Pfizer reveals results of two meningococcal group B vaccine Phase III studies

23rd August 2015 (Last Updated August 23rd, 2015 18:30)

US-based drugmaker Pfizer has revealed topline results of two Phase III studies of Trumenba (meningococcal group B vaccine).

US-based drugmaker Pfizer has revealed topline results of two Phase III studies of Trumenba (meningococcal group B vaccine).

According to the firm, the two studies reached all primary immunogenicity endpoints, showing better immune responses against certain invasive meningococcal B strains after the vaccine dose series.

One study comprised of around 3,600 healthy individuals aged between ten and 18 years, while the other study included approximately 3,300 healthy individuals aged between 18 and 25 years.

Pfizer vaccine research and development senior vice-president Dr Kathrin Jansen said: "We are very pleased with these Phase III data that show immunogenicity and safety data consistent with findings that formed the basis for the accelerated FDA approval of Trumenba."

"The Phase III data extend the body of evidence that supports vaccination of adolescents and young adults with Trumenba to help prevent serogroup B meningococcal disease."

"The Phase III data extend the body of evidence that supports vaccination of adolescents and young adults with Trumenba."

In October 2014, Trumenba received accelerated approval from the US Food and Drug Administration (FDA) for active immunisation to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged between ten and 25 years of age.

One Phase III was a randomised, active-controlled, and observer-blinded trial, which has been conducted in the US and Europe.

The company randomised the patients to receive one of three different lots of Trumenba in a zero, two, six month schedule or a control.

In the study, the control group secured a licensed hepatitis A (HAV) vaccine at zero and six months and saline at two months and the primary endpoints evaluated immunogenicity, lot consistency, and safety.

The second Phase III randomised, placebo-controlled and observer-blinded study was also carried out in the US and Europe.

In the study, individuals were randomised to receive Trumenba or a saline control in a zero, two, six-month schedule and the primary endpoints assessed immunogenicity and safety.