Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Conditions
Interventions
Product Name: mRNA-1273.214
Pharmaceutical Form: Injection
Product Name: mRNA-1273.815
Pharmaceutical Form: Injection
Sponsors
ModernaTX, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The participant is 6 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Has a known history of SARS-CoV-2 infection (that is, reported adverse event [AE] of COVID-19 or asymptomatic SARS-CoV-2 infection during Study mRNA-1273-P204 at the time of rollover into mRNA-1273-P306 or during Part 1 at the time of rollover into Part 3) in the 90 days prior to dosing in this study. - Is acutely ill or febrile 24 hours prior to or at the Screening Visit. Fever is defined as a body temperature = 38.0°Celsius (C)/= 100.4°Fahrenheit (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. - For Parts 1 and 4, participant has previously been administered an investigational or approved CoV (that is, SARS-CoV-2, SARS-CoV, Middle East respiratory syndrome coronavirus [MERS-CoV]) vaccine. For Part 2, participant who received any approved/investigational CoV vaccine are ineligible to participate except for those who received mRNA-1273 (prototype) vaccine. - Has undergone treatment with investigational or approved agents for prophylaxis against COVID-19 (including receipt of SARS-CoV-2 monoclonal antibodies for prophylaxis or treatment) within 90 days prior to enrollment. - Has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG] or immediate allergic reaction of any severity to polysorbate). - Has a medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results. - Has a history of diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety, specifically the following: a) Congenital or acquired immunodeficiency, other than well-controlled HIV infection. b) Chronic hepatitis or suspected active hepatitis c) A bleeding disorder that is considered a contraindication to IM injection or phlebotomy d) Dermatologic conditions that could affect local solicited adverse reaction (AR) assessments e) Any prior diagnosis of malignancy (excluding nonmelanoma skin cancer) - Has received the following: Any routine vaccination with inactivated or live vaccine(s) within 14 days prior to study vaccination or plans to receive such a vaccine through 14 days following study vaccination. Note: This excludes influenza vaccine that may be given anytime, but ideally at least 7 days before study dose. If a participant receives an influenza vaccine, this should be captured within the concomitant medication electronic case report form (eCRF). - Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of enrollment (for corticosteroids, =1 milligrams (mg)/kg/day or = 10 mg/day prednisone equivalent, if participant weighs >10 kg). Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids, and palivizumab are allowed. - Intravenous (IV) or subcutaneous (SC) blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Parts 1 and 2: - To evaluate the safety and reactogenicity of mRNA-1273.214 vaccine 2-dose primary series (28 days apart) or single booster dose (BD) (at least 4 months post-Dose 2) in participants aged 6 months to <6 years; - To infer the effectiveness of mRNA-1273.214 primary series or BD, based on immune responses against SARS-CoV-2 and its variants of concern (VOC) (Omicron BA.1) in participants aged 6 months to <6 years. Part 3: - To evaluate the safety and reactogenicity of mRNA-1273.815 vaccine (BD) after an age-appropriate regimen of an approved COVID-19 vaccine in participants aged 6 months to <6 years. Part 4: - To evaluate the safety and reactogenicity of mRNA-1273.815 vaccine (single dose) in Cohort A or as a 2 dose series in Cohort B; - To infer the effectiveness mRNA-1273.815 (single dose) based on immune responses against SARS-CoV-2 VOC (Omicron XBB.1.5) in participants aged 2 to <5 years (Part 4 Cohort A) having evidence of prior SARS-CoV-2 infection.;Secondary Objective: Parts 1 and 2: - To evaluate the immune responses against SARS-CoV-2 VOC (Omicron BA 1) and ancestral SARS-CoV-2 induced by mRNA-1273.214 primary series (2 doses) in participants aged 6 months to < 6 years, compared with those of mRNA-1273 primary series; - To evaluate the immune responses against SARS-CoV-2 VOC (Omicron BA.1) and ancestral SARS-CoV-2 induced by mRNA-1273.214 BD in participants aged 6 months to < 6 years, compared with the immune responses against ancestral SARSCoV- 2 induced by mRNA-1273 primary series. Part 3: - To evaluate the immune responses against SARS-CoV-2 VOC (Omicron XBB.1.5) induced by mRNA-1273.815 BD in participants aged 6 months to <6 years who were previously vaccinated with an age-appropriate regimen of an approved COVID-19 vaccine. Part 4: - To assess mRNA-1273.815 (single dose) immune responses against SARS-CoV-2 VOC (Omicron XBB.1.5) in Part 4 Cohort A.;Primary end point(s): 1. Number of Participants with Solicited Local and Syst | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. SRR against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration Regardless of prior SARS-CoV-2 Infection 2. GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection 3. SRR against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection ;Timepoint(s) of evaluation of this end point: Endpoint #1: Day 57 Endpoint #2 and #3: Up to Day 57 | — |
Countries
Argentina, Chile, Colombia, Dominican Republic, Mexico, Panama, United States
Contacts
Public ContactClinical Trials Support Center
ModernaTX, Inc.
Outcome results
None listed