Publication date: Available online 1 November 2015
Source:Vaccine
Author(s): Ruvim Izikson, David J. Leffell, S. Allan Bock, Peter A. Patriarca, Penny Post, Lisa M. Dunkle, Manon M.J. Cox
BackgroundThe safety and tolerability of Flublok®, a purified recombinant hemagglutinin seasonal influenza vaccine, was compared to AFLURIA® in a randomized, blinded clinical trial in adults ≥50 years of age with attention to hypersensitivity reactions.MethodsThis blinded, randomized trial of healthy adults ≥50 years of age compared safety of Flublok vs. AFLURIA with respect to pre-specified possible hypersensitivity: "rash," "urticaria," "swelling" and "non-dependent edema;" solicited reactogenicity and unsolicited adverse events. Subject-reported outcomes were collected for 30 days after vaccination. All adverse event terms were reviewed by physicians blinded to vaccine group, who added other terms possibly reflecting hypersensitivity. Case records of subjects with possible hypersensitivity were adjudicated by independent experts blinded to treatment assignment to identify likely hypersensitivity reactions. Non-inferiority of the incidence of hypersensitivity in the two vaccine groups was pre-defined as an absolute difference with an upper bound of 2-sided 95% confidence limits ≤0.015.ResultsA total of 2640 subjects were enrolled, evenly split in age cohorts of 50–64 and ≥65 years. Fifty-two subjects reported at least one term possibly representing hypersensitivity, with a slight imbalance of 31 on Flublok and 21 on AFLURIA. The adjudicators determined that six and four subjects on Flublok and AFLURIA, respectively, likely met clinical criteria for hypersensitivity, yielding a difference in incidence between the two vaccine groups of 0.15% (upper bound of 2-sided 95% CI=0.9%). Reactogenicity and overall adverse event profiles were similar across both vaccines.ConclusionsFlublok was non-inferior to AFLURIA in adults ≥50 years of age with respect to expert-adjudicated events of likely hypersensitivity during 30 days following vaccination (Sponsored by Protein Sciences Corporation; ClinicalTrials.gov number NCT01825200).
from #Medicine via ola Kala on Inoreader http://ift.tt/1LLk4Of
via IFTTT
Αρχειοθήκη ιστολογίου
-
►
2023
(138)
- ► Φεβρουαρίου (74)
- ► Ιανουαρίου (64)
-
►
2022
(849)
- ► Δεκεμβρίου (61)
- ► Σεπτεμβρίου (74)
- ► Φεβρουαρίου (65)
-
►
2021
(2936)
- ► Δεκεμβρίου (59)
- ► Σεπτεμβρίου (180)
- ► Φεβρουαρίου (325)
-
►
2020
(1624)
- ► Δεκεμβρίου (293)
- ► Σεπτεμβρίου (234)
- ► Φεβρουαρίου (28)
-
►
2019
(13362)
- ► Δεκεμβρίου (19)
- ► Σεπτεμβρίου (54)
- ► Φεβρουαρίου (5586)
- ► Ιανουαρίου (5696)
-
►
2018
(66471)
- ► Δεκεμβρίου (5242)
- ► Σεπτεμβρίου (5478)
- ► Φεβρουαρίου (4835)
- ► Ιανουαρίου (5592)
-
►
2017
(44259)
- ► Δεκεμβρίου (5110)
- ► Σεπτεμβρίου (5105)
-
►
2016
(7467)
- ► Δεκεμβρίου (514)
- ► Σεπτεμβρίου (1038)
- ► Φεβρουαρίου (793)
-
▼
2015
(2119)
- ► Δεκεμβρίου (940)
-
▼
Νοεμβρίου
(765)
-
▼
Νοε 01
(31)
- Therapeutic effects of inorganic nitrate and nitri...
- Intake of Meals Containing High Levels of Carbohyd...
- Production of high titer attenuated poliovirus str...
- Pediatric provider vaccine hesitancy: An under-rec...
- Non-thermal plasma for inactivated-vaccine prepara...
- Assessment of the enhancement of PLGA nanoparticle...
- Intranasal immunisation with recombinant adenoviru...
- Randomized comparison of the safety of Flublok® ve...
- Incidence of invasive pneumococcal disease in 5–15...
- The bm12 Inducible Model of Systemic Lupus Erythem...
- Strength training, but not endurance training, red...
- Factors to consider in identifying critical points...
- Nanoparticle Probes for Structural and Functional ...
- Reducing sitting time after stroke. A Phase II saf...
- A Cross-Sectional Examination of the Associations ...
- Isoflurane Damages the Developing Brain of Mice an...
- Prognostic Significance of the Tumor-Stroma Ratio ...
- Effectiveness and Safety of Manufactured Chinese H...
- The Combination of Resveratrol and Quercetin Atten...
- MR Prediction of Liver Function and Pathology Usin...
- Magnetic Resonance Imaging as a Biomarker for Rena...
- Endogenous Ouabain: An Old Cardiotonic Steroid as ...
- Novel Sensor-Enabled Ex Vivo Bioreactor: A New App...
- Coevolution between Cancer Activities and Food Str...
- Upconversion nanosensor for sensitive fluorescence...
- Metabolomic profile related to cardiovascular dise...
- Synthesis and Biological Profiling of 6- or 7-(Het...
- Synthesis and Evaluation of 3-Hydroxy-3-phenylprop...
- Big Data and Network Biology 2015
- Synergistic Effects of BMP9 and miR-548d-5p on Pro...
- Interoceptive awareness in patients with functiona...
-
▼
Νοε 01
(31)
Αναζήτηση αυτού του ιστολογίου
Κυριακή 1 Νοεμβρίου 2015
Randomized comparison of the safety of Flublok® versus licensed inactivated influenza vaccine in healthy, medically stable adults ≥50 years of age
Εγγραφή σε:
Σχόλια ανάρτησης (Atom)
-
Αλέξανδρος Γ. Σφακιανάκης Medicine by Alexandros G. Sfakianakis,Anapafseos 5 Agios Nikolaos 72100 Crete Greece,00302841026182,0030693260717...
-
heory of COVID-19 pathogenesis Publication date: November 2020Source: Medical Hypotheses, Volume 144Author(s): Yuichiro J. Suzuki ScienceD...
-
https://ift.tt/2MQ8Ai8
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου
Σημείωση: Μόνο ένα μέλος αυτού του ιστολογίου μπορεί να αναρτήσει σχόλιο.