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BACKGROUND Respiratory syncytial virus (RSV) is an important cause of acute respiratory infection, lower respiratory tract disease, clinical complications, and death in older adults. There is currently no licensed vaccine against RSV infection. METHODS In an ongoing, international, placebo-controlled, phase 3 trial, we randomly assigned, in a 1:1 ratio, adults 60 years of age or older to receive a single dose of an AS01E-adjuvanted RSV prefusion F protein-based candidate vaccine (RSVPreF3 OA) or placebo before the RSV season. The primary objective was to show vaccine efficacy of one dose of the RSVPreF3 OA vaccine against RSV-related lower respiratory tract disease, confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR), during one RSV season. The criterion for meeting the primary objective was a lower limit of the confidence interval around the efficacy estimate of more than 20°6. Efficacy against severe RSV-related lower respiratory tract disease and RSV-related acute respiratory infection was assessed, and analyses according to RSV subtype (A and B) were performed. Safety was evaluated. RESULTS A total of 24,966 participants received one dose of the RSVPreF3 OA vaccine (12,467 participants) or placebo (12,499). Over a median follow-up of 6.7 months, vaccine efficacy against RT-PER-confirmed RSV-related lower respiratory tract disease was 82.6% (96.95% confidence interval [CI], 5Z9 to 94.1), with 7 cases (1.0 per 1000 participant-years) in the vaccine group and 40 cases (5.8 per 1000 participant-years) in the placebo group. Vaccine efficacy was 94.1% (95% CI, 62.4 to 99.9) against severe R.SV-related lower respiratory tract disease (assessed on the basis of clinical signs or by the investigator) and 71.7% (95% CI, 56.2 to 82.3) against RSV-related acute respiratory infection. Vaccine efficacy was similar against the RSV A and B subtypes (for RSV-related lower respiratory tract disease: 84.6% and 80.9°6, respectively; for RSV-related acute respiratory infection: 71.9% and 70.6%, respectively). High vaccine efficacy was observed in various age groups and in participants with coexisting conditions. The RSVPreF3 OA vaccine was more reactogenic than placebo, but most adverse events for which reports were solicited were transient, with mild-to-moderate severity. The incidences of serious adverse events and potential immune-mediated diseases were similar in the two groups. CONCLUSIONS A single dose of the RSVPreF3 OA vaccine had an acceptable safety profile and prevented KSV-related acute respiratory infection and lower respiratory tract disease and severe RSV-related lower respiratory tract disease in adults 60 years of age or older, regardless of RSV subtype and the presence of underlying coexisting conditions. (Funded by GlaxoSmithKline Biologicals; AReSVi-006 ClinicalTrials.gov number, NCT04886596.). [ABSTRACT FROM AUTHOR]

Objective: The objective of this study is to provide a retrospective review of the 40-year experience of three oncology referral centers in the field of reconstructive laryngeal surgery., Materials and Methods: A multi-institutional retrospective analysis included adult patients who underwent reconstructive laryngeal surgery for cT2-T4a laryngeal cancer (LC) between 1 June 1987 and 1 July 2019. Patients were stratified according to the European Laryngological Society classification for open partial horizontal laryngectomy (OPHL)., Results: The final study group included 805 patients (668 men and 137 women). 561 tumors were glottic, while 244 showed supraglottic origin; 644 were considered anterior and 161 posterior. Arytenoid motility was normal in 712 patients, while the motility of the vocal folds appeared to be impaired in 501 patients. All patients underwent OPHL, of which 20 patients underwent OPHL I, 636 patients underwent OPHL II, and 149 patients underwent type III OPHL. 257 patients underwent adjuvant RT based on multiple risk factors/pathological findings. The 5-year overall survival rate was 89.7% (95% CI 87.2-94). The 5-year disease-free survival rate was 78.4% (95% CI 76.8-84.9), and the 5-year disease-specific survival was 64.3% (95% CI 62.2-69.6). Complications were observed in 7.5% of patients, while long-term sequelae were observed in 21% of patients., Conclusion: The findings of this work reveal four decades of surgical evolution in the school of Enrico de Campora. Despite the retrospective analysis and the extremely long follow-up, our analysis shows how OPHLs play a crucial role in LC (even cT4a), with excellent results in terms of functional outcome and organ preservation., (© 2024 Wiley Periodicals LLC.)

