Pfizer's Phase 2 Study Demonstrates Safety, Tolerability and Immunogenicity of TRUMENBA® When Coadministered with Meningococcal A, C, Y and W-135 Polysaccharide Conjugate (MCV4) and Tetanus, Diphtheria and Pertussis (Tdap) Vaccines in Adolescents

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Pfizer Inc.
PFE
announced today that researchers presented for the first time data from a randomized, controlled Phase 2 study of its meningococcal serogroup B vaccine, TRUMENBA®, coadministered with routine meningococcal (groups A, C, Y and W) (MCV4) and tetanus, diphtheria and pertussis (Tdap) vaccines in adolescents. The data, which were released today in an oral presentation at IDWeek 2015TM in San Diego, are based on a study conducted in more than 2,600 healthy individuals 10 through 12 years of age that evaluated the safety, tolerability and immunogenicity of TRUMENBA when coadministered with MCV4 and Tdap. Data demonstrated that immune responses following TRUMENBA, MCV4 and Tdap vaccines given concomitantly were noninferior to immune responses to MCV4 and Tdap alone or TRUMENBA alone. "These Phase 2 data, which are part of a substantial global clinical development program for TRUMENBA, demonstrated that two important routine adolescent vaccines can be coadministrated with TRUMENBA," said Kathrin Jansen, Ph.D., senior vice president of Vaccine Research and Development at Pfizer Inc. "In particular, the convenience associated with coadministration of these recommended vaccines – including allowing for vaccination against five of the most common meningococcal serogroups – is an important factor in helping to protect as many adolescents and young adults as possible from vaccine-preventable diseases." Pfizer's TRUMENBA (Meningococcal Group B Vaccine) is FDA-approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Individuals participating in the study were assigned to one of three groups. Group 1 received TRUMENBA coadministered with MCV4 and Tdap vaccines; Group 2 received MCV4 and Tdap vaccines only; and Group 3 received TRUMENBA only. TRUMENBA immunogenicity was assessed by serum bactericidal assay using human complement (hSBA) with 2 meningococcal serogroup B (MenB) test strains expressing vaccine-heterologous factor H binding protein (fHBP) variants. The immunogenicity of MCV4 and Tdap antigens was assessed utilizing multiplexed Luminex assays and/or serum bactericidal assay using rabbit complement (rSBA). Immune responses following TRUMENBA, MCV4 and Tdap vaccines given concomitantly were noninferior to immune responses to MCV4 and Tdap alone or TRUMENBA alone. Participants in the concomitant control group had hSBA responses to the 2 MenB test strains of 62.3 to 68 percent and 87.5 to 90 percent after 2 and 3 TRUMENBA doses, respectively. The administration of TRUMENBA alone induced similar responses. Coadministration of TRUMENBA, MCV4 and Tdap did not significantly increase local reactions or systemic events compared to TRUMENBA alone.
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