Pediatrics
April 2015, VOLUME 135 / ISSUE 4
http://pediatrics.aappublications.org/current.shtml

Article
13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Preterm Versus Term Infants
Federico Martinón-Torres, MD, PhDa, Hanna Czajka, MDb, Kimberly J. Center, MDc, Jacek Wysocki, MDd, Ewa Majda-Stanislawska, MDe, Felix Omeñaca, MDf, Enrique Bernaola Iturbe, MDg, Daniel Blazquez Gamero, MDh, Ana Concheiro-Guisán, MD, PhDi, Francisco Gimenez-Sanchez, MD, PhDj, Leszek Szenborn, MDk, Peter C. Giardina, PhDl, Scott Patterson, PhDc,
William C. Gruber, MDl, Daniel A. Scott, MDl, and Alejandra Gurtman, MDl
Author Affiliations
aTranslational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela and Vaccine Research Unit, Genetics, Vaccines, Infections and Pediatrics Research Group (GENVIP), Healthcare Research Institute of Santiago, Santiago de Compostela, Spain;
bWojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika–Regional Infectious Diseases Outpatient Clinic, Krakow, Poland;
cPfizer Inc, Collegeville, Pennsylvania;
dPoznań University of Medical Sciences, Poznań, Poland;
eMedical University of Lodz, Lodz, Poland;
fHospital Infantil La Paz, Madrid, Spain;
gServicio de Pediatría y Unidad de Investigación en Vacunas Fundación Miguel Servet Complejo Hospitalario de Navarra, Pamplona, Spain;
hPediatric Infectious Diseases and Immunodeficiencies Unit, Hospital Universitario 12 de Octubre, Madrid, Spain;
iComplexo Hospitalario Universitario de Vigo, Vigo, Spain;
jHospital Torrecardenas, Almeria, Spain;
kDepartment of Pediatric Infectious Diseases, Medical University, Wroclaw, Poland; and
lPfizer Inc, Pearl River, New York
Abstract
OBJECTIVES: This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants.
METHODS: This Phase IV, open-label, 2-arm, multicenter, parallel-group study enrolled 200 healthy infants (preterm, n = 100; term, n = 100) aged 42 to 98 days. All subjects received PCV13 at ages 2, 3, 4 (infant series), and 12 (toddler dose [TD]) months, together with routine vaccines (diphtheria-tetanus-acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine and meningococcal group C conjugate vaccine).
RESULTS: Most subjects achieved an anticapsular immunoglobulin G (IgG) antibody concentration ≥0.35 μg/mL for all serotypes: >85% after the infant series (except preterm infants for serotypes 5, 6A, and 6B) and >97% after TD (except for serotype 3). Preterm infants had overall lower IgG geometric mean concentrations compared with term infants; however, geometric mean fold increases after TD were similar for all serotypes. Opsonophagocytic activity results were consistent with IgG results and titers increased after TD in both groups for all serotypes, including serotype 3. PCV13 was generally well tolerated, with similar safety profiles in all preterm subgroups.
CONCLUSIONS: Immune responses were lower in preterm infants than in term infants. However, the majority of subjects in both groups achieved both pneumococcal serotype-specific IgG antibody levels after the infant series that exceeded the World Health Organization–established threshold of protection and functional antibody responses. Responses were uniformly higher after TD, reinforcing the importance of a timely booster dose. PCV13 was well tolerated regardless of gestational age.