Background: The purpose of this multicenter study was to retrospectively investigate the prognostic significance of the tumor microenvironment, in relation to survival in a large cohort of patients with laryngeal squamous cell carcinoma (LSCC), using the method proposed by the International TILs Working Group in breast cancer., Methods: All consecutive patients with biopsy-proven LSCC who underwent total laryngectomy (TL) between January 2014 and January 2023 were retrospectively included in the study. A retrospective review of medical records including surgical, pathological and follow-up reports was performed. The density of TILs was determined according to the recommendations of the International TILs Working Group., Results: The study group included 186 patients with LSCC. High TILs were statistically correlated with reduced size and extension of primary tumor (pT stage) with a statistically significant value (S: p = 0.01; P: p = 0.0003) and without needs of salvage therapy (S: p = 0.03; P: p = 0.004). Low TILs were indicative of worse prognosis., Conclusions: Our study confirmed the protective value of TILs and the prognostic role of the tumor microenvironment in LSCC; furthermore, our results showed that the score proposed by the International TILs Working Group for breast cancer can be applied to LSCC., (© 2024 Wiley Periodicals LLC.)

Our objective was to investigate the effects of intravenous (IV) or intrauterine (IU) lipopolysaccharide (LPS) challenge at 5 or 40 d postpartum (DPP) on clinical signs, systemic and uterine inflammation, dry matter intake (DMI), and milk yield (MY). Holstein cows at 5 DPP (n = 23) or at 40 DPP (n = 24) were blocked by parity and randomly assigned to 1 of 3 treatments: (1) IV-LPS (0.0625 μg/kg BW [5 DPP] or 0.1 μg/kg BW [40 DPP] over 1h), (2) IU-LPS (100 μg [5 DPP] or 300 μg [40 DPP] in 20 mL of saline), or (3) 20 mL of saline IU (IU-SAL; same for 5 and 40 DPP). The proportion of polymorphonuclear (PMN) cells was measured by endometrial cytology at d -1, 1, 4, and 7 relative to treatment. Blood haptoglobin (Hp), serum amyloid A (SAA), and LPS-binding protein (LBP), DMI, and MY were measured from d -1 through d 7. Data were analyzed separately for each DPP group in multivariable linear regression models accounting for repeated measures. Both DPP groups showed increases in rectal temperature and heart and respiratory rates, and decrease in rumination rate following IV-LPS, but not following IU-LPS. At 5 DPP, endometrial PMN proportion was similar in IU-LPS and IU-SAL. Serum Hp was unaffected by LPS challenge, SAA was greater in IV-LPS from 12 h to 24 h after challenge, and LBP was greater in IV-LPS from 8 h to 24 h. At 40 DPP, PMN was greater in IU-LPS (37 ± 4%) than in IU-SAL (15 ± 4%) 1 d after LPS challenge. Serum Hp was greater from 24 h to 72 h after challenge in IV-LPS than in the other groups, SAA was greater in IV-LPS from 6 h to 48 h, and LBP was greater in IV-LPS from 8 h to 24 h. At both 5 and 40 DPP, treatment did not affect DMI, but MY was lesser in IV-LPS cows at 12 h and 24 h than in IU-SAL or IU-LPS. The IV-LPS challenge resulted in more pronounced changes in clinical signs and acute phase protein (APP) concentrations than IU-LPS or IU-SAL at 40 DPP, but more subtle or inconsistent changes at 5 DPP. These may be due to the different doses of LPS used at 5 and 40 DPP or possibly due to the high variation in baseline clinical signs and APP observed in all groups at 5 DPP. The IU-LPS increased uterine PMN 1 d after challenge at 40 DPP but not at 5 DPP. At each time, IU-LPS did not produce changes in clinical signs or markers of systemic inflammation., (The Authors. Published by Elsevier Inc. on behalf of the American Dairy Science Association®. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).)

Background: This study aims to retrospectively investigate the prognostic significance of the tumor microenvironment, with a focus on TILs (tumor-infiltrating lymphocytes), in relation to survival in a large cohort of patients with parotid gland cancer, and it uses the method proposed by the International TILs Working Group in breast cancer. Methods: We included a cohort of consecutive patients with biopsy-proven parotid cancer who underwent surgery between January 2010 and September 2023. A retrospective review of medical records, including surgical, pathological and follow-up reports, was performed. The density of TILs was determined according to the recommendations of the International TILs Working Group for breast cancer. Results: A weak negative correlation ( p = 0.3) between TILs and time of survival and a weak positive correlation ( p = 0.05) between TILs and months of survival (high TILs were correlated with longer survival in months) were identified. High TILs were weakly negatively, but not statistically significantly p (0.7), correlated with the grading of tumor; this means that high TILs were associated with low-grade tumors. Conclusions: Contrary to previous preliminary reports, this retrospective work found no statistically significant prognostic role of TILs in parotid gland malignancies. This case series represents the largest cohort ever reported in the literature and includes all malignant histological types. Future larger molecular studies may be useful in this regard.

