Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and post-implementation programmes of immunisations in pregnancy.

Survival rates for babies born extremely prematurely increased between 1995 and 2006, but few improvements in neonatal morbidity occurred despite appropriate interventions. The current study was undertaken to examine the neurologic and developmental outcomes for babies born at less than 27 weeks' gestation in 2006 and to compare the survival and outcomes at 3 years of age with those of babies born at 22 to 25 weeks' gestation in 1995.Data were collected for all babies born at 22 to 26 weeks' gestation during 2006. Families were contacted for assessment when the children were aged 30 to 36 months. In 1995, data were collected for babies born at 22 to 25 weeks' gestation. Cerebral palsy was identified by neurologic examination and classified as severe, moderate, and mild, or no impairment in motor, developmental, sensory, and communication domains. Data from these 1995 and 2006 cohorts were combined to allow comparisons after reclassification of 2006 outcomes using the 1995 definitions.A total of 576 children, aged 27 to 48 months, were evaluated in person. Information was available from local data records for another 191 children, aged 18 to 50 months, of whom 68 (38%) had neurodevelopmental impairment. Of babies born at less than 27 weeks' gestation in 2006, 77 (13.4%) had severe, and 68 (11.8%) had moderate impairment. Rates for cognitive, communication, and motor impairment were 16%, 11%, and 8%, respectively. An inverse relationship was observed between gestational age and prevalence of moderate or severe impairment, that is, 45% of survivors at 22 to 23 weeks to 30% at 24 weeks, 25% at 25 weeks, and 20% at 26 weeks. Eighty-three children had cerebral palsy, 32 (39%) with diplegia, 21 (25%) with hemiplegia, 10 (12%) with quadriplegia, and 20 (24%) with other types. Nine children (11%) with cerebral palsy had severe sensory impairment; developmental testing showed severe, moderate, or mild impairment in 47 (57%), 30 (46%), and 6 (7%) children, respectively. For births at less than 27 weeks' gestation in 2006, survival free of moderate or severe impairment ranged from 8% at 23 weeks' gestation to 59% at 26 weeks' gestation. Based on babies who received active intervention after birth, rates ranged from 11% at 23 weeks' gestation to 60% at 26 weeks' gestation and for babies receiving intensive care from 15% to 61%, respectively.When comparing to the historical cohort, survival to age 3 years for babies admitted to intensive care was 39% in 1995 and 52% in 2006. Overall, the proportion of babies admitted to intensive care who survived with severe disability increased by 2.6%, but a higher proportion survived without disability (11%). Survival without disability increased significantly at 25 and 24 weeks' gestation (15% and 10%, respectively), but changes were not statistically significant at 23 and 22 weeks' gestation (2.5% and j0.4%). In 1995, 43 children (18%) had severe disabilities, and 54 (23%) had other disabilities compared with 60 (19%) and 54 (16%), respectively, in 2006. Developmental scores of ...

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Background Concomitant seasonal influenza vaccination with a COVID-19 vaccine booster could help to minimise potential disruption to the seasonal influenza vaccination campaign and maximise protection against both diseases among individuals at risk of severe disease and hospitalisation. This study aimed to assess the safety and immunogenicity of concomitant administration of high-dose quadrivalent influenza vaccine (QIV-HD) and a mRNA-1273 vaccine booster dose in older adults. Methods This study is an ongoing, phase 2, multicentre, open-label, descriptive trial at six clinical research sites in the USA. We describe the interim results up to 21 days after vaccination (July–August, 2021). Community-dwelling adults aged 65 years and older, who were previously vaccinated with a two-dose primary schedule of the mRNA-1273 SARS-CoV-2 vaccine, were eligible for inclusion. The second dose of the primary mRNA-1273 vaccination series was required to have been received at least 5 months before enrolment in the study. Participants were randomly assigned (1:1:1) using a permuted block method stratified by site and by age group (<75 years vs ≥75 years), to receive concomitant administration of QIV-HD and mRNA-1273 vaccine, QIV-HD alone, or mRNA-1273 vaccine alone. Randomisation lists, generated by Sanofi Pasteur biostatistics platform, were provided to study investigators for study group allocation. Unsolicited adverse events occurring immediately, solicited local and systemic reactions up to day 8, and unsolicited adverse events, serious adverse events, adverse events of special interest, and medically attended adverse events up to day 22 were reported. Haemagglutination inhibition antibody responses to influenza A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains and SARS CoV-2 binding antibody responses (SARS-CoV-2 pre-spike IgG ELISA) were assessed at day 1 and day 22. All analyses were descriptive. The study is registered with ClinicalTrials.gov , NCT04969276 . Findings Between July 16 and Aug 31, 2021, 306 participants were enrolled and randomly assigned, of whom 296 received at least one vaccine dose (100 in the coadministration group, 92 in the QIV-HD, and 104 in the mRNA-1273 group). Reactogenicity profiles were similar between the coadministration and mRNA-1273 groups, with lower reactogenicity rates in the QIV-HD group (frequency of solicited injection site reactions 86·0% [95% CI 77·6–92·1], 91·3% [84·2–96·0], and 61·8% [50·9–71·9]; frequency of solicited systemic reactions 80·0%, [70·8–87·3], 83·7% [75·1–90·2], and 49·4% [38·7–60·2], respectively). Up to day 22, unsolicited adverse events were reported for 17·0% (95% CI 10·2–25·8) of participants in the coadministration group and 14·4% (8·3–22·7) of participants in the mRNA-1273 group, and tended to be reported at a slightly lower rate (10·9% [5·3–19·1]) in participants in the QIV-HD group. Seven participants e...

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