Adjuvant:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
Polyacrylamide Gel Electrophoresis:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
Immunopeptidomics:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
Recombinant:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
Vaccines:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
Clinical Proteomics:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
Polymerase Chain Reaction:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
Injection:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
Saline:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
Blocking Assay:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
Mutagenesis:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
Construct:Article Title:
Article Snippet: Name of Sponsor/Company: Novavax, Inc. Name of Product: SARS-CoV-2 rS Name of Active Ingredient: SARS-CoV-2 rS + Matrix-M1 adjuvant Title of Study: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1TM Adjuvant in Adult Participants ≥ 18 Years with a Pediatric Expansion in Adolescents (12 to < 18 Years) Principal Investigator: This is a multicenter study.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 89 • Any additional assays to measure immune response, protection, or potential safety signals.
Article Title: A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 spike protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 133 Concomitant medications will be summarized by treatment group and preferred drug name as coded using the World Health Organization drug dictionary.
Article Title:
Article Snippet: There is currently no evidence for immunoenhancement in nonclinical testing of SARS-CoV-2 rS or other Novavax baculovirus-Sf9-based vaccines taken into nonclinical evaluation or clinical trials.
Article Title:
Article Snippet: In support of the development of SARS-CoV-2 rS, Novavax has obtained nonclinical pharmacology data concerning several SARS-CoV-2 S protein variants, toxicity data concerning SARS-CoV-2 rS with Matrix-M1 adjuvant, and prior toxicity data concerning other viral glycoproteins manufactured in the baculovirus-Sf9 system and formulated with Matrix-M1 adjuvant.
Article Title: Immunogenicity of a Fourth Homologous Dose of NVX-CoV2373
Article Snippet: Novavax, Inc. SARS-CoV-2 rS Protocol No. 2019nCoV-101 Clinical Study Protocol Amendment 8 - Part 2 Page 114 However, if an underlying disease or new condition is identified that accounts for the clinically significant laboratory finding, the disease or condition should be documented as the AE instead of the laboratory abnormality.
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![Anti-Spike (rS) IgG isotypes in subjects primed with either with mRNA vaccines (mRNA-1273 or BNT162b2) or the protein-based subunit COVID-19 vaccine <t>(NVX-CoV2373).</t> Pre-booster (day 0), post-booster NVX-CoV2373 (day 28) or mRNA (BNT162b2) vaccines (day 29). A. Schematic of the vaccines administered to subjects. ELISA-based quantitation [Geometric Mean Titers (GMT) with 95% confidence intervals (CI)] of IgG isotypes is shown in B–E : Gray – mRNA vaccines x3 +NVX-CoV2373 (N=19), dark-blue – NVX-CoV273 x3 + NVX-CoV273 (N=18), F–I: Light-blue – NVX-CoV273 x2 + BNT162b2 (N=24 for Day 0 and N=30 for Day 29). Statistical analysis was performed by the two-tailed Mann–Whittney test. **p<0.01, ***p < 0.001, ****p < 0.0001.n.s. indicates not significant.](https://med-rxiv-images-cdn.bioz.com/dois_ending_with_67/10__1101_slash_2025__03__19__25324267/10__1101_slash_2025__03__19__25324267___F1.large.jpg)
