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

Vaccine. 2003 Jul 4;21(23):3265-72. doi: 10.1016/s0264-410x(03)00230-5.


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.

Publication types

  • Review

MeSH terms

  • Antibodies, Bacterial / biosynthesis
  • Clinical Trials as Topic
  • Enzyme-Linked Immunosorbent Assay
  • Humans
  • Infant
  • Infant, Newborn
  • Licensure / standards*
  • Pneumococcal Infections / immunology
  • Pneumococcal Infections / prevention & control
  • Pneumococcal Vaccines / immunology*
  • Pneumococcal Vaccines / standards*
  • United States
  • United States Food and Drug Administration
  • World Health Organization


  • Antibodies, Bacterial
  • Pneumococcal Vaccines