Kinetic of Immune Memory Response After Re-Vaccination With Meningococcal Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Chiron Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Chiron Corporation
ClinicalTrials.gov Identifier:
NCT00262015
First received: December 2, 2005
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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


Condition Intervention Phase
Meningococcal Disease; Meningococcal Meningitis
Biological: · Meningococcal C conjugate vaccine; Meningococcal A/C Polysaccharide vaccine (partial dose)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase IV, Single Center, Open-Label, Controlled, Randomized Study to Evaluate the Memory Response of Children Previously Vaccinated With Chiron Meningococcal C Conjugate Vaccine, Menjugate® and Describe the Kinetic of the Antibody Response and Maturation on Days 2-7 and 28 After Challenge With Pasteur Merieux Meningococcal A/C Polysaccharide Vaccine or Menjugate®

Resource links provided by NLM:


Further study details as provided by Chiron Corporation:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 264
Study Start Date: September 2003
  Eligibility

Ages Eligible for Study:   13 Years to 15 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262015

Locations
United Kingdom
University of Oxford, The Oxford Vaccine Group
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Chiron Corporation
Investigators
Principal Investigator: Andrew J. Pollard, MBBS, FRCPCH, PhD University of Oxford
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00262015     History of Changes
Other Study ID Numbers: M14P2
Study First Received: December 2, 2005
Last Updated: December 2, 2005
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on April 15, 2014