{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T15:12:58Z","timestamp":1791385978238,"version":"4.3.3"},"reference-count":28,"publisher":"American Academy of Pediatrics (AAP)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2015,4,1]]},"abstract":"<jats:sec>\n                  <jats:title>OBJECTIVES:<\/jats:title>\n                  <jats:p>This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>METHODS:<\/jats:title>\n                  <jats:p>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).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS:<\/jats:title>\n                  <jats:p>Most subjects achieved an anticapsular immunoglobulin G (IgG) antibody concentration \u22650.35 \u03bcg\/mL for all serotypes: &amp;gt;85% after the infant series (except preterm infants for serotypes 5, 6A, and 6B) and &amp;gt;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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS:<\/jats:title>\n                  <jats:p>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\u2013established 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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1542\/peds.2014-2941","type":"journal-article","created":{"date-parts":[[2015,3,17]],"date-time":"2015-03-17T00:48:40Z","timestamp":1426553320000},"page":"e876-e886","source":"Crossref","is-referenced-by-count":46,"title":["13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Preterm Versus Term Infants"],"prefix":"10.1542","volume":"135","author":[{"given":"Federico","family":"Martin\u00f3n-Torres","sequence":"first","affiliation":[{"name":"Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Cl\u00ednico 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;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanna","family":"Czajka","sequence":"additional","affiliation":[{"name":"Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika\u2013Regional Infectious Diseases Outpatient Clinic, Krakow, Poland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly J.","family":"Center","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Collegeville, Pennsylvania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacek","family":"Wysocki","sequence":"additional","affiliation":[{"name":"Pozna\u0144 University of Medical Sciences, Pozna\u0144, Poland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ewa","family":"Majda-Stanislawska","sequence":"additional","affiliation":[{"name":"Medical University of Lodz, Lodz, Poland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felix","family":"Ome\u00f1aca","sequence":"additional","affiliation":[{"name":"Hospital Infantil La Paz, Madrid, Spain;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrique","family":"Bernaola Iturbe","sequence":"additional","affiliation":[{"name":"Servicio de Pediatr\u00eda y Unidad de Investigaci\u00f3n en Vacunas Fundaci\u00f3n Miguel Servet Complejo Hospitalario de Navarra, Pamplona, Spain;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Blazquez Gamero","sequence":"additional","affiliation":[{"name":"Pediatric Infectious Diseases and Immunodeficiencies Unit, Hospital Universitario 12 de Octubre, Madrid, Spain;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Concheiro-Guis\u00e1n","sequence":"additional","affiliation":[{"name":"Complexo Hospitalario Universitario de Vigo, Vigo, Spain;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco","family":"Gimenez-Sanchez","sequence":"additional","affiliation":[{"name":"Hospital Torrecardenas, Almeria, Spain;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leszek","family":"Szenborn","sequence":"additional","affiliation":[{"name":"Department of Pediatric Infectious Diseases, Medical University, Wroclaw, Poland; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter C.","family":"Giardina","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Pearl River, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Patterson","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Collegeville, Pennsylvania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William C.","family":"Gruber","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Pearl River, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel A.","family":"Scott","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Pearl River, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alejandra","family":"Gurtman","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Pearl River, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2015,4,1]]},"reference":[{"issue":"1","key":"2021120907064116900_B1","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1086\/313609","article-title":"The contribution of specific pneumococcal serogroups to different disease manifestations: implications for conjugate vaccine formulation and use, part II.","volume":"30","author":"Hausdorff","year":"2000","journal-title":"Clin