Safety of a new conjugate meningococcal C vaccine in infants. Issue 5 (1st November 2001)

• Record Type: Journal Article
• Authors: Lakshman, R; Jones, I; Walker, D; McMurtrie, K; Shaw, L; Race, G; Choo, S; Danzig, L; Oster, P; Finn, A
• Is Part Of: Archives of disease in childhood. Volume 85:Issue 5(2001)
• Page Start: 391
• Page End: 397
• Publication Date: 2001-11-01
• Subjects: vaccine -- meningococcal -- Men C -- meningitis -- immunisation -- adverse reaction; Children -- Diseases -- Periodicals; Infants -- Diseases -- Periodicals; 618.920005
• DOI: 10.1136/adc.85.5.391
• Languages: English
• ISSNs: 0003-9888

Abstract

Abstract : 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. AIM: To determine the occurrence of at least one uncommon adverse event in infants related to the administration of the Chiron Men C vaccine. METHODS: A 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. RESULTS: There 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.