To assess the effectiveness of intraoperative facial nerve monitoring (IFNM) compared to non-monitoring in the prevention of post-operative facial nerve palsy during superficial parotidectomy. Patients treated with curative intent for parotid gland tumors between January 2020 and January 2022 were included. The study population has been divided in 2 groups, based on IFNM: the group A included patients operated with IFNM, whilst group B was the non-monitoring group. A further classification focused on the pathologies and the surgeons' experience. The study group included 58 patients, 27 female and 31 male. The mean age was 45.7 yr (range 36-78). No statistical difference has been found in post-operative HB grade between group A and B. The analysis of patients affected by pleomorphic surface lobe adenomas of the parotid did not show a statistical difference in HB outcome ( p  > 0.05). The analysis of the effect of surgeons' experience in IFNM advantage did not show statistical difference for superficial parotid tumors. The results of the present study suggest that the use of IFNM during parotid surgery is not mandatory to preserve the VII nerve function, both in case of primary tumor and in case of recurrence, and even when surgery is performed by less experienced surgeon compared to those cases treated by a more experienced surgeon., Competing Interests: Conflict of interestNo conflict to disclose, (© Association of Otolaryngologists of India 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.)

Background: The acinic cell carcinoma (AciCC) of the parotid gland is a rare tumor with an indolent behavior; however, a subgroup of this tumor presents an aggressive behavior with a tendency to recur. The aim of this multicenter study was to identify and stratify those patients with AciCC at high risk of tumor recurrence., Methods: A retrospective study was carried out involving 77 patients treated with surgery between January 2000 and September 2022, in different Italian referral centers. Data about tumor characteristics and its recurrence were collected. The histological specimens and slides were independently reviewed by a senior pathologist coordinator (L.C.) and the institution's local head and neck pathologist., Results: The patients' age average was 53.6 years, with a female prevalence in the group. The mean follow-up was 67.4 months (1-258, SD 59.39). The five-year overall survival (OS) was 83.2%. The 5-year disease-free survival (DFS) was 60% (95% CI 58.2-61.7). A high incidence of necrosis, extraglandular spread, lymphovascular invasion (LVI), atypical mitosis, and cellular pleomorphism was observed in the high-risk tumors compared to the low-risk ones., Conclusion: AciCC generally had an indolent behavior, optimal OS, DFS with few cervical node metastases, and rare distant relapses. This multicenter retrospective case series provides evidence of the need for clinical-epidemiological-histological stratification for patients at risk of poor outcomes. Our results suggest that the correct definition of high-risk AciCC should include tumor size, the presence of necrosis, extraglandular spread, LVI, atypical mitosis, and cellular pleomorphism.

Introduction: To retrospectively analyzed our twenty-years single-center experience in the treatment of PPS tumors, focusing on the selection of surgical approach and the survival outcome., Methods: Tumors involving the PPS between January 2000 and February 2022 were retrospectively included. The surgical approach was dictated by the localization of the tumor, its dimensions, the relation to anatomic structures and its etiology., Results: 34 patients were included in the study. The median age was 50.5 yr, with a gender female prevalence. Most tumors were benign and non recurrent. 20 tumors were treated through lateral approach (transcervical or transcervical-transparotid), 11 through medial approach (transoral), and only 3 tumors were approached by multiple corridors. The 5 years disease free survival (DFS) was 78.8 % (CI 78-79.3 %)., Conclusions: In our experience, the transcervical and transoral approaches can be considered the ideal surgical approach to manage tumors of PPS, especially in cases of benign neoplasms., (Copyright © 2022. Published by Elsevier Inc.)

