13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants

Pediatrics
Federico Martinon-TorresAlejandra Gurtman

Abstract

This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants. 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). 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 p...Continue Reading

Citations

Mar 15, 2016·The Pediatric Infectious Disease Journal·Irene Rivero-CalleUNKNOWN MENDICOS Research Network
Mar 1, 2016·Expert Opinion on Drug Safety·Susanna Esposito, Nicola Principi
Aug 21, 2015·Human Vaccines & Immunotherapeutics·Arnaud GagneurCaroline Quach
Jul 19, 2016·Advances in Pediatrics·Laura A WangDaniel Gonzalez
Dec 3, 2016·The Pediatric Infectious Disease Journal·Federico Martinón-TorresAlejandra Gurtman
Apr 19, 2018·Pediatric Annals·Ansul Asad
Mar 26, 2019·Expert Opinion on Drug Safety·Carolina López-SanguosFederico Martinón-Torres
Oct 4, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Alison KentShamez N Ladhani
Nov 21, 2019·Indian Journal of Medical Microbiology·Rosemol VargheseS Balasubramanian
Sep 16, 2020·JAMA : the Journal of the American Medical Association·Elsbeth D M RouersGuy A M Berbers
Nov 2, 2020·Best Practice & Research. Clinical Obstetrics & Gynaecology·Tejasvi Chaudhari
Apr 1, 2019·Indian Journal of Medical Microbiology·Rosemol VargheseS Balasubramanian
Feb 19, 2021·Human Vaccines & Immunotherapeutics·Santosh SoansAshish Agrawal
Mar 10, 2020·International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases·Young June ChoeEun Hwa Choi
Jan 18, 2020·Current Pediatric Reviews·Areti Aphrodite SiorikiAgeliki Karatza

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