PMID- 36604217 OWN - NLM STAT- MEDLINE DCOM- 20230202 LR - 20230203 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 41 IP - 5 DP - 2023 Jan 27 TI - Reactogenicity and safety of second trimester maternal tetanus, diphtheria and acellular pertussis vaccination in the Netherlands. PG - 1074-1080 LID - S0264-410X(22)01596-1 [pii] LID - 10.1016/j.vaccine.2022.12.061 [doi] AB - BACKGROUND: Maternal tetanus-diphtheria-and-acellular-pertussis (Tdap) vaccination is offered to all pregnant women during their second trimester in the Netherlands since December 2019. We assessed second trimester Tdap vaccination reactogenicity and compared with third trimester data from a similar study. For safety assessment, adverse pregnancy outcomes were compared with national data from 2018, before Tdap vaccine-introduction. METHODS: Pregnant women were included between August 2019-December 2021 and received Tdap vaccination between 20 and 24w gestational age (GA). Participants completed a questionnaire on solicited local reactions and systemic adverse events (AEs) within one week after vaccination. Results were compared with historical data on reactogenicity from women vaccinated between 30 and 33w GA (n = 58). Regarding safety-related outcomes, each participant was matched to four unvaccinated pregnant women from the Dutch Perinatal Registry, based on living area, parity and age. RESULTS: Among 723 participants who completed the questionnaire, 488 (67.5 %) experienced >/= 1 local reaction with pain at the injection site as most reported reaction (62.3 %), and 460 (63.6 %) experienced >/= 1 systemic AE with stiffness in muscles/joints (38.9 %), fatigue (28.9 %), headache (14.5 %) and common cold-like symptoms (11.0 %) most frequently reported. 4 women (0.6 %) reported fever (>/=38.0 C). Symptoms were considered mild and transient within days. No difference in AEs were found between vaccination at 20-24w versus 30-33w GA. 723 participants were matched to 2,424 unvaccinated pregnant women with no increased rates of premature labor, small-for-gestational-age, or other adverse pregnancy outcomes. CONCLUSIONS: Second trimester maternal Tdap vaccination appears safe and well-tolerated. Comparison between second versus third trimester vaccination yielded no reactogenicity concerns. CI - Copyright (c) 2023 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Immink, Maarten M AU - Immink MM AD - Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3720 MA Bilthoven, the Netherlands; Department of Obstetrics, Wilhelmina Children's Hospital, University Medical Center Utrecht, and Utrecht University, Utrecht, the Netherlands. FAU - Kemmeren, Jeanet M AU - Kemmeren JM AD - Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3720 MA Bilthoven, the Netherlands. FAU - Broeders, Lisa AU - Broeders L AD - The Dutch Perinatal Registry, Perined, Utrecht, the Netherlands. FAU - Bekker, Mireille N AU - Bekker MN AD - Department of Obstetrics, Wilhelmina Children's Hospital, University Medical Center Utrecht, and Utrecht University, Utrecht, the Netherlands. FAU - de Melker, Hester E AU - de Melker HE AD - Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3720 MA Bilthoven, the Netherlands. FAU - Sanders, Elisabeth A M AU - Sanders EAM AD - Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3720 MA Bilthoven, the Netherlands; Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, and Utrecht University, Utrecht, the Netherlands. FAU - van der Maas, Nicoline A T AU - van der Maas NAT AD - Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3720 MA Bilthoven, the Netherlands. Electronic address: nicoline.van.der.maas@rivm.nl. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230104 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines) RN - 0 (Bacterial Vaccines) SB - IM MH - Female MH - Humans MH - Pregnancy MH - *Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse effects MH - *Diphtheria/prevention & control MH - *Tetanus/prevention & control MH - *Whooping Cough/prevention & control MH - Pregnancy Trimester, Second MH - Netherlands/epidemiology MH - Vaccination/adverse effects MH - Bacterial Vaccines OTO - NOTNLM OT - Maternal vaccination OT - Pertussis OT - Pregnancy OT - Reactogenicity OT - Safety COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2023/01/06 06:00 MHDA- 2023/02/03 06:00 CRDT- 2023/01/05 21:54 PHST- 2022/09/30 00:00 [received] PHST- 2022/12/21 00:00 [revised] PHST- 2022/12/24 00:00 [accepted] PHST- 2023/01/06 06:00 [pubmed] PHST- 2023/02/03 06:00 [medline] PHST- 2023/01/05 21:54 [entrez] AID - S0264-410X(22)01596-1 [pii] AID - 10.1016/j.vaccine.2022.12.061 [doi] PST - ppublish SO - Vaccine. 2023 Jan 27;41(5):1074-1080. doi: 10.1016/j.vaccine.2022.12.061. Epub 2023 Jan 4.