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Introduction: This observational retrospective matched cohort study evaluated the safety of a prenatal tetanus, diphtheria, acellular pertussis (Tdap) vaccination, Boostrix. We previously reported on the risk of maternal and neonatal outcomes; here we report on the risk of congenital anomalies in infants at birth through 6 months of age., Methods: The study included pregnant Kaiser Permanente Southern California members. Women who received the Tdap vaccine on or after the 27th week of pregnancy between January 2018 and January 2019 were matched to women who were pregnant between January 2012 and December 2014 and were not vaccinated with Tdap during pregnancy. Unadjusted and adjusted relative risks (aRRs) with 95% confidence intervals were estimated by Poisson regression. Quantitative secular trend analyses, from 2011 to 2017, were conducted on congenital anomalies with a statistically significant aRR > 1., Results: The analysis consisted of 16,350 and 16,088 live-born infants in the Tdap-exposed and unexposed cohorts, respectively. Of the 14 congenital anomaly body systems evaluated, 8 (eye, ear/face/neck, respiratory, upper gastrointestinal, genital, renal, musculoskeletal, integument) had statistically significant elevated aRRs, with point estimates ranging from 1.17 to 2.02. The observed elevated aRRs were consistent with their respective secular increases over time., Conclusion: Cautious interpretation of these findings is warranted as these increases may have resulted from improved identification and diagnosis. Furthermore, the biological plausibility of an association between maternal vaccine exposure in the third trimester of pregnancy and birth defects is low. The overall study findings support the safety of maternal immunization with Boostrix during the third trimester of pregnancy., Trial Registration: ClinicalTrials.gov identifier, NCT03463577., (© 2022. The Author(s).)

(1) Objective: This prospective case-control study aimed to assess the level of serum vitamin D comparing pediatric non-allergic patients with obstructive sleep apnea (OSA) and healthy controls. (2) Methods: The period of the enrollment was from November 2021 to February 2022. Children with uncomplicated OSA caused by adenotonsillar hypertrophy (ATH) were recruited. Allergy was excluded by skin prick test (SPT), and the determination of serum IgE level using ELISA test. Plasma concentration of 25-hydroxy vitamin D (25-OHD) was quantitatively determined; then, the vitamin D concentration in patients was compared with healthy controls matched for sex, age, ethnicity, and characteristics. (3) Results: Plasma 25-OHD levels were significantly lower in patients than in healthy subjects (mean 17 ng/mL, 6.27 DS, range 6-30.7 ng/mL, vs. mean 22 ng/mL, 9.45 DS, range 7-41.2 ng/ ml; p < 0.0005). The prevalence of children with vitamin D deficiency was significantly higher in the ATH group than controls. The plasma 25-OHD level did not change following the ATH clinical presentation (III or IV grade according to the Brodsky scale), while the different categories of 25-OHD status (insufficiency, deficiency, and adequacy) in the ATH group were statistically significantly different ( p < 0.001) from healthy controls. (4) Conclusions: This study identified statistically significant differences between the ATH group and control regarding the plasma concentration of vitamin D; this data, despite not being directly linkable to the lymphoid tissue hypertrophy ( p -value not significant), might suggest a negative effect of vitamin D deficit on the immune system.

Objectives: To analyze the demographic data, surgical and adjuvant treatment data and the survival outcomes in adult patients affected by acinic cell carcinoma of the parotid gland (AciCC)., Methods: A retrospective multicenter analysis of patients treated for AciCC of the parotid gland from 2000 to 2021 was performed. Exclusion criteria were pediatric (0-18 years) patients, the absence of follow-up and patients with secondary metastatic disease to the parotid gland. Multivariable logistic regression was used to determine factors associated with survival., Results: The study included 81 adult patients with AciCC of the parotid gland. The median age was 46.3 years (SD 15.81, range 19-84 years), with a gender female prevalence (F = 48, M = 33). The mean follow-up was 77.7 months (min 4-max 361, SD 72.46). The 5 years overall survival (OS) was 97.5%. The 5 years disease-free survival (DFS) was 60%. No statistical differences have been found in prognosis for age (< 65 or ≥ 65 years), sex, surgery type (superficial vs profound parotid surgery), radicality (R0 vs R1 + Rclose), neck dissection, early pathologic T and N stages and adjuvant therapy (p > 0.05)., Conclusion: This study did not find prognostic factor for poorest outcome. In contrast with the existing literature, our results showed how also high-grade tumours cannot be considered predictive of recurrence or aggressive behaviour., (© 2022. The Author(s).)

