Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial.

Objective: To evaluate descriptive efficacy data, exploratory immunogenicity data, and safety follow-up through study completion from the global, phase 3 MATISSE (Maternal Immunization Study for Safety and Efficacy) maternal vaccination trial of bivalent respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVpreF).

Methods: MATISSE was a phase 3, randomized, double-blinded, placebo-controlled trial. Healthy pregnant participants aged 49 years or younger at 24-36 weeks of gestation were randomized (1:1) to receive a single RSVpreF 120 micrograms or placebo dose.

Preterm Birth Frequency and Associated Outcomes From the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Trial of the Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine.

Objective: To describe preterm birth frequency and newborn and infant outcomes overall and among preterm children in the MATISSE (Maternal Immunization Study for Safety and Efficacy) trial of maternal vaccination with bivalent respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVpreF) to protect infants against severe RSV-associated illness.

Methods: MATISSE was a global, phase 3, randomized, double-blind trial. Pregnant individuals received single injections of RSVpreF or placebo.

Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants.

Background: Whether vaccination during pregnancy could reduce the burden of respiratory syncytial virus (RSV)-associated lower respiratory tract illness in newborns and infants is uncertain.

Methods: In this phase 3, double-blind trial conducted in 18 countries, we randomly assigned, in a 1:1 ratio, pregnant women at 24 through 36 weeks' gestation to receive a single intramuscular injection of 120 μg of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine or placebo. The two primary efficacy end points were medically attended severe RSV-associated lower respiratory tract illness and medically attended RSV-associated lower respiratory tract illness in infants within 90, 120, 150, and 180 days after birth.

Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age.

Background: Safe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children.

Methods: We conducted a phase 1 dose-finding study and are conducting an ongoing phase 2-3 safety, immunogenicity, and efficacy trial of the BNT162b2 vaccine in healthy children 6 months to 11 years of age. We present results for children 6 months to less than 2 years of age and those 2 to 4 years of age through the data-cutoff dates (April 29, 2022, for safety and immunogenicity and June 17, 2022, for efficacy).

Development of PIVOT with MI: A motivational Interviewing-Based vaccine communication training for pediatric clinicians.

Delay or refusal of childhood vaccines is common and may be increasing. Pediatricians are parents' most trusted source for vaccine information, yet many struggle with how to communicate with parents who resist recommended vaccines. Evidence-based communication strategies for vaccine conversations are lacking.

Parent Attitudes Towards Childhood Vaccines After the Onset of SARS-CoV-2 in the United States.

Objective: To understand the influence of a novel infectious disease epidemic on parent general attitudes about childhood vaccines.

Methods: We conducted a natural experiment utilizing cross-sectional survey data from parents of infants in Washington and Colorado participating in a larger trial that began on September 27, 2019. At enrollment, parents completed the short version of the Parental Attitudes about Childhood Vaccines (PACV-SF), a validated survey scored from 0 to 4, with higher scores representing more negative attitudes.

Understanding Variation in Rotavirus Vaccine Effectiveness Estimates in the United States: The Role of Rotavirus Activity and Diagnostic Misclassification.

Background: Estimates of rotavirus vaccine effectiveness (VE) in the United States appear higher in years with more rotavirus activity. We hypothesized rotavirus VE is constant over time but appears to vary as a function of temporal variation in local rotavirus cases and/or misclassified diagnoses.

Methods: We analyzed 6 years of data from eight US surveillance sites on 8- to 59-month olds with acute gastroenteritis symptoms.

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.

Background: Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.

Methods: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children.

Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine.

Background: The safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known.

Methods: In this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we investigated the safety, vaccine efficacy, and immunogenicity of two doses of AZD1222 as compared with placebo in preventing the onset of symptomatic and severe coronavirus disease 2019 (Covid-19) 15 days or more after the second dose in adults, including older adults, in the United States, Chile, and Peru.

Results: A total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants).

"It's Like 1998 Again": Why Parents Still Refuse and Delay Vaccines.

We conducted a qualitative study from 2018 to 2019 to update the reasons why US parents' refuse or delay vaccines. Four focus groups and 4 semi-structured interviews involving 33 primary care pediatric providers were conducted in Washington and Colorado. A thematic analysis was conducted to identify themes related to reasons for parental refusal or delay.

Capacity Building for a New Multicenter Network Within the ECHO IDeA States Pediatric Clinical Trials Network.

