Investigators: Beth Arrowsmith, Camille Gibson, Christina Anthony, Fiona McDonald, Jan Jones, Jane Jones, Jennifer Kent, Krist Ewe, Lisa Montgomery, Nikki Schultz, Peter Richmond, Tanya Stoney
Project description
The purpose of this study is to investigate a new vaccine against Meningococcal B disease when administered to healthy toddlers aged 12-24 months. The trial will describe the immune response and evaluate the safety profile by comparing two different dose strength (60mcg & 120mcg) of the vaccine.
A vaccine against meningococcal B is not currently available on the Australian Immunisation Schedule but it is available privately (Bexsero).
Participants are randomly assigned in a 2:1 ratio to receive either the study vaccine or the control (HAV- Hepatitis A vaccine). Vaccine or control is administered in a 3 dose schedule at 0, 2 and 6 months.
During 2016 global study recruitment was successfully completed. At this site we randomised and vaccinated 30 participants. Almost all participants have now received their final study vaccine (dose 3) and continue to actively engage in the study visits.
Partners
- Pfizer