The objective of this study was to evaluate the safety of prenatal tetanus, diphtheria, acellular pertussis (Tdap) vaccination. This cohort study was conducted among pregnant members at Kaiser Permanente Southern California (KPSC). The exposed cohort consisted of women who received Tdap vaccine on or after the 27th week of pregnancy between January 2018 and January 2019. The unexposed cohort consisted of matched women who were pregnant between January 2012 and December 2014 and were not vaccinated with any Tdap vaccine throughout their pregnancy. Maternal and infant characteristics and pre-specified endpoints were collected through automated data and review of the electronic health records. Unadjusted and adjusted relative risks (aRRs) with confidence intervals (CIs) were estimated by Poisson regression. Non-inferiority testing (i.e., to rule out a two-fold increase) was conducted for primary endpoints with adjustment for multiplicity. Superiority testing was conducted without multiplicity adjustment for secondary endpoints. The analysis consisted of 16,606 pairs of Tdap recipients and unexposed pregnant women. For the primary endpoints, the aRR for preeclampsia/eclampsia was 1.38 (98.75% CI:1.21-1.58) and the aRR for intrauterine infection was 1.28 (98.75% CI:1.12-1.47). These increases were consistent with the background increasing trend of these diagnoses among all pregnant women at KPSC since 2011, and the upper limit of the 98.75% CI of both aRRs did not exceed the pre-specified threshold of 2. No increased risks of small for gestational age (aRR = 1.04, 98.75% CI:0.94-1.16) or preterm delivery (aRR = 0.71, 98.75% CI:0.64-0.78) were observed. No evidence of increased risks for secondary endpoints, including poor fetal growth, preterm pre-labor rupture of membranes, stillbirth/fetal death, placental abruption, transfusion during delivery hospitalization, and neonatal death, was observed. Prenatal Tdap vaccination after the 27th week of pregnancy was not associated with increased risks of pre-specified maternal and infant outcomes, supporting the safety of Tdap vaccination during pregnancy., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Hung Fu Tseng reports financial support was provided by GSK Vaccines. Hung Fu Tseng reports a relationship with Moderna Therapeutics Inc that includes: funding grants. HFT, GSL, and YT received research funding from GSK group of companies and Moderna for other studies outside of the submitted work. LSS received research funding from GSK group of companies, Novavax, Seqirus, Dynavax, and Moderna for other studies outside of the submitted work. BKA received research funding from GSK group of companies, Novavax, Seqirus, Dynavax, Moderna, Pfizer, and Genentech for other studies outside of the submitted work. YL received research funding from GSK group of companies, Seqirus, Moderna, and Pfizer for other studies outside of the submitted work. AF received research funding from GSK group of companies, Moderna, Pfizer, and Gilead for other studies outside of the submitted work. TBC received research funding from GSK group of companies for other studies outside of the submitted work. SYT received research funding from Pfizer for other studies outside of the submitted work. CT received research funding from GSK and Novavax for other studies outside of the submitted work. LC, MAC, AK, LV, BC, NMeyer and AG are employees of the GSK group of companies. LC, MAC, AK, LV, BC, NMeyer and AG hold shares in the GSK group of companies. JEP, DR and NMesaros were employees of the GSK group of companies and held shares at the time of this study. The authors have no non-financial competing interest to declare. LQ received research funding from GSK group of companies, Moderna, and Dynavax for other studies outside of the submitted work.]., (Copyright © 2022 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Cribriform adenocarcinoma of the tongue and minor salivary glands (CATMSG) is a rare neoplasm, accounting for less than 1% of salivary gland tumors. In the past it has been considered a possible variant of polymorphous low-grade adenocarcinoma (PLGA), while nowadays it is accepted as a provisional entity in the WHO classification. The aim of this paper is to systematically review the existing literature about CATMSG with a particular attention to differential diagnosis and prognostic factors., Methods: This study was performed in accordance with the PRISMA checklist. A comprehensive search in PubMed, Cochrane, and Google Scholar databases was carried out in June 2021, in partnership with a medical librarian, without time restriction. Search items include the following keywords: "cribriform adenocarcinoma of the tongue" OR "cribriform adenocarcinoma of the tongue and minor salivary glands.", Results: A total of 56 patients were evaluated. Patient age across the studies ranged from 13 to 85 years (mean 59.6 year). The most common site of involvement was the tongue (58.9%), followed by palate (19.6%), tonsil (7.1%), buccal (3.6%) and reticular mucosa (3.6%), lip (3.6%), retromolar pad (1.7%), and floor of the mouth (1.7%). Lymph node involvement at the diagnosis was very common (58.9%), while there was no evidence of patients diagnosed with metastatic disease. The most common surgical approach was surgical excision (17, 30.3%); neck dissection was performed in 16 patients (28%). Radiotherapy was the most common adjuvant treatment reported (46.4%); only one patient underwent adjuvant chemotherapy (1.7%). Five patients experienced a recurrence (8.8%)., Conclusion: To our knowledge, only 56 five cases of CATMSG have been previously described. The results of this review seem to confirm the low frequency of relapses and distant metastases, but we observed that almost 60% of cases presented with cervical lymph node involvement. In our opinion, CATMSG should be considered as a distinct tumor entity from PLGA., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

