Kinetic of Immune Memory Response After Re-Vaccination With Meningococcal Vaccine
Sponsor
Chiron Corporation (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00262015
Collaborator
(none)
264
1
Study Details
Study Description
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 |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
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
:
Sep 1, 2003
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
13 Years
to 15 Years
Sexes Eligible for Study:
All
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00262015
Other Study ID Numbers:
- M14P2
First Posted:
Dec 6, 2005
Last Update Posted:
Dec 6, 2005
Last Verified:
Dec 1, 2005
Additional relevant MeSH terms: