A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years
Phase of Trial: Phase III
Latest Information Update: 23 Apr 2018
At a glance
- Drugs PF 5212366 (Primary) ; Hepatitis A vaccine inactivated
- Indications Hepatitis A; Meningococcal group B infections
- Focus Adverse reactions; Registrational
- Sponsors Pfizer
- 23 Apr 2018 According to Pfizer media release, the company received traditional approval for TRUMENBA (Meningococcal Group B Vaccine) from the FDA in individuals 10 to 25 years of age for the three-dose schedule based data from this study.
- 30 May 2017 According to a Pfizer media release, the European Commission (EC) has approved TRUMENBA (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older. Results from this study supported the approval.
- 01 Feb 2016 Results published in the Vaccine