COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05137236

Not reported

Not reported

2021-11-30

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as bilateral tubal ligation >1 year prior to screening, bilateral oophorectomy, hysterectomy, or menopause. female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of vaccination (day 1), practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to day 1, agreed to continue adequate contraception through 3 months following the last vaccine administration, and not currently breastfeeding. participant must have received their second dose of the mrna-1273 primary series at least 6 months prior to screening and enrollment (part a) or have received the mrna-1273 series and an mrna-1273 booster dose at least 3 months prior to screening and enrollment (part b).

had significant exposure to someone with sars-cov-2 infection or covid-19 in the past 14 days, defined by the us centers for disease control and prevention (cdc) as a close contact of someone who has covid-19. is acutely ill or febrile (temperature ≥38.0 degree celsius [°c]/100.4 degree fahrenheit [°f]) less than 72 hours prior to or at the screening visit or day 1. 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. has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. has received or plans to receive any licensed vaccine ≤28 days prior to the injection (day 1) or plans to receive a licensed vaccine within 28 days before or after the study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. has received systemic immunoglobulins or blood products within 3 months prior to the screening visit, or plans to receive these during the study. has donated ≥ 450 milliliters (ml) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study. plans to participate in an interventional clinical trial of an investigational vaccine or drug while participating in this study. note: other inclusion and exclusion criteria may apply.

8

ModernaTX, Inc.

18

100

United States

Healthy volunteers

N/A

540

Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29;Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29;Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29;Part A: GMT of SARS-CoV-2 Specific Binding Antibody (bAb) Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29;Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29;Part B: GMFR of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Day 29;Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Day 29;Part B: GMT of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Day 29;Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Day 29;Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Day 29;Parts A and B: Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs);Parts A and B: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs);Parts A and B: Number of Participants with Unsolicited Adverse Events (AEs)

None

Phase 2

[{"arm_notes": "single intramuscular (IM) injection of mRNA-1283 at Dose Level 1 on Day 1", "treatment_id": 830, "treatment_name": "Mrna-1283", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "single IM injection of mRNA-1283 at Dose Level 2 on Day 1.", "treatment_id": 830, "treatment_name": "Mrna-1283", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "single IM injection of mRNA-1283 at Dose Level 3 on Day 1.", "treatment_id": 830, "treatment_name": "Mrna-1283", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "single IM injection of mRNA-1283.211 at Dose Level 1 on Day 1.", "treatment_id": 2068, "treatment_name": "Mrna-1283.211", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "single IM injection of mRNA-1283.211 at Dose Level 2 on Day 1.", "treatment_id": 2068, "treatment_name": "Mrna-1283.211", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "single IM injection of mRNA-1273 on Day 1.", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "single IM injection of mRNA-1283.529 as a second booster at Dose Level 1 on Day 1.", "treatment_id": 2426, "treatment_name": "Mrna-1283.529", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "single IM injection of mRNA-1283.529 as a second booster at Dose Level 2 on Day 1.", "treatment_id": 2426, "treatment_name": "Mrna-1283.529", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]