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OpenTrials
Completed

NCT Number: NCT00310687

Persistence of Immune Response After Vaccination With MCC

Persistence of Immune response after vaccination with MCC

Completed

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Key information

Conditions

Prevention of Meningococcal Infection

Age range

11 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Headington, Oxfordshire, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy adolescents vaccinated with Meningococcal C Conjugate vaccine

Exclusion criteria

  • ascertained or suspected disease caused by N. meningitidis
  • household contact with individuals with proven N. meningitidis serogroup C infection
  • significant acute or chronic infections
  • any other serious disease

Treatment and study plan

Blood draw

Procedure

Primary outcomes

  1. persistence of memory response to N. meningitidis serogroup C as measured by serum bactericidal activity at one year after either a challenge with 1/5 of a dose of Meningococcal A/C Polysaccharide vaccine or a booster dose of MenC Vaccine.

Secondary outcomes

  1. Evaluation and comparison of the persistence of antibodies against N. meningitidis serogroup C as measured by hBCA

  2. Evaluation of the immunological response (ELISA) to N. meningitidis serogroup C

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study title

A Phase IV, Single Centre, Open-label Study to Evaluate the Persistence of Antibodies in Adolescents 14-16 Years of Age, Vaccinated With Chiron Meningococcal C Conjugate Vaccine During the 1999-2001 UK MenCC Immunization Campaign, at One Year After Either a Challenge Dose of Aventis Pasteur MSD Meningococcal A/C Polysaccharide Vaccine or a Booster Dose of MenC Vaccine, in Parallel to Subjects Aged 11-20 Evaluated at 4 Years After Vaccination During the 1999-2001 UK MenCC Immunization Campaign

Important dates

Study start
2004
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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