Safety and immunogenicity of three lots of meningococcal serogroup C conjugate vaccine administered at 2, 3 and 4 months of age

J. Claire Bramley, Timothy Hall, Adam Finn, Roger B. Buttery, David Elliman, Stephen Lockhart, Raymond Borrow, Ian G. Jones

Research output: Contribution to journalArticlepeer-review

43 Citations (Scopus)

Abstract

The reactogenicity and immunogenicity of meningococcal serogroup C conjugate (MenC) vaccine was assessed in 322 infants vaccinated at 2, 3, and 4 months of age, with concomitant administration of mixed diphtheria-tetanus-whole-cell pertussis vaccine and Haemophilus influenzae type b conjugate vaccine (DTwP-Hib) and oral polio vaccine. All infants in whom post-vaccination meningococcal C anticapsular IgG levels were assayed (n = 265) attained ≥ 2 μg ml-1. Serum bactericidal titres were assayed for a proportion of subjects (n = 171), 98% of whom obtained a reciprocal titres ≥ 8. Local reactions were less frequent at the MenC injection site than at the DTP-Hib site. Systemic events were frequent, but consistent with established DTwP-Hib experience. The study demonstrates that MenC vaccine is immunogenic and well tolerated in infants at manufacturing scale production levels.

Original languageEnglish
Pages (from-to)2924-2931
Number of pages8
JournalVaccine
Volume19
Issue number20-22
DOIs
Publication statusPublished - 6 Apr 2001
Externally publishedYes

Bibliographical note

Funding Information:
This trial was supported by a grant from Wyeth-Lederle Vaccines and Pediatrics. We gratefully acknowledge the support of the following for their invaluable help in conducting this trial. Statistical analysis was performed by Dominique Rosillon of Biopharma, Wavre, Belgium. The following contributed at the sites: Cornwall Clinical Research Group (Drs Butler, Cook, Fletcher, Gillespie, Golding-Cook, Jones, Rotheray, Thomas); Suffolk (Drs Arthur, Dunne, Kemp, Leeper and Selby); Scotland (Geraldine Allan, Elizabeth Drummond, Drs Aitken, Carlyle, Carr, Heeles, Hyndman, Krishnaswamy and Wallace, Sharon Hutchinson); Sheffield (Dr Sharon Choo, Roger Burkinshaw); London (Gail Balfour); Specialist Monitoring Services Ltd, Crowthorne, Berkshire, England (Caroline Dunn, Julie Greenfield); Manchester Public Health Laboratory (Sarah Martin, Jamie Findlow).

Keywords

  • Conjugate vaccine
  • Polysaccharide
  • Serogroup C meningococcus

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