NCT00310713|CompletedPhase 4

Persistence of Antibodies and Kinetics of B Cell Response in Healthy Children After Vaccination With MCC Vaccine

A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the C Saccharide Component of Chiron's Meningococcal C Conjugate Vaccine Administered to Healthy Children at Least 12 Months of Age After Priming With a Commercially Available Men ACWY Conjugate Vaccine at 2, 3 and 4 Months of Age

Novartis Vaccines ClinicalTrials.gov

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2 other identifiers

M14P5E1Impact N° 1637

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredApr 2006

StartedApr 2006

CompletionAug 2006

Brief Summary

Persistence of antibodies and kinetics of B cell response in healthy children after vaccination with MCC vaccine

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_4

Timeline

Completed

Started Apr 2006

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 months study duration

Study Start

First participant enrolled

April 1, 2006

Completed

2 days 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

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed

Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

April 3, 2006

Last Update Submit

September 18, 2014

Conditions

Prevention of Meningococcal Infection

Keywords

Prevention of Meningococcal Meningitisvaccinesconjugateimmunologychildrenantibody persistence

Outcome Measures

Primary Outcomes (1)

Persistence of memory B cells in the blood at least one year after primary immunisation with MenC Vaccine at 2, 3 and 4 months of age, as determined by meningococcal C specific B-cell ELISPot assay or limiting dilution

Secondary Outcomes (2)

Immune Response measured 4 weeks after the booster immunisation.
establish at which day CRM -197 specific B cells are detectable in the blood after booster immunisation, as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution.