Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children
The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
257
Meningococcal conjugate vaccine, active comparator. Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age
Unnamed facility
Mainz, Kehl, Neumünster, Ettenheim, Germany
Unnamed facility
Kraków, Lubartów, Lublin, Bydgosczcz, Poland
Demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA.
Time frame: Overall study period
Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA.
Time frame: Overall study period
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