B1971009 Phase 3 study to assess Meningococcal B Vaccine

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Active-Controlled, Observer-Blinded Trial to Assess the Lot Consistency, Safety, Tolerability, and Immunogenicity of a Meningococcal Serogroup B Bivalent Rlp2086 Vaccine in Healthy Subjects Aged =10 to <19 Years

• IRAS ID

  86607

• Contact name

  Robert Read

• Sponsor organisation

  Pfizer Inc 235 East 42nd Street NY 10017

• Eudract number

  2010-023873-20

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Neisseria meningitidis is a leading cause of bacterial meningitis in infants, adolescents, and young adults in developed countries. In particular, N. meningitidis serogroup B (MnB) is responsible for approximately two-thirds of the cases of observed meningococcal infections in Europe, with a fatality rate of 6% to 10% in 2006. The likelihood of experiencing meningococcal B disease for any individual is very low. Adolescents however have somewhat of an increased risk of disease compared to the general population. Vaccines are available to help fight off the other types of meningococcus germ, but not meningococcus B. This study is being undertaken to look at a new vaccine rLP2086 to prevent MnB disease. There will be approximately 3752 healthy adolescents (11 to 18 year olds) enrolled in the study at approximately 125 different research sites in a number of countries across Europe and North America. This study will use competitive enrollment. This means that when a certain number of adolescents have entered the study from all the research sites combined, no more participants will be enrolled at any site. Subjects will be in this study for approximately 14 months, and will need to visit the research site at least 5 times during the study. The amount of antibody subjects make after having shots of test vaccine will be measured (immunogenicity) and whether people receiving different lots of test vaccine make similar amounts of antibody. The safety and tolerability of rLP2086 vaccine will also be assessed. Subjects will be placed into 1 of 4 groups decided by a randomisation process and will either receive one of three lots of rLP2086 vaccine or the comparator Havrix©, a licensed vaccine approved for the prevention of Hepatitis A disease. The study will also provide information about the consistency of three separate batches (lots) of rLP2086 vaccine.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  11/YH/0385

• Date of REC Opinion

  12 Jan 2012

• REC opinion

  Further Information Favourable Opinion