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Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 of Children at the Age of 12-17 Years Inclusive"
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Recruitment of volunteers will be competitive. A maximum of 450 children aged 12 to 17 years inclusive will be screened in the study, of which it is planned to include and randomize 300 children who meet the criteria for inclusion in the study and do not have non-inclusion criteria, data on which will be used for subsequent safety and immunogenicity analysis.
Group 1 - 150 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days intramuscularly.
Group 2 - 150 volunteers who will receive a placebo twice with an interval of 21 days intramuscularly.
In case of withdrawal of volunteers from the study, their replacement is not provided.
Inclusion Criteria:
- Volunteers must meet the following inclusion criteria:
Type of participants • Healthy volunteers.
Age at the time of signing the Informed Consent
• from 12 to 17 years inclusive (12 years 0 months 0 days - 17 years 11 months 30 days).
Paul • Male or female.
Reproductive characteristics
- For girls with a history of mensis - a negative pregnancy test and consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Girls should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals).
- For young men capable of conception - consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Young men and their sexual partners should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals).
Research procedures
- Written Informed consent of a volunteer (14 years and older) and one of the parents to participate in a clinical trial.
- Volunteers who are able to fulfill Protocol requirements (i.e. answer phone calls, fill out a Self-observation Diary, come to control visits).
Non-inclusion criteria:
- Volunteers cannot be included in the study if any of the following criteria are present:
SARS-CoV-2 infection
- A case of established COVID-19 disease confirmed by PCR and/or ELISA in the last 6 months.
- History of contacts with confirmed or suspected cases of SARS-CoV-2 infection within 14 days prior to vaccination.
- Positive IgM or IgG to SARS-CoV-2 detected on Screening.
- Positive PCR test for SARS-CoV-2 at Screening / before vaccination.
Diseases or medical conditions
- Serious post-vaccination reaction (temperature above 40 C, hyperemia or edema more than 8 cm in diameter) or complication (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions, accompanied or not accompanied by a feverish state) to any previous vaccination.
- Burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness in the anamnesis, hypersensitivity or allergic reactions to the introduction of any vaccines in the anamnesis, known allergic reactions to vaccine components, etc.).
- Guillain-Barre syndrome (acute polyradiculitis) in the anamnesis.
- The axillary temperature at the time of vaccination is more than 37.0 ° C.
- Positive blood test for HIV, syphilis, hepatitis B/C.
- Acute infectious diseases (recovery earl
Exclusion Criteria:
- • Withdrawal of Informed consent by a volunteer and/or a parent of a volunteer;
- The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol;
- Availability of inclusion/non-inclusion criteria before vaccination;
- Any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study;
- The established fact of pregnancy before the second vaccination;
- Taking unauthorized medications (see section 6.2);
- The volunteer's incompetence with the study procedures;
- The volunteer refuses to cooperate or is undisciplined (for example, failure to attend a scheduled visit without warning the researcher and/or loss of communication with the volunteer), or dropped out of observation;
- For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as in case of gross violations of the protocol that may affect the results of the study.
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- Victor Mukhin
Victor M. Mukhin was born in 1946 in the town of Orsk, Russia. In 1970 he graduated the Technological Institute in Leningrad. Victor M. Mukhin was directed to work to the scientific-industrial organization "Neorganika" (Elektrostal, Moscow region) where he is working during 47 years, at present as the head of the laboratory of carbon sorbents. Victor M. Mukhin defended a Ph. D. thesis and a doctoral thesis at the Mendeleev University of Chemical Technology of Russia (in 1979 and 1997 accordingly). Professor of Mendeleev University of Chemical Technology of Russia. Scientific interests: production, investigation and application of active carbons, technological and ecological carbon-adsorptive processes, environmental protection, production of ecologically clean food.
Title : Active carbons as nanoporous materials for solving of environmental problems
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Shadow Health Delegation. Get a hint. Bedside Shift Report. Holly: Mr. Liu, this is your new nurse. They'll be taking over for me. Samuel: Hello. Nice to meet you. I'll be checking in with you every hour or so. Holly: All right, Mr. Liu, I'm going to hand you off to your new nurse using a Bedside Shift Report.
Bedside Shift Report, Team Delegation, Communication, Prioritizing Individual Patient Needs, Prioritizing Delivery of Care ... Shadow Health Leadership - Assignment 5 Change Management and Patient Advocacy. 19 terms. ayeringto. Preview. Project Management. 29 terms. tylertblizzard. Preview.
