NCT00310700

Brief Summary

Kinetics of B cell response in infants Menjugate vaccination

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
5 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

6 months

First QC Date

April 3, 2006

Last Update Submit

September 18, 2014

Conditions

Prevention of Meningococcal Infection

Keywords

Prevention of Meningococcal Meningitisvaccines, conjugateimmunologyinfantantibody persistence

Outcome Measures

Primary Outcomes (1)

  • To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay.

Secondary Outcomes (3)

  • To establish how long the B cells persist in the blood

  • To note the difference between plasma cell response following the first and third MenC vaccination.

  • To determine the immune response to Neisseria meningitidis serogroup C 26-34 days after the third immunisation

Interventions

Meningococcal C conjugate vaccineBIOLOGICAL

Eligibility Criteria

Age8 Weeks - 11 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy infants

You may not qualify if:

  • previously ascertained or suspected disease caused by N. meningitidis
  • previous household contact with an individual with a positive culture of N. meningitidis serogroup C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, Oxon, OX3 7LJ, United Kingdom

Location

Related Publications (1)

  • Kelly DF, Snape MD, Perrett KP, Clutterbuck EA, Lewis S, Blanchard Rohner G, Jones M, Yu LM, Pollard AJ. Plasma and memory B-cell kinetics in infants following a primary schedule of CRM 197-conjugated serogroup C meningococcal polysaccharide vaccine. Immunology. 2009 May;127(1):134-43. doi: 10.1111/j.1365-2567.2008.02934.x.

    PMID: 19175802BACKGROUND

MeSH Terms

Interventions

serogroup C meningococcal conjugate vaccine

Study Officials

  • Novartis 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

May 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

GB(1)