COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05436834

Not reported

Not reported

2022-06-29

Not recruiting

nonRCT

Non-randomized

Sequential assignment

Open label

multi-center

Prevention

inclusion criteria: if the participant has a chronic disease (that is, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus [hiv] infection), the disease should be stable, per investigator assessment, so that the participant can be considered eligible for inclusion. stable diseases are those which have had no change in their status or in the medications required to control them in the 6 months prior to screening visit. note: a change in medication for dose optimization (that is, insulin dose changes, adjustments for age-related weight gain), change within class of medication, or reduction in dose are not considered signs of instability. in the investigator's opinion, the parent(s)/legally authorized representative(s) (lar[s]) understand and are willing and physically able to comply with protocol-mandated follow-up, including all procedures and provide written informed consent. this includes inability to draw baseline blood samples (minimum amount needed). the participant is 2 years or older and has a body mass index (bmi) at or above the 2nd percentile according to world health organization (who) child growth standards at the screening visit. or the participant is less than 2 years of age and the participant's height and weight are both at or above the 2nd percentile according to who child growth standards at the screening visit. special inclusion criteria for participants aged 6 months to < 12 months: the participant was born at full-term (≥ 37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg). inclusion criteria for part 2: the participant must have received 2 doses of mrna-1273, approximately 28 to 35 days apart, as 25-μg primary series, and 2nd dose was given at least 4 months prior to enrollment.

has a known history of sars-cov-2 infection (that is, reported ae of coronavirus disease 2019 [covid-19] or asymptomatic sars-cov-2 infection during study mrna-1273-p204) 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°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 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, this applies to vaccines other than the 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: congenital or acquired immunodeficiency, other than well-controlled hiv infection. chronic hepatitis or suspected active hepatitis a bleeding disorder that is considered a contraindication to im injection or phlebotomy dermatologic conditions that could affect local solicited ar assessments 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.

1

ModernaTX, Inc.

0

5

Puerto Rico;United States

Healthy volunteers

N/A

931

Geometric Mean (GM) of the Serum Antibody (Ab) Level Against SARS-CoV-2 (Omicron BA.1 and Ancestral SARS-CoV-2);GM of the Serum Ab Level Against SARS-CoV-2 (Omicron BA.1 and Ancestral SARS-CoV-2);Number of Participants with Adverse Events of Special Interest (AESI);Number of Participants with AEs Leading to Withdrawal;Number of Participants with Medically-Attended AEs (MAAEs);Number of Participants with Serious AEs (SAEs);Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);SRR of Vaccine Recipients of SARS-CoV-2 VOC (Omicron BA.1 and Ancestral SARS-CoV-2)

None

Phase 3

[{"arm_notes": "IM", "treatment_id": 2441, "treatment_name": "Mrna-1273.214", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]