The aim of this paper is to present the clinical features and the diagnostic and surgical management of a 92-year-old patient with giant goiter. She was admitted to our Emergency Department for evaluation of a cervical mass increased in volume over the past five years. She complained of mild dyspnea pressure symptoms in the neck. Neck and mediastinal noncontrast computed tomography showed a huge goiter with a clear prominent right thyroid lobe, with external compression of the trachea. Consequently, she underwent a right thyroid lobectomy. Patient followed up closely; she is asymptomatic with no evidence of recurrence on RAI scan at the end of six months follow-up. In conclusion, the treatment choice for elderly patients with FTC should be based on medical assessments; in these patients, especially those with larger goiter and compressive symptoms, surgery is the first choice. KEY WORDS: Elderly, Emergency Surgery, Follow up, Thyroid carcinoma, Thyroid lobectomy.

The auto-immune correlation between sensorineural hearing loss and celiac disease has previously been hypothesized. This review describes available evidence and offers insights for future perspectives. We searched the PubMed database. Studies in the review included children and adults with celiac disease evaluated for hearing loss. Individual case reports and review articles were excluded. The various searches turned in 32 results, of which 10 met the inclusion criteria. Auto-immune hearing loss has been proposed as extra- intestinal symptoms of celiac disease, despite the pathogenetic mechanisms being not entirely clear. Several studies postulated that subclinical hearing loss may be present in children with celiac disease. Despite existing literature not clarifying the link between celiac disease and sensorineural hearing loss, some authors proposed hearing screening in younger patients with celiac disease, to prevent the behavioral, cognitive, and sensorimotor impairment of hearing loss. Further rigorous studies are strongly recommended to better explore the relationship between hearing loss and celiac disease.

Background: GSK initiated a Pregnancy Registry in the United States (US) for the reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap; Boostrix, GSK) vaccine with the aim to detect and describe pregnancy outcomes in women vaccinated with Boostrix 28 days before estimated conception or during pregnancy., Methods: Voluntary reports of pregnancy exposure to Boostrix received from spontaneous and post-marketing surveillance sources in the US were assessed. Reports were classified as prospective or retrospective based on the knowledge of pregnancy outcomes at the time of reporting. For completeness, reports of exposure to Boostrix or to the Tdap-inactivated poliovirus vaccine (Boostrix-IPV, GSK) reported to the global safety database from countries outside the US were also evaluated., Results: From May 2005 to August 2019, 1517 (1455 prospective and 62 retrospective) pregnancy reports were received in the Boostrix US Pregnancy Registry. Of the prospective reports, 250 had known outcomes: 244 live infants with no apparent birth defects (BDs), three live infants with BDs, and three spontaneous abortions with no apparent BDs. Of the retrospective reports, 55 had known outcomes: 33 live infants with no apparent BDs, 16 live infants with BDs, one spontaneous abortion with no apparent BDs, four stillbirths with no apparent BDs, and one stillbirth with BDs. Cumulatively, 1321 pregnancy reports (1006 for Boostrix; 315 for Boostrix-IPV) were received from countries outside the US. Of these, 163 prospective reports and 551 retrospective reports had known outcomes. Results were in line with those from the Boostrix US Pregnancy Registry., Conclusions: Data currently available from the Boostrix US Pregnancy Registry and from countries outside the US suggested that exposure to Boostrix or Boostrix-IPV during pregnancy does not raise safety concerns related to adverse pregnancy outcomes or BDs., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: AJ is employee of the GSK group of companies. AK, LC, MAC, and FTDS are employees of the GSK group of companies and have shares in the GSK group of companies. The authors declare no non-financial relationships and activities. All authors attest they meet the ICMJE criteria for authorship., (Copyright © 2022 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.. All rights reserved.)