Acute lower respiratory infection
Conditions
Brief summary
Solicited local and systemic ARs through 7 days after each injection., Unsolicited AEs through 28 days after each injection., MAAEs from Day 1 to EoS., AESIs from Day 1 to EoS., SAEs from Day 1 to EoS., AEs leading to discontinuation from Day 1 to EoS.
Detailed description
Number and percentage of participants with RTI, LRTI, severe LRTI, very severe LRTI, and hospitalizations associated with RSV or hMPV from Day 1 through EoS., GMT of serum RSV and hMPV neutralizing antibody across prespecified study timepoints. In Part C and Part D, GMT and GMC will be done only for RSV., GMC of serum RSV F and hMPV F– binding antibody across prespecified study timepoints. In Part C and Part D, GMT and GMC will be done only for RSV., GMFR of postbaseline/baseline neutralizing antibody titers and binding antibody concentrations across prespecified study timepoints., Frequency, magnitude, and/or phenotype of vaccine-specific T-cell responses measured by flow cytometry or other methods. Cellular immunogenicity will not be done in Part B and Part D.
Interventions
Sponsors
Moderna Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited local and systemic ARs through 7 days after each injection., Unsolicited AEs through 28 days after each injection., MAAEs from Day 1 to EoS., AESIs from Day 1 to EoS., SAEs from Day 1 to EoS., AEs leading to discontinuation from Day 1 to EoS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and percentage of participants with RTI, LRTI, severe LRTI, very severe LRTI, and hospitalizations associated with RSV or hMPV from Day 1 through EoS., GMT of serum RSV and hMPV neutralizing antibody across prespecified study timepoints. In Part C and Part D, GMT and GMC will be done only for RSV., GMC of serum RSV F and hMPV F– binding antibody across prespecified study timepoints. In Part C and Part D, GMT and GMC will be done only for RSV., GMFR of postbaseline/baseline neutralizing antibody titers and binding antibody concentrations across prespecified study timepoints., Frequency, magnitude, and/or phenotype of vaccine-specific T-cell responses measured by flow cytometry or other methods. Cellular immunogenicity will not be done in Part B and Part D. | — |
Countries
Latvia, Poland, Spain
Outcome results
None listed