CLINICAL TRIAL RESULTS

The ability of MenB vaccine to trigger the production of antibodies has been assessed in two main studies, as summarized by EMA. The first main study involved 2,627 children who were two months old when the study started. The effects of giving three doses of MenB vaccine at two-month intervals together with other routine infant vaccinations were compared with giving the routine vaccinations alone. This study was extended to look at the effects of giving a booster dose of the vaccine at or after 12 months of age to children who had already received it in early infancy, compared with giving two ‘catch-up’ doses to those who had not. The second main study involved 1,631 adolescents aged between 11 and 17. The effects of giving one, two or three doses of vaccine (at intervals of at least one month) were compared with giving placebo (a dummy treatment). A smaller supportive study was also carried out in adults. The studies assessed the ability of MenB vaccine to stimulate an immune response against N. meningitidis group B, by measuring the production of protective antibodies that are able to kill the bacteria showing that it was effective at stimulating an immune response to N. meningitidis group B. The study in children also showed that a single booster dose at 12 months of age produced a stronger immune response in children who had already received the vaccine than the first of two ‘catch-up’ doses in children of the same age who had not. The study in adolescents found that two doses were needed to produce an adequate immune response. Similar results were seen in adults. The most common side effects in children up to 10 years of age (seen in more than 1 patient in 10) are loss of appetite, sleepiness, unusual crying, diarrhoea, vomiting, rash, fever and irritability as well as tenderness, swelling, hardness and redness of the skin at the injection site. The most common side effects in adolescents (seen in more than 1 patient in 10) are headache, nausea (feeling sick) and malaise (feeling unwell), myalgia (muscle pain) and arthralgia (joint pain) as well as pain, swelling, hardness and redness of the skin at the injection site. The vaccine must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients.