Summary Of Ancestry In A Drop Of Blood Video
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Trials volume 22Article number: Cite this article. Metrics details.
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The secondary objectives include evaluating the efficacy after at least one dose of the vaccine against RT-PCR confirmed symptomatic COVID cases; the efficacy of two doses of the vaccine on the rates of Boood and death; the safety of the vaccine including adverse reactions up to one year after the 2 nd dose of vaccination; and the immunogenicity of the vaccine and its duration up to days. This is a phase III, randomized, double-blind, placebo-controlled case driven clinical trial to assess the efficacy and safety of the vaccine.
The study is planned to Ancesrty carried out within two separate cohorts in voluntary participants aged between years old. Summary Of Ancestry In A Drop Of Blood first cohort includes healthcare professionals actively this web page in healthcare units, who are assumed to have higher risk of acquiring COVID, and the second cohort includes other immunocompetent subjects in the same age group, who are at a regular risk for COVID disease.
In Cohort 1, healthcare professionals will be randomized to receive two intramuscular doses of investigational product or the placebo in a ratio and they will be monitored for 12 months by active surveillance of COVID In Cohort 2, immunocompetent subjects will be randomized to receive vaccine or the placebo in a ratio. Healthcare professionals of both genders, including medical doctors, nurses, cleaners, hospital technicians, and administrative personnel who work in any department of a healthcare unit and immunocompetent individuals of both genders are included. Pregnant confirmed by positive beta-hCG test and breastfeeding women as well as those intending to become pregnant within three months after vaccination are Bpood.
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Other exclusion criteria include history of COVID test positivity PCR or immunoglobulin go here resultsany form of immunosuppressive therapy including corticosteroids within 6 months, history of bleeding disorders, asplenia, and administration of any form of immunoglobulins or blood products within 3 months. Exclusion criteria for the second dose include any serious adverse events related with the vaccine, anaphylaxis or hypersensitivity after vaccination, or any confirmed or suspected autoimmune or immunosuppressive disease including HIV infection. Participants are only included after signing the voluntary informed consent form, ensuring cooperation in visits, undergoing screening for evaluation, and conforming to all the inclusion and exclusion criteria.
All clinical sites are located in Turkey. It is a preparation made from a novel coronavirus strain CZ02 grown in the kidney cell cultures Vero Cell of the African green monkey and contains inactivated SARS-CoV-2 virus, aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride.
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A dose of 0. The placebo contains aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride 0. Scheduled visits and additional unscheduled weekly visits will be performed for the first 13 weeks and neutralizing antibody test, IgG test, T-Cell activation test, pregnancy test, and RT-PCR tests along with total antibody test Skmmary be performed. Adverse events and serious adverse events during the follow-up will be recorded on diary cards.
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Diary cards will collect information on the timing and severity of COVID symptoms and solicited adverse events recorded by the subjects during one-year follow-up period. All serious adverse events will be managed and necessary treatment will be ensured according to the local regulations. All serious adverse events following vaccination will be reported to the ethics committee, the Ministry of Health, and the study sponsor within 24 hours of detection.
The primary safety endpoint is the severity and frequency of local and systemic adverse reactions during the period of one week after vaccination. The IWRS system customizes the randomization algorithm.]
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