NCT00310687

Brief Summary

Persistence of Immune response after vaccination with MCC

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,244

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2004

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

Study Start

First participant enrolled

October 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
4 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

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

April 3, 2006

Last Update Submit

September 18, 2014

Conditions

Prevention of Meningococcal Infection

Keywords

Prevention of Meningococcal Meningitisvaccinesconjugateimmunologyantibody persistence

Outcome Measures

Primary Outcomes (1)

  • persistence of memory response to N. meningitidis serogroup C as measured by serum bactericidal activity at one year after either a challenge with 1/5 of a dose of Meningococcal A/C Polysaccharide vaccine or a booster dose of MenC Vaccine.

Secondary Outcomes (2)

  • Evaluation and comparison of the persistence of antibodies against N. meningitidis serogroup C as measured by hBCA

  • Evaluation of the immunological response (ELISA) to N. meningitidis serogroup C

Interventions

BLOOD DRAWPROCEDURE

Eligibility Criteria

Age11 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • healthy adolescents vaccinated with Meningococcal C Conjugate vaccine

You may not qualify if:

  • ascertained or suspected disease caused by N. meningitidis
  • household contact with individuals with proven N. meningitidis serogroup C infection
  • significant acute or chronic infections
  • any other serious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Headington, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

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
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 4, 2006

Study Start

October 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

GB(1)