A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX™) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R™ II).

The varicella vaccine passage extension (VAR-PE) process was undertaken to extend the availability of varicella zoster virus (VZV)-containing vaccines. This study (V210-A03; NCT03239873) assessed the immunogenicity, safety, and tolerability of VAR-PE process in comparison with varicella vaccine commercial product 2016 (VAR) randomized 1:1 in 600 healthy children 12 to 23 months of age administered concomitantly with measles-mumps-rubella (MMR) vaccine. The VZV seroconversion rate at 6 weeks Postdose 1 in the PP population was 100% for both groups. VZV antibody response rates and GMTs of VZV antibodies to VAR-PE induced and were non-inferior to those induced by VAR 6 weeks Postdose 1. From Day 1 through Day 42, adverse events (AEs) were reported by 81.3% of participants Postdose 1 and 67.9% Postdose 2. From Day 1 through Day 42 Postdose 1, injection-site AEs related to varicella vaccine were reported by 31.1% and 29.7% of participants in VAR-PE and VAR, respectively, and Postdose 2, by 25.7% and 25.5% of participants in the VAR-PE and VAR groups, respectively. Systemic AEs were generally comparable for the 2 vaccination groups, with the exception of pyrexia and otitis media higher in VAR-PE, and diarrhea and teething higher in VAR. The incidence of systemic AEs was generally lower Postdose 2 compared with Postdose 1.

Growth and tolerance of infants fed formula with a new algal source of docosahexaenoic acid: Double-blind, randomized, controlled trial.

Docosahexaenoic acid (DHA) in infant formula at concentrations based on worldwide human milk has resulted in circulating red blood cell (RBC) lipids related to visual and cognitive development. In this study, infants received study formula (17mg DHA/100kcal) with a commercially-available (Control: n=140; DHASCO®) or alternative (DHASCO®-B: n=127) DHA single cell oil from 14 to 120 days of age. No significant group differences were detected for growth rates by gender through 120 days of age. Blood fatty acids at 120 days of age were assessed by capillary column gas chromatography in a participant subset (Control: n=34; DHASCO-B: n=27). The 90% confidence interval (91-104%) for the group mean (geometric) total RBC DHA (µg/mL) ratio fell within the pre-specified equivalence limit (80-125%), establishing study formula equivalence with respect to DHA. This study demonstrated infant formula with DHASCO-B was safe, well-tolerated, and associated with normal growth. Furthermore, DHASCO and DHASCO-B represented equivalent sources of DHA as measured by circulating RBC DHA.

BD Veritor System Respiratory Syncytial Virus Rapid Antigen Detection Test: Point-of-Care Results in Primary Care Pediatric Offices Compared With Reverse Transcriptase Polymerase Chain Reaction and Viral Culture Methods.

BACKGROUND: During respiratory syncytial virus season, many children present to pediatric offices and urgent care medical facilities with cough, tachypnea, intercostal retraction, wheezing, as well as disturbed appetite and sleep. Identification of the responsible viral pathogen is quite difficult because several pathogens can produce similar signs and symptoms. METHODS: Nasopharyngeal specimens were collected from symptomatic sick children younger than 6 years, in 8 geographically representative primary care pediatric practices during a 4-month RSV season. Institutional review board approval and signed parental consent were obtained. The primary objective of the study was the estimation of the sensitivity and specificity of the Becton Dickinson (BD) Veritor RSV point-of-care (POC) assay as compared with reverse transcriptase-polymerase chain reaction (RT-PCR). RESULTS: Of 523 specimens, 58.3% (n = 305) were from patients younger than 2 years. The BD Veritor RSV POC assay sensitivity and specificity are 81.6% (146/179) and 99.1% (341/344), respectively. When compared with RT-PCR, the BD Veritor RSV POC assay false positive was 0.9% (3/344, with a 95% confidence interval of 0.3%-2.5%) and the false negative was 18.4% (33/179, with a 95% confidence interval of 13.4%-24.5%). The BD Veritor RSV POC assay identified more true positive specimens (n = 146) than viral cell culture (n = 134 positive specimens). CONCLUSIONS: In 8 participating primary care pediatric offices with 523 evaluable subjects, POC BD Veritor RSV tests performed better than viral cell culture results when RT-PCR was the reference standard.