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

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ClinicalTrials.gov Identifier: NCT00262015
Recruitment Status : Unknown
Verified December 2005 by Chiron Corporation.
Recruitment status was:  Active, not recruiting
First Posted : December 6, 2005
Last Update Posted : December 6, 2005
Sponsor:
Information provided by:
Chiron Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Meningococcal Disease; Meningococcal Meningitis Biological: · Meningococcal C conjugate vaccine; Meningococcal A/C Polysaccharide vaccine (partial dose) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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®
Study Start Date : September 2003





Primary Outcome Measures :
  1. 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 :
  1. 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.


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Ages Eligible for Study:   13 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00262015     History of Changes
Other Study ID Numbers: M14P2
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: December 6, 2005
Last Verified: December 2005

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Meningitis, Meningococcal
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs