Testing a new vaccine for babies in the UK which adds protection against hepatitis B
A new vaccine has been developed by Sanofi Pasteur MSD S.N.C. aimed at preventing 6 childhood diseases in one combination vaccine (called "6COM"). This 6COM vaccine would allow babies to be protected against a disease called hepatitis B, in addition to the five contained in the currently used vaccine, using the same number of injections. The diseases covered by the new 6COM vaccine are diphtheria, tetanus (lockjaw), pertussis (whooping cough), poliomyelitis (polio), Haemophilus influenzae type b (Hib) and hepatitis B. All babies also normally receive vaccines against meningitis. This study will assess how well children’s immune systems respond to meningitis vaccines when given with and following this new 6COM combination vaccine and will monitor the safety of all these vaccines.
The main aim of this UK study is to show whether immune responses to two widely-used meningitis vaccines (called “MenC”) are as strong as needed when given alongside the new 6COM vaccine. The study will check the antibody response in blood to the components of the 6COM and MenC vaccines given both in the first year of life and of the Hib/meningitis booster vaccine given at 12 months of age.
In addition babies in the study will be closely monitored to check for common side-effects such as fever and swelling where the vaccine is given and for any unexpected problems.