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IDWeek 2015′ten: Menactra ve Adacel’le Birlikte Uygulanan Trumenba’nın Etkinliği ve Güvenliği Kanıtlandı


Infectious Diseases Society of America (IDSA)’nın düzenlediği IDWeek 2015™’de sunulan verilere göre Menactra ve Adacel aşılarıyla eşzamanlı olarak uygulanan Trumenba, eşdeğerlik için gerekli olan tüm immünojenisite kriterlerini karşılıyor.

Trumenba found safe, effective when administered with Menactra, Adacel


October 9, 2015

SAN DIEGO — Trumenba met all noninferiority immunogenicity criteria when concomitantly administered with Menactra and Adacel vaccines, according to data presented at IDWeek 2015.

“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,” Kathrin U. Jansen, PhD, senior vice president of vaccine research and development at Pfizer, said in a news release. “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.”

The researchers studied a cohort of 2,648 patients, aged 10 to 12 years, who were randomly assigned to three study groups. The first group received Trumenba (bivalent rLP2086 meningococcal group B vaccine, Pfizer) concomitantly with Menactra (meningococcal ACYW-135 conjugate vaccine, Sanofi Pasteur; MCV4) and Adacel (Tdap, Sanofi Pasteur); the second group received only MCV4 and Tdap; and the third group received only meningococcal group B vaccine. Meningococcal group B immunogenicity levels were confirmed via serum bactericidal assay using human complement (hSBA).

Study results showed that immune responses in the concomitant group were noninferior to the immune responses in both groups where the vaccines were administered alone. Participants in the concomitant group had hSBA responses of 62.3% to 68% after two doses, and 87.5% to 90% after three doses. These results were similar to those in the meningococcal serogroup B vaccine only group of 66% to 68% after two doses, and 91.4% to 92.7% after three doses.

The researchers also wrote that meningococcal group B vaccine is safe and well-tolerated when coadministered with MCV4 and Tdap. Administering the vaccines together did not significantly increase local reactions or systemic events when compared with meningococcal group B vaccine alone.

“Convenience associated with concomitant administration of vaccines recommended for use in adolescents and young adults may improve adherence to recommended schedules,” study researcher Derek Muse, MD, of Jean Brown Research, Utah, and colleagues wrote. – by David Costill

Reference:
Muse D, et al. Oral Abstract 745. Presented at: IDWeek; Oct. 7-11, 2015; San Diego.

Disclosures: Jansen is an employee and shareholder of Pfizer. Muse reports no relevant financial disclosures.