The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY).

Human Vaccines & Immunotherapeutics
Stephen RinderknechtJacqueline M Miller

Abstract

The safety profile of HibMenCY was compared with licensed Hib conjugate vaccines in a pooled analysis that included more than 8,500 subjects who were administered a four-dose series of HibMenCY or commercially available Hib vaccines at 2, 4, 6 and 12-15 mo of age in two primary vaccination and two fourth dose phase 3 studies. In all studies, HibMenCY or Hib vaccine was co-administered with age-appropriate, routinely recommended vaccines. In one primary and one fourth dose study (n = 4180), local and general symptoms were solicited using diary cards for 4 d after each dose. Serious adverse events (SAEs) and the occurrence of adverse events (AEs) indicating new onset of chronic disease (NOCD), rash, and conditions prompting Emergency Room (ER) visits were reported from dose 1 until 6 mo after dose 4. The incidences of solicited local and general symptoms were similar following HibMenCY and commercially available Hib vaccines. For some solicited symptoms (pain at the injection site and irritability), rates were lower in the HibMenCY group compared with the Hib control group (p value < 0.05). There were no statistically significant differences between groups in the incidences of SAEs, NOCDs, rash, or AEs leading to ER visits, with ...Continue Reading

References

Dec 17, 2009·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Amanda C CohnNancy E Messonnier

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Citations

Jun 1, 2013·Infectious Diseases and Therapy·Kirsten P PerrettJodie McVernon
Dec 20, 2013·The Annals of Pharmacotherapy·Sarah F HaleBen M Lomaestro

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Methods Mentioned

BETA
blood draw

Clinical Trials Mentioned

NCT00289783
NCT00345579
NCT00345683

Software Mentioned

SAS®

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