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Randomised, controlled trial of concomitant pneumococcal and meningococcal conjugate vaccines.

Abstract
A randomised, open-label study compared the immunogenicity and safety of 7-valent pneumococcal conjugate vaccine (PCV7) and meningococcal C conjugate vaccine (MnCC vaccine) administered concomitantly and individually. Infants received PCV7+MnCC vaccine (n=265), PCV7 alone (n=268) or MnCC vaccine alone (n=178). PCV7 was administered at 2, 3½, 6 and 12 months, and MnCC vaccine at 2, 6 and 12 months. For the 7 pneumococcal serotypes tested (4, 6B, 9V, 14, 18C, 19F and 23F), proportions of subjects with pneumococcal serotype-specific immunoglobulin G (IgG) antibody concentrations ≥0.35 μg/mL post-infant series were non-inferior for the PCV7+MnCC vaccine (91.5-99.6%) and PCV7 (89.0-99.6%) groups. Proportions of subjects achieving serogroup C meningococcal serum bactericidal assay titres ≥1:8 post-infant series were non-inferior for the PCV7+MnCC vaccine (99.6%) and MnCC vaccine groups (98.8%). Pneumococcal IgG antibody levels were similar in the PCV7+MnCC vaccine and PCV7 groups at each time point. Post-infant and post-toddler meningococcus C serum bactericidal assay titres and IgG levels were similar in the PCV7+MnCC vaccine and MnCC groups, although pre-toddler, the levels were lower in the PCV7+MnCC vaccine group than the MnCC vaccine group. Immune response rates to diphtheria antigen approached 100% for all vaccine groups. Local reactions were mostly similar among the treatment groups. The MnCC vaccine group had lower rates of some systemic events than the PCV7+MnCC vaccine group. Immune responses to PCV7+MnCC vaccine were non-inferior compared with those seen with each vaccine administered alone.
AuthorsJ Wysocki, S Tansey, E Brachet, S Baker, W Gruber, P Giardina, A Arora
JournalVaccine (Vaccine) Vol. 28 Issue 49 Pg. 7779-86 (Nov 16 2010) ISSN: 1873-2518 [Electronic] Netherlands
PMID20883736 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
CopyrightCopyright © 2010 Elsevier Ltd. All rights reserved.
Chemical References
  • Antibodies, Bacterial
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Immunoglobulin G
  • Meningococcal Vaccines
  • Pneumococcal Vaccines
  • Vaccines, Conjugate
  • serogroup C meningococcal conjugate vaccine
Topics
  • Antibodies, Bacterial (blood)
  • Female
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Humans
  • Immunoglobulin G (blood)
  • Infant
  • Male
  • Meningococcal Infections (immunology, prevention & control)
  • Meningococcal Vaccines (administration & dosage, adverse effects, immunology)
  • Pneumococcal Infections (immunology, prevention & control)
  • Pneumococcal Vaccines (administration & dosage, adverse effects, immunology)
  • Serum Bactericidal Antibody Assay
  • Vaccines, Conjugate (administration & dosage, adverse effects, immunology)

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