Date: 2015-10-09
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at IDWeek 2015 in San Diego
Company: Pfizer (USA - NY)
Product: Trumenba® - rLP2086 coadministered with routine meningococcal (groups A, C, Y and W) (MCV4) and tetanus, diphtheria and pertussis (Tdap) vaccines
Action
mechanism:
- vaccine. This investigational meningococcal B vaccine targets LP2086, or factor H binding protein, which is found on the surface of the meningococcal B bacterium. The gene for factor H binding protein is present in more than 1,800 meningococcal B isolates studied by Pfizer researchers. The vaccine contains two recombinant versions of the LP2086 antigen, one representative for each of the two known genetic subfamilies of the antigen, subfamily A and subfamily B.
- Trumenba® (Meningococcal Group B Vaccine) is indicated in the US for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. In 2014, this vaccine was reviewed and received accelerated approval under the FDA\'s Breakthrough Therapy designation and Priority Review programs.
Disease:
Therapeutic
area: Infectious diseases
Country: USA
Trial
details: Vaccine safety, tolerability and immunogenicity were evaluated in this Phase 2, randomized, controlled, observer-blinded study of Trumenba® in the United States. The study included more than 2,600 healthy individuals 10 through 12 years of age. Group 1 received Trumenba® coadministered with MCV4 and Tdap vaccines; Group 2 received MCV4 and Tdap vaccines only; and Group 3 received Trumenba® only.
Co-primary objectives included:
- Demonstration that the immune response induced by MCV4 and Tdap vaccines given with Trumenba® was noninferior to the immune response induced by MCV4 and Tdap vaccines alone when measured one month after the first vaccination;
- Demonstration that the immune response induced by Trumenba® given with MCV4 and Tdap vaccines was noninferior to the immune response induced by
Latest
news:
- • On October 9, 2015, Pfizer announced 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 in an oral presentation at IDWeek 2015 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. 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.
Is
general: Yes
