Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants

Luis Jódar, Jay Butler, George Carlone, Ron Dagan, David Goldblatt, Helena Käyhty, Keith Klugman, Brian Plikaytis, George Siber, Robert Kohberger, Ih Chang, Thomas Cherian

Research output: Contribution to journalArticlepeer-review

Abstract

The World Health Organization (WHO) is undertaking a series of consultations on serological criteria for the evaluation and licensure of new formulations/combinations or different vaccination schedules of pneumococcal conjugate vaccines. The lack of a definitive serological correlate of protection and the multiplicity of antigens involved, especially since the clinical efficacy of most of the individual serotypes represented in the only licensed vaccine has not been established, are hindering the formulation of criteria for licensure of new formulations or combinations of the vaccine. This report analyses the various options with their relative merits and drawbacks and provides preliminary recommendations as guidance to regulatory agencies in evaluating these vaccines for the purposes of licensure. More detailed recommendations for production and control of pneumococcal conjugate vaccines, including criteria for evaluation for licensure, are currently being drafted.

Original languageEnglish (US)
Pages (from-to)3265-3272
Number of pages8
JournalVaccine
Volume21
Issue number23
DOIs
StatePublished - Jul 4 2003
Externally publishedYes

Keywords

  • Conjugate vaccine
  • Correlates of protection
  • Streptococcus pneumoniae

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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