CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Biological: mRNA-1273: 50 mcgWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug355 Biological: mRNA-1273: 100 mcg Wiki 1.00
drug974 GENUS device (Active Settings) Wiki 1.00
drug975 GENUS device (Sham Settings) Wiki 1.00
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D000544 Alzheimer Disease NIH 0.58

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002511 Alzheimer disease HPO 0.58

There is one clinical trial.

Clinical Trials

1 A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older

This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 SARS-COV-2 vaccine in adults 18 years of age or older.

NCT04405076 SARS-CoV-2 Biological: Biological: mRNA-1273: 50 mcg Other: Placebo Biological: Biological: mRNA-1273: 100 mcg

Primary Outcomes

Measure: Solicited local and systemic adverse reactions (ARs)

Time: 7 days post-vaccination

Measure: Unsolicited adverse events (AEs)

Time: 28 days post-vaccination

Measure: Medically-attended adverse events (MAAEs)

Time: Month 0 through Month 13

Measure: Serious adverse events (SAEs)

Time: Month 0 through Month 13

Measure: Change in the measure of clinical safety laboratory values in Cohort 2 from baseline

Time: Through 1 month after last vaccination

Measure: The number and percentage of participants with abnormalities in blood pressure, temperature, HR or respiratory rate will be assessed.

Time: Through 1 year after last vaccination

Measure: The number and percentage of participants with abnormalities in physical examinations will be assessed

Time: Through 1 year after last vaccination

Measure: Evaluate immunogenicity of mRNA-1273 by titer of SARS-CoV-2-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA)

Time: Through 1 year after the final dose

Secondary Outcomes

Measure: Titer of SARS-CoV-2-specific neutralizing antibody (nAb)

Time: Through 1 year post last vaccination

Description: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer either from below the limit of detection (LOD) or lower limit of quantification (LLOQ) to equal to or above LOD or LLOQ, or a 4-times higher titer in participants with pre-existing nAb titers.

Measure: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer

Time: Through 1 year post last vaccination

No related HPO nodes (Using clinical trials)