NCT00316654

Brief Summary

Persistence of Antibody Response to N. meningitidis Group C in Children

Trial Health

90
On Track

Trial Health Score

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

Enrollment
489

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

Geographic Reach
2 countries

2 active sites

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

February 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2006

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

April 19, 2006

Last Update Submit

July 21, 2017

Conditions

Prevention of Meningococcal Infection

Keywords

Prevention of Meningococcal Meningitisvaccines, conjugateimmunologychildantibody persistence

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA

Secondary Outcomes (2)

  • Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity

  • safety and tolerability

Interventions

Meningococcal C conjugate vaccineBIOLOGICAL

Eligibility Criteria

Age7 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthy children

You may not qualify if:

  • previous ascertained or suspected disease caused by N. meningitidis
  • previous significant acute or chronic infections
  • any other serious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Olsztyn, Lubartów, Kielce, Kraków, Bydgoszcz, Poland

Location

Unknown Facility

Valencia, Spain

Location

MeSH Terms

Interventions

serogroup C meningococcal conjugate vaccine

Study Officials

  • Novartis Vaccines Drug 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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2006

First Posted

April 21, 2006

Study Start

February 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

PL(1)ES(1)