Safety and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers Given With Routine Pediatric Vaccinations in Canada

Vanderkooi, Otto G. MD*; Scheifele, David W. MD; Girgenti, Douglas MD; Halperin, Scott A. MD§; Patterson, Scott D. PhD; Gruber, William C. MD; Emini, Emilio A. PhD; Scott, Daniel A. MD; Kellner, James D. MD*; for the Canadian PCV13 Study Group

Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e318233049d
Vaccine Reports
Abstract

Background: The global distribution of pneumococcal disease and emergence of nonvaccine pneumococcal serotypes prompted the development of a 13-valent pneumococcal conjugate vaccine (PCV13), with broader coverage than 7-valent PCV (PCV7). This study compared compatibility of PCV13 and PCV7 with concurrently administered diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b vaccine, and meningococcal C conjugate vaccine (menC), and assessed the safety and immunogenicity of PCV13.

Methods: In this double-blind, randomized trial, children received PCV7 or PCV13 at 2, 4, 6, and 12 months with routine vaccinations. One month following the infant series and toddler dose, the responses to Hib, pertussis, menC, and specific pneumococcal serotypes were measured. Safety and tolerability were assessed daily for 4 days by parents.

Results: Subjects received PCV13 (n = 300) or PCV7 (n = 303); immunogenicity assessment was completed in 265 and 268 subjects, respectively. There were no statistically significant differences between the groups in responses to Hib, pertussis, or menC after primary or booster vaccinations. More than 95% of subjects in the PCV13 group produced >0.35 μg/mL antibody to each pneumococcal serotype 1 month after the third dose, except with serotypes 23F (90%), 3 (80%), and 5 (87%). After the fourth dose, 98% to 100% of subjects achieved serotype-specific antibody concentrations >0.35 μg/mL, except for serotype 3 (85%). Safety and tolerability did not differ between groups with respect to local or systemic side effects.

Conclusions: Responses to routine childhood vaccines did not differ with PCV7 or PCV13 coadministration. Serotype-specific pneumococcal antibody concentrations were protective. The safety profile of PCV13 was favorable.

Author Information

From the *Department of Pediatrics, University of Calgary & Alberta Health Services – Calgary Zone, Calgary, Alberta; †British Columbia Children's Hospital and University of British Columbia, Vancouver, British Columbia; ‡Pfizer Inc, Pearl River, New York; §Canadian Center for Vaccinology, Dalhousie University & the IWK Health Centre, Halifax, Nova Scotia; and ¶Pfizer Inc., Collegeville, Pennsylvania.

Accepted for publication July 29, 2011.

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 non-industry authors and the Canadian PCV13 study group, and conducted the data analysis and pneumococcal laboratory assays. The manuscript was prepared by the non-industry authors with review by Pfizer Inc.

O.G.V. and J.D.K. have received research support from Pfizer Inc. including Wyeth Pharmaceuticals, GlaxoSmithKline, Merck, Canada; performed contract research for Pfizer Inc./Wyeth Pharmaceuticals, GlaxoSmithKline; and were on advisory boards for GlaxoSmithKline, Novartis, Canada. D.W.S. received research support from Pfizer Inc. including Wyeth Pharmaceuticals, GlaxoSmithKline, Sanofi Pasteur, Novartis; and was on advisory boards for Novartis, GlaxoSmithKline, Sanofi Pasteur. D.G. has been employed by Pfizer Inc. S.A.H. received research support from Pfizer Inc.; and was on ad hoc advisory boards for Pfizer Inc. S.D.P. has been employed by Pfizer Inc. W.C.G. has been employed by Pfizer Inc. E.A.E. and D.A.S. have been employed by Pfizer Inc.

The authors have no other funding or conflicts of interest to disclose.

Address for correspondence: James D. Kellner, MD, Alberta Children's Hospital, 2888 Shaganappi Trail, NW, Calgary, Alberta T3B 6A8. E-mail: Jim.Kellner@albertahealthservices.ca.

© 2012 Lippincott Williams & Wilkins, Inc.