Transcription of CLINICAL STUDY PROTOCOL - Moderna
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CLINICAL STUDY PROTOCOL - Moderna
ModernaTX, Inc. 20 Aug 2020 PROTOCOL mRNA-1273-P301, Amendment 3 mRNA-1273 Confidential Page 1 CLINICAL STUDY PROTOCOL PROTOCOL Title: A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled STUDY to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older PROTOCOL Number: mRNA-1273-P301 Sponsor Name: Legal Registered Address: ModernaTX, Inc. 200 Technology Square Cambridge, MA 02139 Sponsor Contact and Medical Monitor: Tal Zaks, MD, PhD, Chief Medical Officer ModernaTX, Inc. 200 Technology Square, Cambridge, MA 02139 Telephone: 1-617-209-5906 e-mail: Regulatory Agency Identifier Number(s): IND: 19745 Amendment Number: 3 Date of Amendment 3: 20 Aug 2020 Date of Amendment 2: 31 Jul 2020 Date of Amendment 1: 26 Jun 2020 Date of Original PROTOCOL : 15 Jun 2020 CONFIDENTIAL All financial and nonfinancial support for this STUDY will be provided by ModernaTX, Inc.
All participants will be assessed for efficacy and safety endpoints and provide a nasopharyngeal (NP) swab sample and blood sample before the first and second dose of IP in addition to a series of post-dose blood samples for immunogenicity through 24 months after the second dose of IP. Efficacy assessments will include surveillance for
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