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NCT ID: NCT05044195 Not yet recruiting - Influenza, Human Clinical Trials

A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age

Start date: October 1, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study is a randomized, observer-blind study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age. The aim of the study is to demonstrate a noninferior immune response for aQIV versus the comparator vaccine for all four vaccine strains, and a superior immune response for at least two of the four vaccine strains.

NCT ID: NCT04967508 Recruiting - Psoriasis Clinical Trials

A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis

Start date: July 6, 2021
Phase: Phase 3
Study type: Interventional

This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.

NCT ID: NCT04947748 Recruiting - Acute Appendicitis Clinical Trials

Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous is a prospective randomized controlled trial comparing 24 hour intravenous antibacterial therapy to 24 hour oral antibacterial therapy after surgery in complicated appendicitis.

NCT ID: NCT04939636 Recruiting - Clinical trials for Vitamin D Deficiency

Vitamin D Supplementation in Estonian Conscripts

Start date: July 19, 2021
Phase: N/A
Study type: Interventional

A longitudinal, double-blinded, randomized, trial, with a 10 month follow-up period will be conducted between July 2021 to May 2022

NCT ID: NCT04934072 Recruiting - Clinical trials for Postmenopausal Osteoporosis

A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis

Start date: July 5, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO). Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks. At the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks. Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period.

NCT ID: NCT04930042 Recruiting - Psoriasis Clinical Trials

Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis

Start date: June 3, 2021
Phase: Phase 3
Study type: Interventional

Safety and Efficacy study of AVT04 (Alvotech Biosimilar to Ustekinumab), in patients with moderate to severe plaque psoriasis

NCT ID: NCT04916574 Completed - Covid19 Clinical Trials

Clinical Trial of BioBlock COVID-19 Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum

Start date: March 20, 2021
Phase: N/A
Study type: Interventional

For an antiviral agent to act as an effective biological barrier on nasal mucosal surface, the formulation preferably has to be maintained on the site of action for several hours, and the nasal spray dispenser can be utilized for administering the solution to the upper respiratory tract. A "first-in-man" clinical study of the nasal spray containing anti-SARS-CoV-2 antibodies derived from bovine colostrum was conducted. The study on healthy volunteers was undertaken to evaluate how long the bovine antibodies would be maintained on the nasopharyngeal surface after administration of nasal spray. In addition, the study enabled to determine which of the two concentrations of antibodies should be used in the final nasal-spray formulation. The volunteers were followed up for 4h after administration of antibody spray and sampling was done at different time-points during this period. The concentration of antibodies from patient samples was measured using ELISA analysis. In addition, as this was a "first-in-man" study any adverse events following the administration of spray were also monitored.

NCT ID: NCT04908683 Recruiting - Clinical trials for Respiratory Syncytial Viruses

A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

EVERGREEN
Start date: July 21, 2021
Phase: Phase 3
Study type: Interventional

The study will enroll up to 23000 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.

NCT ID: NCT04882098 Recruiting - Clinical trials for Arthritis, Psoriatic

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

APEX
Start date: June 17, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

NCT ID: NCT04867499 Recruiting - Clinical trials for Acute Mesenteric Ischemia

Epidemiology of Acute Mesenteric Ischemia

Start date: April 21, 2021
Phase:
Study type: Observational

Retrospective population-based study on epidemiology of acute mesenteric ischemia in Estonia Study objective is to describe epidemiologic features in adult patients with acute mesenteric ischemia during years 2016-2020. Patients from all hospitals in Estonia are included.