NCT00262015

Brief Summary

The purpose of this study is to determine when a memory immune response after re-vaccination with Meningococcal C conjugate vaccine (Menjugate) or challenge with Meningococcal A/C polysaccharide vaccine can be observed, after initial vaccination with Meningococcal C conjugate vaccine during the UK immunization campaign

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
Last Updated

December 6, 2005

Status Verified

December 1, 2005

First QC Date

December 2, 2005

Last Update Submit

December 2, 2005

Conditions

Meningococcal Disease; Meningococcal Meningitis

Outcome Measures

Primary Outcomes (1)

  • To measure immunological memory response to N. meningitidis serogroup C after those who received a partial dose of Meningococcal A/C Polysaccharide vaccine and in subjects who received a dose of Chiron Meningococcal C conjugate vaccine.

Secondary Outcomes (1)

  • To assess the immunological response to N. meningitidis serogroup C in those challenged with meningococcal A/C polysaccharide vaccine and in those who received a dose of Chiron Meningococcal C conjugate vaccine.

Interventions

· Meningococcal C conjugate vaccine; Meningococcal A/C Polysaccharide vaccine (partial dose)BIOLOGICAL

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Healthy adolescents between and including 13-15 years of age, who provide written informed consent and who received one immunization with Chiron Meningococcal C Conjugate vaccine (Menjugate) during the UK immunization campaign and for which documentation can be provided.

You may not qualify if:

  • Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford, The Oxford Vaccine Group

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Meningococcal InfectionsMeningitis, Meningococcal

Interventions

serogroup C meningococcal conjugate vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMeningitis, BacterialCentral Nervous System Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Officials

  • Andrew J. Pollard, MBBS, FRCPCH, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 6, 2005

Study Start

September 1, 2003

Last Updated

December 6, 2005

Record last verified: 2005-12

Locations

GB(1)