title: 13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants.
abstract: OBJECTIVE
  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.
authors.affiliation: Translational 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; federico.martinon.torres@sergas.es.
authors.forename: Federico
authors.initials: F
authors.lastname: Martinón-Torres
authors.affiliation: Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika-Regional Infectious Diseases Outpatient Clinic, Krakow, Poland;
authors.forename: Hanna
authors.initials: H
authors.lastname: Czajka
authors.affiliation: Pfizer Inc, Collegeville, Pennsylvania;
authors.forename: Kimberly J
authors.initials: KJ
authors.lastname: Center
authors.affiliation: Poznań University of Medical Sciences, Poznań, Poland;
authors.forename: Jacek
authors.initials: J
authors.lastname: Wysocki
authors.affiliation: Medical University of Lodz, Lodz, Poland;
authors.forename: Ewa
authors.initials: E
authors.lastname: Majda-Stanislawska
authors.affiliation: Hospital Infantil La Paz, Madrid, Spain;
authors.forename: Felix
authors.initials: F
authors.lastname: Omeñaca
authors.affiliation: Servicio de Pediatría y Unidad de Investigación en Vacunas Fundación Miguel Servet Complejo Hospitalario de Navarra, Pamplona, Spain;
authors.forename: Enrique
authors.initials: E
authors.lastname: Bernaola Iturbe
authors.affiliation: Pediatric Infectious Diseases and Immunodeficiencies Unit, Hospital Universitario 12 de Octubre, Madrid, Spain;
authors.forename: Daniel
authors.initials: D
authors.lastname: Blazquez Gamero
authors.affiliation: Complexo Hospitalario Universitario de Vigo, Vigo, Spain;
authors.forename: Ana
authors.initials: A
authors.lastname: Concheiro-Guisán
authors.affiliation: Hospital Torrecardenas, Almeria, Spain;
authors.forename: Francisco
authors.initials: F
authors.lastname: Gimenez-Sanchez
authors.affiliation: Department of Pediatric Infectious Diseases, Medical University, Wroclaw, Poland; and.
authors.forename: Leszek
authors.initials: L
authors.lastname: Szenborn
authors.affiliation: Pfizer Inc, Pearl River, New York.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Giardina
authors.affiliation: Pfizer Inc, Collegeville, Pennsylvania;
authors.forename: Scott
authors.initials: S
authors.lastname: Patterson
authors.affiliation: Pfizer Inc, Pearl River, New York.
authors.forename: William C
authors.initials: WC
authors.lastname: Gruber
authors.affiliation: Pfizer Inc, Pearl River, New York.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Scott
authors.affiliation: Pfizer Inc, Pearl River, New York.
authors.forename: Alejandra
authors.initials: A
authors.lastname: Gurtman
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D000917:Antibody Formation / Q000276:immunology; D000918:Antibody Specificity / Q000276:immunology; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood*; D007223:Infant; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000276:immunology* / Q000517:prevention & control*; D007273:Injections, Intramuscular; D008297:Male; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D011044:Poland; D013030:Spain; D013296:Streptococcus pneumoniae / Q000276:immunology*
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D022242:Pneumococcal Vaccines
keywords: immunization; immunogenicity; pneumococcal conjugate vaccine; preterm infants; safety