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Module 2 Safety & Mobility
Module 2 Safety and Mobility
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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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IMAGES
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COMMENTS
Module 2 - Safety and Mobility Assignment. General Directions: A. Assignment is 50 marks as assigned. B. The assignment will count for 30% of your final mark in Module 2.
Module 2 - Safety and Mobility Assignment General Directions: A. Assignment is 50 marks as assigned. B. The assignment will count for 30% of your final mark in Module 2. Name: Kiru Date: August 28 th 2021 HOME INSPECTION . 1. Choose a home (apartment, condo) to inspect for safety hazards.
Module 2 - Safety and Mobility Assignment General Directions: A. Assignment is 50 marks as assigned. B. The assignment will count for 30% of your final mark in Module 2. ... Safety and Mobility 4 | 7 Room/area Hazard(s) Target age affected Safety measures already in place Suggested changes to improve safety Example: Living room Cracked glass ...
1. Choose a home (apartment, condo) to inspect for safety hazards. It can be your own home, but ensure there is enough to inspect to make this assignment a worthwhile learning experience for you. Include the following in your inspection: Approximate age of the home: 67 years old Style of the home (two-story, one floor condo, etc.): 3-story stacked townhouse Number of persons living in the home ...
One of the priorities of a PSW, protect clients, visitors, yourself and co-workers. Accident Risk Factors. Awareness, vision/hearing, taste smell, and touch, mobility challenges, effects of medication, Age - both young and old are at risk etc. (chp: 14, 15, 19, 20, 32) Learn with flashcards, games, and more — for free.
Accounting document from Seneca College, 8 pages, Module 2 - Safety and Mobility Assignment General Directions: A. Assignment is 50 marks as assigned. B. The assignment will count for 30% of your final mark in Module 2. Name: Date: 2023-3-19 ©N ACC 2 0 1 5 V6 Section IV. Module 2. Safety and Mobility 1 |
module 2 - safety and mobility assignment Personal support worker HOME INSPECTION 1.Choose a home (apartment, condo) to inspect for safety hazards. It can be your ownhome, but ensure there is enough to inspect to make this assignment a worthwhilelearning experience for you. Include the following in your inspection: Approximate age of the.
Is the loss of muscle size, strength, and function (muscle atrophy) that results from immobility and inactivity. Bed rest. Ordered by the Physician to reduce physical activity, reduce pain, encourage rest, regain strength, promote healing. Strict bed rest. Client must remain in bed at all times.
View IV-3 Assignment - Module 2 Safety & Mobility.pdf from ME MISC at York University. Module 2 - Safety and Mobility Assignment General Directions: A. Assignment is 50 marks as assigned. B. The
Module 2. Safety and Mobility. This module deals with aspects of safety as they relate to both the consumer/client and the worker. One of the fundamental activities of the Personal Support Worker is assisting the consumer/client with routine activities of living. It is essential that the PSW provide assistance in a manner that is effective ...
This module explores the patient's ability to maintain optimal wellness for functioning through environmental safety methods, preservation of skin integrity, mobility, and hazards related to. immobility and elimination. The student will demonstrate nursing knowledge and actions required to facilitate wellness and protect the patient from ...
24. A workplace hazardous material information system. 26. microorganization need all of the following to grow and live except. Glove should be worm. Contact with blood. Study with Quizlet and memorize flashcards containing terms like B. Addiction, B. Prone position, C. Muscles of the legs and more.
General Directions: Module 2 -Safety and Mobility Assignment A. Assignment is 50 marks as assigned. 8. The assignment will count for 30% of your final mark in Module 2. ©NACC 2017 V . 4 Section IV . Module 2. Safety and Mobility 1 I 7
Biology document from Centennial College, 10 pages, Module 2 - Safety and Mobility Assignment General Directions: A. Assignment is 50 marks as assigned. B. The assignment will count for 30% of your final mark in Module 2. Name: Date: May 25, 2023 ©NACC2015V6 Section IV. Module 2. Safety and Mobility 1 | 10
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.
ILO World Day of Safety and Health at Work 2004, Moscow . Created Date: 4/15/2004 2:50:50 PM ...
ILO World Day of Safety and Health at Work 2004, Moscow . Created Date: 4/15/2004 5:13:02 PM ...
Module 2 - Safety and Mobility Assignment. General Directions: A. Assignment is 50 marks as assigned. B. The assignment will count for 30% of your final mark in Module 2. Name: CHRISLINEDWIN_____ Date: 14 N0V 2023 ...
View Safety Assignment .docx from NURS 3323 at Carleton University. Module 2 - Safety and Mobility Assignment General Directions: A. Assignment is 50 marks as assigned. ... Module 2 - Safety and Mobility Assignment General Directions: A. Assignment is 50 marks as assigned. B. The assignment will count for 30% of your final mark in Module 2.
This video from AnalystZone walks you through the concept, principles and dos' and don'ts about using MoSCoW technique. A popular business/systems analysis t...