Shadow Health Assignment 3: Conflict Management. 45 terms. maddie_braud. Preview. Shadow Health Leadership - Assignment 5 Change Management and Patient Advocacy. 19 terms. ... Prioritizing delivery of care-0800. Samuel Liu. Prioritizing delivery of care-0900. Anita Douglas. About us. About Quizlet; How Quizlet works; Careers; Advertise with us;
ljkolj 9:20 am assignment conflict management completed shadow health in the coming weeks, shadow health is ending our support of macos 10.14 (mojave). in order ... Assignment 3: Conflict Management Results | Completed Healthcare Participant IV - Worcester - Fall 2021, NUR 522 ... Prioritizing Delivery of Care. Student Survey.
Shadow Health® │ Digital Clinical Experiences™ from Elsevier Conflict Management (prioritizing care) shadow digital clinical from elsevier 6:19 am assignment ... Prioritizing Delivery of Care Score: 18 out of 25 Time: 0800 Description of Activity ... Assignment 3: Conflict Management Results | Completed. BSN Level 3: Leadership Cases ...
Assignment 3: Conflict Management Results | Turned In Leadership RNSG 2560 Fall 2023 Return to Assignment (/assignments/872842/) Prioritizing Delivery of Care Score: 25 out of 25 Time: 0800 Description of Activity Prioritize the delivery of care between five patients. Student Responses Samuel Liu
Prioritizing Delivery of Care Score: 25 out of 25 Time: 0800 Description of Activity Prioritize the delivery of care between five patients. Student Responses Samuel Liu Mr. Liu needs to have his chest tube assessed every hour. The rest of the patients are stabl Model Response When you have a number of patients in your care, it is important to identify which patients needs you should be ...
Sales Tax Notification: Elsevier Inc. DBA Shadow Health charges applicable sales tax as required by state and local regulations. Prioritizing Delivery of Care Score: 25 out of 25 Time: 0800 Description of Activity Prioritize the delivery of care between five patients.
Unformatted text preview: Time: 0900 Description of Activity Prioritize care between five patients Student Responses Anita Douglas Upcoming PT Model Response Patients with upcoming procedures or activities should be prioritized in order to be ready for all scheduled events. In order to coordinate effectively with other healthcare professionals, you must have your patients prepared in a timely ...
Assignment 5: Change Management and Patient Advocacy Results | Turned In Leadership RNSG 2560 Fall 2023 Return to Assignment (/assignments/872844/) Prioritizing Delivery of Care Score: 35 out of 35 Time: 0900 Description of Activity Prioritize care between multiple patients. Student Responses Omar Haddad
Arun Patel When prioritizing patients, it is important to ask yourself if not prioritizing a patient could have a negative impact on their well-being. While all patient needs will be met in a timely manner, any patients with immediate requirements should be attended to first in order to maximize efficient and positive delivery of care.
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Recruitment of volunteers will be competitive. A maximum of 450 children aged 12 to 17 years inclusive will be screened in the study, of which it is planned to include and randomize 300 children who meet the criteria for inclusion in the study and do not have non-inclusion criteria, data on which will be used for subsequent safety and immunogenicity analysis.
View Assignment 4 - Prioritizing Delivery of Care.pdf from NRSG 4996 at Northeastern University. Assignment 4: Ethics | Completed | Shadow Health 3/18/21, 5:54 PM If you are are experiencing audio
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Shadow Health Mod 3 - conflict management sim modules assignment conflict management results turned in leadership rnsg 2560 fall 2023 return to assignment your. ... Prioritizing Delivery OF CARE; Med Scenario #4 - Carl Shapiro - Lippencott v Sim; 23-10-03 Transcript - Unguided Pharmacology Pt - Edward Carter;
Thank you for helping us to improve your Shadow Health experience! Prioritizing Delivery of Care Score: 20 out of 20 Time: 1335 Description of Activity Prioritize the delivery of care between Mr. Patel, Mr. Haddad, and Mr. Liu. Student Responses Omar Haddad Upcoming Procedure Model Response Patients with upcoming procedures or activities should ...
Prioritize delivery of care between multiple patients? ... Shadow Health Assignment 3: Conflict Management. 45 terms. maddie_braud. Preview. bug lab practi cum study guide. 64 terms. emilyrothe. Preview. Chapter 2. 54 terms. builditbaby. Preview. types of support F. 6 terms. b0408hs.
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