Meningitis Clinical Trial
Official title:
Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A
and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.
Primary objective:
- To demonstrate the non-inferiority of the antibody responses to meningococcal
serogroups A, C and Haemophilus influenzae type b following the administration of
adjuvant-free MenAC-Hib conjugate vaccine compared to those observed following the
administration of adjuvant MenAC-Hib conjugate vaccine.
- To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to
that of adjuvant MenAC-Hib conjugate vaccine.
Secondary objective:
•To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae
type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those
observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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