheim, Germany
  • Kraków, Lubartów, Lublin, Bydgosczcz, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00311415
Lead sponsor
Novartis Vaccines
Responsible party
Sponsor
First posted
Apr 6, 2006
Start date
Oct 2005
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Feb 8, 2012

Study contacts

Novartis Vaccines - Information Services
principal investigator · Novartis Vaccines & Diagnostics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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