Respiratory
Conditions
Interventions
mRNA1273
Placebo group
Sponsors
Moderna TX Inc
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Participants must have been previously enrolled in the mRNA-1273-P203 study, are actively participating in Part 1A or Part 1B, and are at least 5 months from the last dose. 2. Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (BD-Day 1).
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding. Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature = 38.0°C/= 100.4°F. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator’s judgment. History of a diagnosis or condition (after enrollment in Part 1A) that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety: • Suspected active hepatitis • Has a bleeding disorder that is considered a contraindication to IM injection or phlebotomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and reactogenicity of 100 ?g mRNA-1273 vaccine administered in 2 doses 28 days apart | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the persistence of the immune response of mRNA-1273 vaccine (100 ?g) administered in 2 doses 28 days apart, as assessed by the level of SARS-CoV-2 S2P-specific bAb through 1 year after Dose 2 | — |
Countries
Kenya
Contacts
Public ContactDr. Videlis Nduba
Principal Investigator
Outcome results
None listed