COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04796896

Not reported

Not reported

2021-03-15

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

key inclusion criteria: for participants with chronic diseases (such as, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus [hiv] infection), the disease should be stable, per investigator assessment. investigator assessment that the parent(s)/legally acceptable representatives understand and are willing and physically able to comply with protocol mandated follow up, including all procedures, written informed consent is provided, and participants provide assent. for children 2 years of age or older has a body mass index at or above the third percentile according to world health organization (who) child growth standards at the screening visit. for children 6 months to <12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms (kg). for female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection (day 29) and the third dose in part 3 (day 149/booster dose day 1), and not currently breastfeeding. key

- known history of sars-cov-2 infection within 2 weeks prior to administration of vaccine or known close contact with anyone with laboratory-confirmed sars-cov-2 infection or covid-19 within 2 weeks prior to administration of vaccine. - prior administration of an investigational or approved cov (such as, sars-cov-2, sars cov, middle east respiratory syndrome cov) vaccine. - treatment with investigational or approved agents for prophylaxis against covid 19 (such as, receipt of sars-cov-2 monoclonal antibodies) within 6 months prior to enrollment. - known hypersensitivity to a component of the vaccine or its excipients. - 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. - history of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety. - received any non-study vaccine within 14 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine) - received intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to day 1 - participated in an interventional clinical study within 28 days prior to day 0 or plans to donate blood products while participating in this study.

2

ModernaTX, Inc.

0

11

Canada;United States

Healthy volunteers

N/A

11950

Geometric Mean (GM) Value of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody;GM Value of Post-Booster Dose SARS-CoV-2 Specific Serum Antibody;Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C), Myocarditis and/or Pericarditis;Number of Participants with AEs Leading to Discontinuation From Study Post-Booster Dose Through the Last Day of Study Participation;Number of Participants with Medically-Attended AEs (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19;Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Seroresponse Rate of Post-Booster Dose of Vaccine Recipients;Seroresponse Rate of Vaccine Recipients

None

Phase 2/Phase 3

[{"arm_notes": "nan", "treatment_id": 2623, "treatment_name": "Mrna-1273+mrna-1273.214", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]