PMID- 32586764 OWN - NLM STAT- MEDLINE DCOM- 20210427 LR - 20210427 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 38 IP - 33 DP - 2020 Jul 14 TI - Post-marketing surveillance study of the DTaP2-IPV-HB-Hib (Hexyon) vaccine administered in preterm infants in the Apulia region, Italy, in 2017. PG - 5148-5153 LID - S0264-410X(20)30806-9 [pii] LID - 10.1016/j.vaccine.2020.06.033 [doi] AB - Recommendations in many countries state that preterm infants (PTIs) should receive the same routine immunization schedule and timing as for full-term births, according to their chronological age. Data regarding hexavalent vaccine safety in PTIs are still limited. We conducted a post-marketing surveillance study of the DTaP2-IPV-HB-Hib vaccine administered to PTIs in Apulia region, Italy. We identified PTIs by selecting the hospital discharge records of infants born between January and June 2017 using the DRG and ICD-9-CM codes for preterm birth, and we matched these data with records included in the regional immunization registry. We analyzed coverage and timeliness of vaccination. To investigate adverse events (AEs) after the first dose, we interviewed via phone the parents of PTIs vaccinated with at least one dose of the DTaP2-IPV-HB-Hib vaccine. At the time of our analysis (31.12.2017), 866/936 (92.5%) PTIs received the first dose of hexavalent vaccine and 539/936 (57.6%) were vaccinated by the third month of age, as recommended; 700/866 (80.8%) received the DTaP2-IPV-HB-Hib vaccine. The parents of 339 PTIs vaccinated with the DTaP2-IPV-HB-Hib vaccine reported local pain as the most common reaction (35.7% of the children). Erythema, swelling, induration and nodule were also reported in about 25% of the children. Systemic adverse events were generally rarer than local reactions. No serious AEs were reported. Our findings showed that more than 40% of PTIs received delayed hexavalent vaccination. This study showed a reassuring safety profile of the vaccine in the preterm population and may be considered as a pilot for further real-world studies. CI - Copyright (c) 2020 University of Foggia - Dept. of Medical and Surgical Sciences. Published by Elsevier Ltd.. All rights reserved. FAU - Martinelli, Domenico AU - Martinelli D AD - Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy; Department of Hygiene, Policlinico Riuniti di Foggia, Foggia, Italy. FAU - Fortunato, Francesca AU - Fortunato F AD - Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy; Department of Hygiene, Policlinico Riuniti di Foggia, Foggia, Italy. FAU - Del Matto, Giulia AU - Del Matto G AD - Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy; Department of Hygiene, Policlinico Riuniti di Foggia, Foggia, Italy. FAU - Iannelli, Giuseppina AU - Iannelli G AD - Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy; Department of Hygiene, Policlinico Riuniti di Foggia, Foggia, Italy. FAU - Prato, Rosa AU - Prato R AD - Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy; Department of Hygiene, Policlinico Riuniti di Foggia, Foggia, Italy. Electronic address: rosa.prato@unifg.it. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20200622 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (DTaP-IPV-HB-PRP-T vaccine) RN - 0 (Diphtheria-Tetanus-Pertussis Vaccine) RN - 0 (Haemophilus Vaccines) RN - 0 (Hepatitis B Vaccines) RN - 0 (Poliovirus Vaccine, Inactivated) RN - 0 (Vaccines, Combined) SB - IM MH - Child MH - Diphtheria-Tetanus-Pertussis Vaccine/adverse effects MH - Female MH - *Haemophilus Vaccines/adverse effects MH - *Haemophilus influenzae type b MH - Hepatitis B Vaccines MH - Humans MH - Immunization Schedule MH - Infant MH - Infant, Newborn MH - Infant, Premature MH - Italy MH - Poliovirus Vaccine, Inactivated/adverse effects MH - Pregnancy MH - *Premature Birth/epidemiology MH - Product Surveillance, Postmarketing MH - Vaccines, Combined/adverse effects OTO - NOTNLM OT - Adverse events OT - Hexavalent vaccine OT - Paediatrics OT - Pre-term infants OT - Safety OT - Timeliness COIS- Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Prato reports personal fees and non-financial support for attending symposia and advisory committees from Sanofi Pasteur, during the conduct of the study; personal fees and non-financial support from GSK, personal fees and non-financial support from MSD, outside the submitted work; and RP asserts to be a component of the Apulia Region Immunization Technical Advisory Group, which advises the Regional health authorities on policies of vaccination; advisory and decisional power on vaccines procurement remains solely on the Regional Government. Dr. Martinelli reports non-financial support for attending symposia from Sanofi Pasteur, during the conduct of the study; personal fees and non-financial support from GSK, personal fees and non-financial support from MSD, outside the submitted work. Dr. Fortunato reports non-financial support for attending symposia from Sanofi Pasteur, during the conduct of the study. No other competing interests are to be disclosed. EDAT- 2020/06/27 06:00 MHDA- 2021/04/28 06:00 CRDT- 2020/06/27 06:00 PHST- 2020/02/04 00:00 [received] PHST- 2020/06/04 00:00 [revised] PHST- 2020/06/10 00:00 [accepted] PHST- 2020/06/27 06:00 [pubmed] PHST- 2021/04/28 06:00 [medline] PHST- 2020/06/27 06:00 [entrez] AID - S0264-410X(20)30806-9 [pii] AID - 10.1016/j.vaccine.2020.06.033 [doi] PST - ppublish SO - Vaccine. 2020 Jul 14;38(33):5148-5153. doi: 10.1016/j.vaccine.2020.06.033. Epub 2020 Jun 22.