Pfizer’s Phase II trial of meningococcal group B vaccine meets co-primary immunogenicity objectives

The Phase II trial met its co-primary immunogenicity objectives regarding co-administration of Trumenba with MCV4 and Tdap vaccines.

The randomized, controlled, observer-blinded Phase II trial evaluated the safety, tolerability and immunogenicity of Trumenba.

The trial included over 2,600 healthy individuals and group one received Trumenba co-administered with MCV4 and Tdap vaccines, while group two received MCV4 and Tdap vaccines only; with people in the third group received Trumenba only.

Pfizer Vaccine Clinical Research and Development senior vice-president Dr William Gruber said: "Further, the results observed in our Phase II study of Trumenba co-administered with other routine and recommended adolescent vaccines provide important evidence that we’ve shared with the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to review as they consider recommendation of meningococcal B vaccination for adolescents and young adults."

Additionally, data from a recently completed Phase III trial showed the safety and tolerability of Trumenba in about 5,600 healthy individuals 10 through 25 years of age.

Data from the Phase III trial was consistent with data from trials that supported the October 2014 accelerated approval of Trumenba from the US Food and Drug Administration (FDA).

The randomized, controlled, double-blind Phase III trial of Trumenba carried out in the US, Europe, Australia and Chile evaluated the safety and tolerability of the vaccine.