Kinetic of Immune Memory Response After Re-Vaccination With Meningococcal Vaccine
This trial is active, not recruiting.
|Condition||meningococcal disease; meningococcal meningitis|
|Treatment||· meningococcal c conjugate vaccine; meningococcal a/c polysaccharide vaccine (partial dose)|
|Start date||September 2003|
|Trial size||264 participants|
|Trial identifier||NCT00262015, M14P2|
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
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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.
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.
Male or female participants from 13 years up to 15 years old.
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
|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®|
|Principal investigator||Andrew J. Pollard, MBBS, FRCPCH, PhD|
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