Full name
A Phase 1/2, Randomized, Controlled Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Investigational Flu Seasonal/SARS-CoV-2 Combination mRNA Vaccine in Adults
NCT Number
NCT06680375
Geography
US
Locations
United States
Primary Endpoints
- Percentage of participants with increase in grading for at least one laboratory value from administration of study intervention in Phase 1. From Day 1 to Day 8
- Percentage of participants with solicited administration site adverse events (AEs) in Phase 1 and Phase 2. From Day 1 to Day 7
- Percentage of participants with solicited systemic AEs in Phase 1 and Phase 2. From Day 1 to Day 7
- Percentage of participants with unsolicited AEs in Phase 1 and Phase 2. From Day 1 to Day 28
- Percentage of participants with medically attended adverse events (MAAEs) in Phase 1 and Phase 2. From Day 1 to Day 183 (study end)
- Percentage of participants with serious adverse events (SAEs) in Phase 1 and Phase 2. From Day 1 to Day 183 (study end)
- Percentage of participants with adverse events of special interest (AESIs) in Phase 1 and in Phase 2 (selected study intervention from Phase 1). From Day 1 to Day 183 (study end)
- Geometric mean titer (GMT) ratio of antigen 1 antibody in Phase 1 for investigational mRNA Flu/COVID-19 (pooled dose 1 and dose 2) and mRNA flu vaccines. At Day 29
- GMT ratio of antigen 1 antibody in Phase 2 for selected investigational mRNA Flu/COVID-19 vaccine from phase 1 and licensed Flu Seasonal vaccine co-administered with a licensed mRNA COVID-19 vaccine. At Day 29
- GMT ratio of antigen 2 antibody in Phase 1 for investigational mRNA Flu/COVID-19 (pooled dose 1 and dose 2) and mRNA flu seasonal vaccines. At Day 29
- GMT ratio of antigen 2 antibody in Phase 2 for selected investigational mRNA Flu/COVID-19 vaccine from Phase 1 and licensed Flu Seasonal vaccine co-administered with a licensed mRNA COVID-19 vaccine. At Day 29
- GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) in Phase 1 for investigational mRNA Flu/COVID-19 (pooled dose 1 and dose 2) and mRNA COVID-19 vaccines. At Day 29
- GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) in Phase 2. At Day 29
External Link
https://clinicaltrials.gov/study/NCT06680375
Order
3
Disease
Version
Phase
1/2
Status
Active, not recruiting