Article
Safety of a new conjugate meningococcal C vaccine in infants
R Lakshmana, I Jonesb, D Walkerb, K McMurtriea, L Shawa, G Racea, S Chooa, L Danzigc, P Osterc, A Finna
a Sheffield Institute
for Vaccine Studies, Sheffield Children's Hospital, Sheffield S10
2TH, UK, b Scottish
Centre for Infection and Environmental Health, Clifton House, Clifton
Place, Glasgow G3 7LN, UK, c Chiron SpA, via Fiorentina 1, 53100, Siena,
Italy
Correspondence to: Dr Lakshman R.Lakshman{at}sheffield.ac.uk
Accepted 11 July 2001
BACKGROUND
Group C conjugate
meningococcal vaccines (Men C) were introduced into the UK primary
immunisation schedule in November 1999. There has been extensive
professional and public interest in their efficacy and safety.
AIMTo determine the occurrence of
at least one uncommon adverse event in infants related to the
administration of the Chiron Men C vaccine.
METHODSA total of 2796 infants
aged approximately 2 months were recruited into the study from areas in
and around Sheffield and from Scotland. They were vaccinated with the
Chiron Men C vaccine at 2, 3, and 4 months along with routine
immunisations. Data on adverse events occurring one month after each
dose were collected actively and prospectively and reviewed for
possible relation to the vaccine.
RESULTSThere were no deaths. There
were no serious adverse events considered definitely or probably caused
by the vaccine. Four infants developed serious adverse events
(hypotonia, screaming syndrome, maculopapular rash, and agitation,
respectively) that were considered possibly related to the vaccine. All
recovered completely. Adverse events were seen in 1804 children but
were considered possibly related to the vaccine in only 49 (1.8%). On
subsequent immunisation there were no recurrences of adverse events
considered to be possibly related to the vaccine.
Keywords: vaccine; meningococcal; Men C; meningitis; immunisation; adverse reaction
© 2001 by Archives of Disease in Childhood
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