Background: A 13-valent pneumococcal conjugate vaccine (PCV13) has been licensed in >100 countries to broaden coverage against pneumococcal disease. We assessed whether PCV13 interferes with immune responses to concomitantly administered routine pediatric vaccines.
Methods: Healthy US infants were randomly assigned in 2 studies to receive PCV13 or 7-valent PCV (PCV7) at age 2, 4 and 6 months concomitantly with diphtheria, tetanus, acellular pertussis, inactivated polio virus, hepatitis B and Haemophilus influenzae type b, and at age 12–15 months with measles, mumps, rubella, varicella and hepatitus A. Antibodies to pertussis antigens, diphtheria, tetanus toxoid, poliovirus types 1–3, Haemophilus influenzae type b polyribosylribitol phosphate capsular polysaccharide and polyribosylribitol phosphate capsular polysaccharide were measured 1 month after the infant series; measles, mumps, rubella, varicella and polyribosylribitol phosphate capsular polysaccharide were determined 1 month after the toddler dose. Both the percentages of responders (subjects reaching a prespecified antibody concentration) and immunoglobulin G antibody geometric mean concentrations/titers were calculated for each concomitant vaccine antigen.
Results: Not all assays were performed on all subjects. Data were available from 153 to 239 infants and 163–230 toddlers in the PCV13 group and 173–240 infants and 167–214 toddlers in the PCV7 group. One month after both infant series and the toddler dose, noninferiority criteria were met for all antigens with respect to percentage of responders in both PCV7 and PCV13 groups. Immunoglobulin G antibody geometric mean concentration/titer ratios (PCV13/PCV7) were 0.91–1.33 and 0.83–1.03 at 1 month after the infant series and toddler dose, respectively, and met predetermined noninferiority criteria.
Conclusions: Immune responses to routine pediatric vaccines concomitantly administered with PCV13 were noninferior to responses achieved when administered with PCV7.
From the *University of Louisville, Louisville, KY; †Pfizer Inc, Pearl River, NY; ‡Primary Physicians Research, Pittsburgh, PA; §Arkansas Pediatrics, Little Rock, AR; and ¶Pfizer Inc, Collegeville, PA.
Accepted for publication October 17, 2012.
The trial registration numbers were ClinicalTrials.gov NCT00373958 and NCT00444457.
These studies were sponsored by Wyeth, which was acquired by Pfizer Inc in October 2009. K.A.B. received grant funding paid to her institution for the conduct of both the 004 and 3005 studies and travel funding to present research findings from Pfizer Inc. K.A.B. also reports that she has received honoraria as a speaker for Sanofi Pasteur, and as an advisory board member for GlaxoSmithKline. A.G., D.G., M.W.P., S.P., C.D., W.C.G., E.A.E. and D.A.S. are employees of Pfizer Inc. Medical writing support was provided by Naomi Pliskow, MD, at Pfizer Inc and funded by Pfizer Inc. Editorial support was provided by Elaine Santiago, PharmD, at Excerpta Medica and was funded by Pfizer Inc. The authors have no other funding or conflicts of interest to disclose.
Address for correspondence: Kristina A. Bryant, MD, Associate Professor of Pediatrics, University of Louisville School of Medicine, 571 S. Floyd Street, Louisville, KY 40202. E-mail: firstname.lastname@example.org.