CLINICAL STUDY PROTOCOL - Moderna
Main Rationale for the Amendment: The main purpose of this amendment is to make changes to the protocol in response to feedback from CBER. The summary of changes table provided here describes the major changes made in Amendment 3 relative to Amendment 2, including the sections modified and the corresponding rationales. Minor
Download CLINICAL STUDY PROTOCOL - Moderna
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
Advertisement
Documents from same domain
Vaccination Provider Fact Sheet | EUA | Moderna COVID-19 ...
www.modernatx.comPrimary Series: Each primary series dose of the Moderna COVID-19 Vaccine is 0.5 mL. The Moderna COVID-19 Vaccine is administered as a primary series of two doses (0.5 mL each) ... See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have . Revised: Dec/9/2021 2
COVID-19 Vaccine (mRNA-1273) - Moderna
www.modernatx.comNov 16, 2020 · Pediatric respiratory syncytial virus (RSV) vaccine Future respiratory combo Worldwide mRNA-1189 Epstein-Barr virus (EBV) vaccine Worldwide mRNA-1851 Influenza H7N9vaccine ... Presentation of older adults Phase 1 data October 22, 2020 Phase 3 COVE study completed enrollment of 30,000 participants Sept 29, 2020 Publication of older adults …
Virus, Adults, Respiratory, Older, Syncytial, Older adults, Respiratory syncytial virus
Storage Handling - Moderna
www.modernatx.comStorage and Handling The information in this Fact Sheet supersedes the information on the vial and carton labels. During storage, minimize exposure to room light. The Moderna COVID-19 Vaccine multiple-dose vials are stored frozen between -50º to -15ºC (-58º to 5ºF). Store in the original carton to protect from light.
WHITE PAPER mRNA Vaccines - Moderna
www.modernatx.comsyringe Investment decisions in production facility (3-5yr lead time) Standardized (mg scale) Standardized (kg scale) Standardized multiproduct facility (kg scale) mRNA vaccine DNA vaccine: Bespoke facility ($100mm-$1bn) (tonne scale) Specialized delivery system Standard needle &
US00000010898574B220210126
www.modernatx.comTitle: US00000010898574B220210126 Subject: 00780001 Created Date: 20210106010406Z
IMPORTANT PRESCRIBING INFORMATION Booster Dose …
www.modernatx.comreport vaccine administration errors to the Vaccine Adverse Event Reporting System (VAERS). See the Fact Sheet for Vaccination Providers for reporting instructions. Additional Resources To access the most recent Moderna COVID-19 Vaccine Fact Sheets, please scan the QR code or
Administration, Vaccine, Errors, Vaccine administration errors
Vaccine Recipient Fact Sheet | EUA | Moderna COVID-19 …
www.modernatx.comEMERGENCY USE AUTHORIZATION (EUA) OF THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) IN INDIVIDUALS 18 YEARS OF AGE AND OLDER You are being offered the Moderna COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to …
Reimbursement for the Moderna COVID-19 Vaccine
www.modernatx.comcharge for administration. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients).
Administration, Vaccine, Covid, Covid 19 vaccine, Covid 19 vaccine administration
Moderna COVID-19 Vaccine EUA Letter of Authorization
www.modernatx.comJan 31, 2022 · vaccine in individuals 18 years of age or older who have undergone solid organ transplantation, or individuals 18 years of age or older who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise, FDA reviewed safety and effectiveness data reported in two manuscripts on solid organ transplant recipients.
Solid, Argon, Transplantation, Solid organ, Solid organ transplantation
Hoja informativa para receptores de la vacuna | EUA ...
www.modernatx.comLa vacuna contra la COVID-19 de Moderna es una vacuna no aprobada. En ensayos clínicos, aproximadamente 15,400 personas de 18 años en adelante han recibido al menos 1 dosis de la vacuna contra la COVID-19 de Moderna. Millones de personas han recibido la vacuna en virtud
Related documents
MC No 21 s 2004 (Amendment relative to the Guidelines on ...
www.csc.gov.phTitle: MC No 21 s 2004 (Amendment relative to the Guidelines on Study Leave).tif Author: shiela Created Date: 7/21/2008 3:52:39 PM
Guidelines, Relative, Amendment, Amendment relative to the guidelines
Excreta-related infections and the role of sanitation in ...
www.who.intdimensions and relative importance of sanitation measures, and discusses technical options for the containment and treatment of excreta. It highlights the need to consider water-related guidelines and standards in terms of the ‘greater picture’, utilising an integrated approach rather than proceeding on a case by case basis.
Doc 9303 Machine Readable Travel Documents
www.icao.int• Humidity. The MRTD shall be machine readable at a relative air humidity ranging from 5 per cent to 95 per cent, with a maximum wet bulb temperature of 25°C (77°F), as specified in [ISO/IEC 7810]. The MRTD should not lose its reliability after being stored at, or exposed to, a relative air humidity ranging
Document, Machine, Travel, Relative, Readable, Machine readable travel documents
Annex 5 Guidelines for stability testing of pharmaceutical ...
www.paho.org1RH = relative humidity. Table 3 Mean climatic conditions: ... Amendment from Draft of the 37th Report of The WHO Expert Committee on Specifications for Pharmaceutical Preparations Geneva, 22-26 October 2001 11.1 WHO guidelines for stability testing of pharmaceutical products containing well-
EIB Project Carbon Footprint Methodologies
www.eib.orgAmendment Description . Version 1 : ... Relative emissions can be either positive or negativesed on whether there is an , ba ... The methodologies set out below are based upon the internationally recognised IPCC Guidelines, the WRI GHG Protocol and the IFI’s Harmonised Approach to GHG Accounting. In the absence of project
Guideline: Perineal care - Queensland Health
www.health.qld.gov.auFor further information, contact Queensland Clinical Guidelines, RBWH Post Office, Herston Qld 4029, email . Guidelines@health.qld.gov.au, For permissions beyond the scope of this licence, contact: Intellectual Property Officer, Queensland Health, GPO Box 48, Brisbane Qld 4001, email ip_officer@health.qld.gov.au, phone (07) 3234 1479.
[TO BE PUBLISHED IN GAZETTE OF INDIA, EXTRAORDINARY, …
www.mca.gov.in#Relative here means relative as defined in the Companies Act, 2013. *Promoter here means promoter as defined in the Companies Act, 2013. (ii) Where the Company has revalued its Property, Plant and Equipment, the company shall disclose as to whether the revaluation is based on the valuation by a registered valuer as
REVISED GUIDELINES FOR FORMAL SAFETY ASSESSMENT …
wwwcdn.imo.orgapproved the amendment to the flow chart shown in figure 2 referred to in paragraph 27 of appendix 10 to the revised FSA guidelines, for circulation of the amended revised guidelines, as set out in the annex, as MSC-MEPC.2/Circ.12/Rev.2. 5 Member States and non-governmental organizations are invited to apply the revised