Trial supports safety of meningitis C vaccine
The meningococcal C vaccine introduced into the United
Kingdom primary immunisation schedule two years ago is safe for infants,
a study has shown.
Concerns over a lack of large-scale trial data had
been raised at the time of the vaccine's introduction. Dr Rahman Lakshman,
Sheffield Institute for Vaccine Studies, and colleagues conducted a trial
to look at the safety of the vaccine in 2,796 infants. The infants were
given meningococcal C vaccine at two, three and four months of age, along
with routine immunisations. Any adverse events were recorded during the
month following vaccination.
A total of 49 infants (1.8 per cent) experienced
58 adverse events that were considered possibly, probably or definitely
linked to meningococcal C vaccine. Four events were considered to be serious.
Adverse events considered to be either definitely or probably linked to
the vaccine included injection site reactions, agitation and fever. Events
possibly related included rash and gastrointestinal disturbances.
The researchers comment that some of the adverse
events are recognised to be associated with DTP (diphtheria, tetanus and
pertussis) immunisation, which was given at the same time as meningococcal
vaccine. Therefore, they conclude that the only adverse events that could
definitely be associated with the meningococcal vaccine were injection
site reactions (Archives of Disease in Childhood 2001;85:391).
Meanwhile, two studies have shown a fall in mortality
from meningococcal disease (ibid, p382 and p386). The first shows a mortality
rate among children admitted to Alder Hey Hospital, Liverpool of 8.9 per
cent, compared with a predicted value of 24.9 per cent. Heightened awareness
of the disease leading to earlier appropriate management is suggested
as a possible reason for the fall. The second study, conducted at St Mary's
Hospital, London, shows the mortality among children admitted with meningococcal
disease fell from 23 to 2 per cent between 1992 and 1997.
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