Infect Dis"},{"issue":"3","key":"2021120907064116900_B2","doi-asserted-by":"crossref","first-page":"182","DOI":"10.1097\/00006454-200203000-00003","article-title":"Efficacy, immunogenicity and safety of heptavalent pneumococcal conjugate vaccine in low birth weight and preterm infants.","volume":"21","author":"Shinefield","year":"2002","journal-title":"Pediatr Infect Dis J"},{"issue":"5-6","key":"2021120907064116900_B3","doi-asserted-by":"crossref","first-page":"647","DOI":"10.1016\/S0264-410X(01)00418-2","article-title":"Materno-foetal transfer of H. influenzae and pneumococcal antibodies is influenced by prematurity and low birth weight: implications for conjugate vaccine trials.","volume":"20","author":"Okoko","year":"2001","journal-title":"Vaccine"},{"issue":"9","key":"2021120907064116900_B4","doi-asserted-by":"crossref","first-page":"824","DOI":"10.1097\/INF.0b013e318124a9c8","article-title":"Antibody persistence and booster vaccination during the second and fifth years of life in a cohort of children who were born prematurely.","volume":"26","author":"Ome\u00f1aca","year":"2007","journal-title":"Pediatr Infect Dis J"},{"issue":"14","key":"2021120907064116900_B5","doi-asserted-by":"crossref","first-page":"1703","DOI":"10.1016\/j.vaccine.2004.09.029","article-title":"Immunogenicity, safety and tolerability of heptavalent pneumococcal conjugate vaccine administered at 3, 5 and 11 months post-natally to pre- and full-term infants.","volume":"23","author":"Esposito","year":"2005","journal-title":"Vaccine"},{"issue":"11","key":"2021120907064116900_B6","doi-asserted-by":"crossref","first-page":"1810","DOI":"10.1128\/CVI.00214-10","article-title":"Responses to a conjugate pneumococcal vaccine in preterm infants immunized at 2, 3, and 4 months of age.","volume":"17","author":"Moss","year":"2010","journal-title":"Clin Vaccine Immunol"},{"issue":"2","key":"2021120907064116900_B7","doi-asserted-by":"crossref","first-page":"264","DOI":"10.1016\/j.vaccine.2006.07.036","article-title":"Immunogenicity and induction of immunological memory of the heptavalent pneumococcal conjugate vaccine in preterm UK infants.","volume":"25","author":"Ruggeberg","year":"2007","journal-title":"Vaccine"},{"key":"2021120907064116900_B8","unstructured":"Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. Available at: ftp:\/\/ftp.cordis.europa.eu\/pub\/fp7\/docs\/ethical-considerations-paediatrics_en.pdf. Accessed April 2, 2014"},{"issue":"4","key":"2021120907064116900_B9","first-page":"514","article-title":"Enzyme-linked immunosorbent assay for quantitation of human antibodies to pneumococcal polysaccharides.","volume":"10","author":"Wernette","year":"2003","journal-title":"Clin Diagn Lab Immunol"},{"issue":"41","key":"2021120907064116900_B10","doi-asserted-by":"crossref","first-page":"7207","DOI":"10.1016\/j.vaccine.2011.06.056","article-title":"The 13-valent pneumococcal conjugate vaccine (PCV13) elicits cross-functional opsonophagocytic killing responses in humans to Streptococcus pneumoniae serotypes 6C and 7A.","volume":"29","author":"Cooper","year":"2011","journal-title":"Vaccine"},{"key":"2021120907064116900_B11","unstructured":"World Health Organization. Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines. WHO Technical Report Series 2009; Annex 2: No. 927. Available at: www.who.int\/biologicals\/areas\/vaccines\/pneumo\/Pneumo_final_23APRIL_2010.pdf. Accessed August 4, 2014"},{"issue":"19","key":"2021120907064116900_B12","doi-asserted-by":"crossref","first-page":"3816","DOI":"10.1016\/j.vaccine.2007.01.119","article-title":"Estimating the protective concentration of anti-pneumococcal capsular polysaccharide antibodies.","volume":"25","author":"Siber","year":"2007","journal-title":"Vaccine"},{"issue":"4","key":"2021120907064116900_B13","doi-asserted-by":"crossref","first-page":"392","DOI":"10.1097\/INF.0b013e31824b972b","article-title":"13-Valent pneumococcal conjugate vaccine given with meningococcal C-tetanus toxoid conjugate and other routine pediatric vaccinations: immunogenicity and safety.","volume":"31","author":"Martin\u00f3n-Torres","year":"2012","journal-title":"Pediatr Infect Dis J"},{"issue":"4","key":"2021120907064116900_B14","doi-asserted-by":"crossref","first-page":"1202","DOI":"10.1111\/j.0006-341X.1999.01202.x","article-title":"Test-based exact confidence intervals for the difference of two binomial proportions.","volume":"55","author":"Chan","year":"1999","journal-title":"Biometrics"},{"key":"2021120907064116900_B15","doi-asserted-by":"crossref","first-page":"79","DOI":"10.3389\/fnins.2013.00079","article-title":"The immune consequences of preterm birth.","volume":"7","author":"Melville","year":"2013","journal-title":"Front Neurosci"},{"issue":"4","key":"2021120907064116900_B16","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2005-0348","article-title":"Haemophilus influenzae type b