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OpenTrials
Completed

NCT Number: NCT00310713

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

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

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Key information

Conditions

Prevention of Meningococcal Infection

Age range

12 month–13 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road

Headington, Oxford, OX3 7LJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children

Exclusion criteria

  • Known hypersensitivity to any vaccine products
  • Any immunodeficiency, genetic anomaly or severe acute or chronic illness

Treatment and study plan

Meningococcal C conjugate vaccine

Biological

Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)

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

  1. Immune Response measured 4 weeks after the booster immunisation.

  2. 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.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Apr 4, 2006
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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