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Study record managers: refer to the Data Element Definitions if submitting registration or results information.
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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).
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- Written Informed consent of a volunteer (14 years and older) and one of the parents to participate in a clinical trial.
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- A case of established COVID-19 disease confirmed by PCR and/or ELISA in the last 6 months.
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- 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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Russia's Nuclear Deterrent Command Center Imperiled by Winter Freeze—Report
A Russian nuclear deterrent command center in Moscow has been imperiled by power outages that have impacted more than one-quarter of the region's cities amid freezing temperatures, a Russian Telegram channel has reported.
The VChK-OGPU outlet, which purports to have inside information from Russian security forces, reported that the 820th Main Center for Missile Attack Warnings—part of the Russian Space Forces, a branch of the country's Aerospace Forces—near Solnechnogorsk in Moscow is without power.
It serves as the space forces early warning network against potential ballistic missile attacks.
The development comes as Russians are reported to be suffering from power outages in their homes in the Moscow region caused by technical issues at plants amid subzero temperatures.
On January 4, a heating main burst at the Klimovsk Specialized Ammunition Plant in the town of Podolsk, which is about 30 miles south of central Moscow. Since then, tens of thousands of Russians are reported to have no heating in their homes.
Affected areas include the cities of Khimki, Balashikha, Lobnya, Lyubertsy, Podolsk, Chekhov and Naro-Fominsk, a map published by a Russian Telegram channel and shared on other social media sites shows.
Other Russian media outlets reported that in Moscow, residents of Balashikha, Elektrostal, Solnechnogorsk, Dmitrov, Domodedovo, Troitsk, Taldom, Orekhovo-Zuyevo, Krasnogorsk, Pushkino, Ramenskoye, Voskresensk, Losino-Petrovsky and Selyatino are also without power.
The Telegram channel said that at the 820th Main Center for Missile Attack Warnings, "the crew...is on duty around the clock."
"It is here that the decision on a retaliatory nuclear strike is executed," the channel said.
Newsweek could not independently verify the report and has reached out to the Russian Defense Ministry by email for comment.
Power outages have also been reported in Russia's second-largest city, St. Petersburg, in the country's western Voronezh region, in the southwest city of Volgograd, and in Rostov, which borders Ukraine, a country that Russia has been at war with since February 24, 2022.
On Sunday, two shopping malls in St. Petersburg were forced to close because of problems with light and heating, reported local news outlet 78.ru. Hundreds of other homes in the city have had no electricity, water or heating for days amid temperatures of -25 C (-13 F).
Russian authorities have also been forced to compensate passengers of a train that ran from Samara to St. Petersburg (a 20-hour journey) without heating during -30 C (-22 F) temperatures. Videos circulating on social media showed carriage windows frozen over. A passenger also said the toilet didn't work during the trip because of frozen pipes.
Do you have a tip on a world news story that Newsweek should be covering? Do you have a question about the Russia-Ukraine war? Let us know via [email protected].
Related Articles
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- Serbian Mercenary Turns on Russian Leaders: 'They Treat Us Like Cattle'
- Winter Freeze Threats Come Back To Bite Russia As Power Outages Spread
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The Learning Journey: Puzzle Doubles - Giant ABC & 123 Train Floor Puzzles - Large Floor Puzzles For Kids Ages 3-5 - Award Winning Toys Visit the The Learning Journey Store 4.7 4.7 out of 5 stars 861 ratings
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The bright illustrations encourage parent-child conversation. Each 100-piece puzzle measures a giant 3ftx2ft ! Ages 3+ years. Number of Pieces: 100. Suggested Age: 3 Years and Up. Assembled Dimensions: 24.0 inches (W) Assembled Length: 36.0 inches. Educational Focus: Problem Solving. Material: Plastic.
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After assembling the 100-piece puzzle, turn off the lights and be amazed as it glows in the dark. Your child's imagination will run wild with all these friendly lovable monster creatures! Each Glow in the Dark puzzle measures 3' X 2'! Ages 3+ years. Suggested Age: 3 Years and Up. Assembled Dimensions: 24.25 inches (W)
Learning about dinosaurs has never been so much fun. Expand your knowledge of dinosaurs with this 100-piece Puzzle Double! After you put the puzzle together, turn off the lights and the puzzle glows in the dark! Additionally turn the puzzle over and you have a colouring activity. Each 100-piece puzzle measures a giant 92 cm x 61! Ages 3+ years.
Amazon.com: The Learning Journey Puzzle Doubles - Find It! 123 - STEM Preschool Toys & Gifts for Boys & Girls Ages 3 and Up, 24" H x 36" W x 0.08" D (695180) , ... Puzzles To see product details, add this item to your cart. You can always remove it later. FREE Returns . Return this item for free ...
Beginning in 1957 almost every foreign literary, musical or creative figure to journey to Moscow made the pilgrimage to Peredelkino. The pilgrimage was halted only for a few months after the enormous agitation over "Doctor Zhivago." There was evidence that Premier Khrushchev himself had intervened to end the attacks on Mr. Pasternak.
Double-blind, Placebo-controlled, Randomized Study of Tolerability, Safety and Immunogenicity of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", of Children at the Age of 12-17 Years Inclusive" ...
The bright illustrations of friendly faces, pets and charming landscapes encourage parent-child conversation. Each puzzle has over 60 pieces and measures a giant 3' x 2'! Ages 3+ years. Suggested Age: 3 Years and Up. Assembled Dimensions: .06 inches (W) Assembled Length: 40.5 inches. Material: Plastic. TCIN: 81300534.
Russian authorities have also been forced to compensate passengers of a train that ran from Samara to St. Petersburg (a 20-hour journey) without heating during -30 C (-22 F) temperatures.
Creative Child 2021 Puzzle of the Year Award . Puzzle Doubles! Puzzle Doubles Glow In The Dark Fantasy is the proud recipient of the Creative Child Puzzle of the Year award! The Learning Journey continues to provide parents and teachers with award-winning tools to help children develop the skillsets needed to succeed in school.
Central PPK operates a train from Ploschad Tryokh Vokzalov to Fryazevo 4 times a day. Tickets cost RUB 120 - RUB 170 and the journey takes 44 min. Train operators. Central PPK. Other operators. BlaBlaCar. Taxi from Moscow Central Bus Station to Elektrostal.
Designed to strengthen problem-solving and encourage early language and learning skills, children will love the fun dinosaur theme. Double the puzzle fun as the scene changes when over 30% of the puzzle glows in the dark! Specs: 100 glow in the dark puzzle pieces made of thick, durable cardboard construction. Completed puzzle measures 36" x ...
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Double the puzzle fun as the scene changes when over 30% of the puzzle glows in the dark! Specs: 100 glow in the dark puzzle pieces made of thick, durable cardboard construction. Completed puzzle measures 36" x 24". Educational Benefits - Builds tactile, motor, thinking and learning skills. Strengthens color, shape and object recognition.