immunization in infants in the United Kingdom: effects of diphtheria\/tetanus\/acellular pertussis\/Hib combination vaccine, significant prematurity, and a fourth dose.","volume":"117","author":"Berrington","year":"2006","journal-title":"Pediatrics"},{"issue":"11","key":"2021120907064116900_B17","doi-asserted-by":"crossref","first-page":"966","DOI":"10.1097\/01.inf.0000187027.45918.6a","article-title":"Immunogenicity and immunologic memory of meningococcal C conjugate vaccine in premature infants.","volume":"24","author":"Collins","year":"2005","journal-title":"Pediatr Infect Dis J"},{"issue":"5","key":"2021120907064116900_B18","doi-asserted-by":"crossref","first-page":"633","DOI":"10.1093\/cid\/cis934","article-title":"Impact of the 7-valent pneumococcal conjugate vaccine on invasive pneumococcal disease in infants younger than 90 days in England and Wales.","volume":"56","author":"Ladhani","year":"2013","journal-title":"Clin Infect Dis"},{"issue":"25","key":"2021120907064116900_B19","doi-asserted-by":"crossref","first-page":"4192","DOI":"10.1016\/j.vaccine.2010.04.008","article-title":"Safety, tolerability, and immunologic noninferiority of a 13-valent pneumococcal conjugate vaccine compared to a 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany.","volume":"28","author":"Kieninger","year":"2010","journal-title":"Vaccine"},{"issue":"3","key":"2021120907064116900_B20","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2009-3027","article-title":"Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers.","volume":"126","author":"Yeh","year":"2010","journal-title":"Pediatrics"},{"issue":"52","key":"2021120907064116900_B21","doi-asserted-by":"crossref","first-page":"6232","DOI":"10.1016\/j.vaccine.2013.10.032","article-title":"Prompt effect of replacing the 7-valent pneumococcal conjugate vaccine with the 13-valent vaccine on the epidemiology of invasive pneumococcal disease in Norway.","volume":"31","author":"Steens","year":"2013","journal-title":"Vaccine"},{"issue":"49","key":"2021120907064116900_B22","doi-asserted-by":"crossref","first-page":"9127","DOI":"10.1016\/j.vaccine.2011.09.112","article-title":"Effectiveness of the new serotypes in the 13-valent pneumococcal conjugate vaccine.","volume":"29","author":"Miller","year":"2011","journal-title":"Vaccine"},{"key":"2021120907064116900_B23","doi-asserted-by":"crossref","first-page":"12","DOI":"10.1186\/1471-2334-10-12","article-title":"Effect of heptavalent pneumococcal conjugate vaccination on invasive pneumococcal disease in preterm born infants.","volume":"10","author":"R\u00fcckinger","year":"2010","journal-title":"BMC Infect Dis"},{"key":"2021120907064116900_B24","doi-asserted-by":"crossref","first-page":"S81","DOI":"10.1097\/MPG.0b013e31816e219e","article-title":"European Society for Paediatric Gastroenterology, Hepatology, and Nutrition\/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe.","volume":"46","author":"Guarino","year":"2008","journal-title":"J Pediatr Gastroenterol Nutr"},{"key":"2021120907064116900_B25","doi-asserted-by":"crossref","first-page":"62","DOI":"10.1186\/1471-2334-12-62","article-title":"Burden of community-acquired and nosocomial rotavirus gastroenteritis in the pediatric population of Western Europe: a scoping review.","volume":"12","author":"Ogilvie","year":"2012","journal-title":"BMC Infect Dis"},{"issue":"2","key":"2021120907064116900_B26","doi-asserted-by":"crossref","first-page":"93","DOI":"10.17795\/compreped-10273","article-title":"Epidemiology of lower respiratory tract infections in children.","volume":"4","author":"Boloursaz","year":"2013","journal-title":"J Compr Pediatr."},{"key":"2021120907064116900_B27"},{"issue":"6","key":"2021120907064116900_B28","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2009-2992","article-title":"Immunogenicity and safety of H influenzae type b-N meningitidis C\/Y conjugate vaccine in infants.","volume":"127","author":"Bryant","year":"2011","journal-title":"Pediatrics"}],"container-title":["Pediatrics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/135\/4\/e876\/1060584\/peds_2014-2941.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/135\/4\/e876\/1060584\/peds_2014-2941.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,10]],"date-time":"2021-12-10T01:31:15Z","timestamp":1639099875000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.aap.org\/pediatrics\/article\/135\/4\/e876\/33568\/13-Valent-Pneumococcal-Conjugate-Vaccine-PCV13-in"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,4,1]]},"references-count":28,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2015,4,1]]},"published-print":{"date-parts":[[2015,4,1]]}},"URL":"https:\/\/doi.org\/10.1542\/peds.2014-2941","relation":{},"ISSN":["0031-4005","1098-4275"],"issn-type":[{"value":"0031-4005","type":"print"},{"value":"1098-4275","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,4,1]]}}}