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Immunogenicity and Reactogenicity of a 13-Valent-pneumococcal Conjugate Vaccine Administered at 2, 4, and 12 Months of Age: A Double-blind Randomized Active-controlled Trial

Snape, Matthew D. MB BS, MD*; Klinger, Chaam L. MB BS*; Daniels, Elvis D. MD, PhD†; John, Tessa M. RN*; Layton, Helen BA*; Rollinson, Llinos RN*; Pestridge, Sarah BSc‡; Dymond, Sandra RN§; Galiza, Eva BSc, MB BS¶; Tansey, Susan MB ChB†; Scott, Daniel A. MD†; Baker, Sherryl A. PhD†; Jones, Thomas R. PhD†; Yu, Ly-Mee MSc∥; Gruber, William C. PhD†; Emini, Emilio A. PhD†; Faust, Saul N. PhD‡; Finn, Adam PhD§; Heath, Paul T. FRACP, FRCPCH¶; Pollard, Andrew J. MB BS, PhD*

Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e3181faa6be
Original Studies
Abstract

Background: A 2-, 4-, and 12-month schedule of a novel 13-valent-pneumococcal conjugate vaccine (PCV13), containing serotype 1, 3, 4, 5, 6A, 6B 7F, 9V, 14, 18C, 19A, 19F, and 23F polysaccharides individually conjugated to CRM197 was evaluated in a randomized, double-blind, controlled infant study.

Methods: Two hundred eighty-six healthy infants received PCV13 or the 7-valent-pneumococcal conjugate vaccine (PCV7) at 2, 4, and 12 months of age, alongside a serogroup C meningococcal (MenC) vaccine (2 and 4 months of age), DTaP-IPV-Hib (2, 3, and 4 months), and a Hib-MenC vaccine (12 months). Specific antibody responses were assessed at age 5, 12, and 13 months.

Results: At 13 months of age, >97% of PCV13 recipients had pneumococcal serotype-specific serum IgG concentrations ≥0.35 μg/mL for each vaccine serotype except serotype 3 (88.2%), and at least 93% of PCV13 recipients had OPA titers ≥1:8 for each serotype. At 5 months, 110/114 (96.5%) of PCV13 recipients and 100/102 (98.0%) of PCV7 recipients had serum anti-PRP (Hib) IgG concentration ≥0.15 μg/mL (difference, 1.5%; CI, −7.1%–3.7%), while 119/120 (99.2%) and 117/118 (99.2%), respectively, had MenC serum bactericidal assay titers of ≥1:8. All PCV13 recipients and 110/113 (97.3%) of PCV7 recipients had IgG concentrations against fimbrial agglutinogens of ≥2.2 EU/mL; IgG concentrations for the remaining pertussis antigens were ≥5 EU/mL for all participants. Local reactions and systemic events were similar in the PCV13 and PCV7 groups.

Conclusions: A 2-, 4-, and 12-month course of PCV13 was immunogenic for all 13 vaccine serotypes and was well tolerated.

Author Information

From the *Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Headington, United Kingdom; †Pfizer Inc, Pearl River, NY; ‡Wellcome Trust Clinical Research Facility, Southampton University Hospitals NHS Trust, University of Southampton, Southampton, United Kingdom; §Bristol Children's Vaccine Centre, University Hospitals Bristol NHS Foundation Trust, University of Bristol, Bristol, United Kingdom; ¶St George's Vaccine Institute, University of London, London, United Kingdom; and ∥Centre for Statistics in Medicine, Wolfson College Annexe, Oxford, United Kingdom.

Accepted for publication August 4, 2010.

Supported by Wyeth Pharmaceuticals, Collegeville, PA (acquired by Pfizer Inc in October 2009) who/which also acted as study sponsor, prepared the study design and statistical analysis plan in collaboration with the Oxford Vaccine Group and conducted the pneumococcal laboratory assays. The Oxford Vaccine Group receives funding from the NIHR Oxford Partnership Comprehensive Biomedical Research Centre program (including salary support for T.M.J. and M.D.S.) and the Thames Valley Comprehensive Clinical Research network. This study was adopted by the NIHR Medicines for Children Research Network and supported by their South West Local Research Network.

Ethical approval was obtained from Oxfordshire Research Ethics Committee (Reference Number 06/Q1604/67) and the local Research Ethics Committees of the different study sites.

Clinicaltrials.gov registration number: NCT00384059.

Address for correspondence: Matthew D. Snape, MBBS, MD, c/o Oxford Vaccine Group, CCVTM, Churchill Hospital, Old Road, Headington, Oxford, United Kingdom OX3 7LJ. E-mail: matthew.snape@paediatrics.ox.ac.uk.

© 2010 by Lippincott Williams & Wilkins, Inc.