Research capacity building is a critical component of professional development for pediatrician scientists, yet this process has been elusive in the literature. The ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) seeks to implement pediatric trials across medically underserved and rural populations. A key component of achieving this objective is building pediatric research capacity, including enhancement of infrastructure and faculty development.

Vaccine Effectiveness Against Pediatric Influenza Hospitalizations and Emergency Visits.

Background: Influenza A(H1N1)pdm09 viruses initially predominated during the US 2018-2019 season, with antigenically drifted influenza A(H3N2) viruses peaking later. We estimated vaccine effectiveness (VE) against laboratory-confirmed influenza-associated hospitalizations and emergency department (ED) visits among children in the New Vaccine Surveillance Network.

Methods: We tested children 6 months to 17 years with acute respiratory illness for influenza using molecular assays at 7 pediatric hospitals (ED patients <5 years at 3 sites).

A randomized controlled trial of an online immunization curriculum.

Introduction: Immunization education for physicians-in-training is crucial to address vaccine concerns in clinical practice. Vaccine education is not standardized across residency programs. The Collaboration for Vaccination Education and Research (CoVER) team developed an online curriculum for pediatric (Peds) and family medicine (FM) residents.

'Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing' (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention.

Introduction: A key contributor to underimmunisation is parental refusal or delay of vaccines due to vaccine concerns. Many clinicians lack confidence in communicating with vaccine-hesitant parents (VHP) and perceive that their discussions will do little to change parents' minds. Improving clinician communication with VHPs is critical to increasing childhood vaccine uptake.

Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016.

Background: Respiratory syncytial virus (RSV) is a major cause of hospitalized acute respiratory illness (ARI) among young children. With RSV vaccines and immunoprophylaxis agents in clinical development, we sought to update estimates of US pediatric RSV hospitalization burden.

Methods: Children <5 years old hospitalized for ARI were enrolled through active, prospective, population-based surveillance from November 1, 2015, to June 30, 2016, at 7 US pediatric hospital sites.

Detection of by Real-time PCR in Young Children Does Not Predict Disease.

Objectives: Diagnosing infections in young children with high asymptomatic colonization is challenging. We compared the frequency of detection by polymerase chain reaction (PCR) in healthy control (HC) children with those with acute gastroenteritis (AGE) and evaluated fecal-lactoferrin and organism load as possible indicators of true infection disease.

Methods: Stool was collected from children <2 years old with AGE and from HCs.

Determining the Instructional Effectiveness of Online Vaccine Education Modules: A Focus-Group Analysis.

This article was migrated. The article was marked as recommended. Vaccine education for pediatric and family medicine residents is inadequate.

Safety and immunogenicity of unadjuvanted subvirion monovalent inactivated influenza H3N2 variant (H3N2v) vaccine in children and adolescents.

Objective: In response to the emergence of influenza viruses with pandemic potential, we evaluated a swine-origin influenza A/H3N2 variant (H3N2v) vaccine in children.

Study Design: This multicenter phase II open-label study assessed the safety and immunogenicity of two doses, 21 days apart, of investigational unadjuvanted subvirion monovalent inactivated H3N2v vaccine administered via intramuscular injection. Children 6-35 months of age received 7.

Pediatric Mucormycosis: A 10-Year Systematic Review of Reported Cases and Review of the Literature.

Mucormycosis is a severe infection that affects a variety of patients, including immunocompromised children and neonates. Given improved survival rates from advances in the treatment of malignancies, the population at risk for mucormycosis is increasing. We conducted a systematic review of cases of mucormycosis in children in the English-language literature reported between August 2008 and June 2017 and analyzed the clinical characteristics, diagnosis, management, and outcome of those infections.

Neutralizing Antibody against Enterovirus D68 in Children and Adults before 2014 Outbreak, Kansas City, Missouri, USA.

We evaluated enterovirus D68 seroprevalence in Kansas City, Missouri, USA, from samples obtained during 2012-2013. Neutralizing antibodies against Fermon and the dominant 2014 Missouri isolate were universally detected. Titers increased with age.

Mupirocin for Decolonization of Infants in Neonatal Intensive Care Units.

Unlabelled: : media-1vid110.1542/5849573989001PEDS-VA_2018-1565 BACKGROUND AND OBJECTIVES: (SA) is the second leading cause of late-onset sepsis among infants in the NICU. Because colonization of nasal mucosa and/or skin frequently precedes invasive infection, decolonization strategies, such as mupirocin application, have been attempted to prevent clinical infection, but data supporting this approach in infants are limited.