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OpenTrials
Completed

NCT Number: NCT00310700

Kinetics of B Cell Response in Infants Menjugate Vaccination

Kinetics of B cell response in infants Menjugate vaccination

Completed

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Key information

Conditions

Prevention of Meningococcal Infection

Age range

8 week–11 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, Oxon, 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 infants

Exclusion criteria

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

Treatment and study plan

Meningococcal C conjugate vaccine

Biological

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

  1. To establish how long the B cells persist in the blood

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

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study title

A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the First and the Third Immunization With Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Infants at 2, 3 and 4 Months of Age

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
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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