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

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*

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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.

© 2010 by Lippincott Williams & Wilkins, Inc.


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