COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05158140

Not reported

Not reported

2021-12-15

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: is in good health any underlying chronic illness must be documented to be in stable condition has received a 2-dose primary series of the moderna mrna sars-cov-2 vaccine ≥5 months before receipt of study vaccine at visit 1 may have received either: a) a first booster dose of the moderna mrna sars-cov-2 vaccine ≥4 months before receipt of study vaccine at visit 1, or b) no booster dose of the moderna mrna sars-cov-2 vaccine a female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (wocbp) or is a wocbp and using an acceptable contraceptive method, or is abstinent from heterosexual intercourse

has a current sars-cov-2 infection or a known history of sars-cov-2 infection <3 months before receipt of study vaccine at visit 1 has a history of myocarditis and/or pericarditis has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (hiv) infection, functional or anatomic asplenia, or history of autoimmune disease has a coagulation disorder contraindicating intramuscular vaccinations had a recent illness with fever (defined as oral or tympanic temperature ≥100.4°f [≥38.0°c]; axillary or temporal temperature ≥99.4°f [≥37.4°c]) or received antibiotic therapy for an acute illness occurring <72 hours before receipt of study vaccine has a known malignancy that is progressing or has required active treatment <3 years before receipt of study vaccine at visit 1 received prior administration of a pneumococcal polysaccharide vaccine <5 years before study enrollment or is expected to receive a pneumococcal polysaccharide vaccine during the study outside the protocol received prior administration of a pcv <1 year before receipt of study vaccine at visit 1 or is expected to receive a pcv during the study outside the protocol received prior administration of any sars-cov-2 vaccine other than the 2-dose primary series of the moderna mrna vaccine with or without a first booster dose, or is expected to receive any sars-cov-2 vaccine during the study outside the protocol received prior monoclonal antibody treatment for sars-cov-2 infection received antiviral treatment for sars-cov-2 infection <3 months before receipt of study vaccine at visit 1 received systemic corticosteroids for ≥14 consecutive days and has not completed intervention ≥30 days before receipt of study vaccine at visit 1 received systemic corticosteroids exceeding physiologic replacement doses ≤14 days before receipt of study vaccine is currently receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine. exception: inactivated influenza vaccine allowed if given ≥7 days before or ≥15 days after receipt of study vaccine received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine received a blood transfusion or blood products (including globulin) ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study

4

Merck Sharp & Dohme LLC

50

100

Puerto Rico;United States

Healthy volunteers

N/A

850

Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110;Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114;Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110;Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114;Percentage of Participants With Vaccine-Related SAEs Among Participants Administered V114;Percentage of Participants With Vaccine-Related Serious AEs (SAEs) Among Participants Administered V110;SARS-CoV-2-specific Binding Antibody (bAb) GMT in Participants Administered Either V110 or V114;Serotype-specific OPA GMT in Participants Administered V114;Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110

None

Phase 3

[{"arm_notes": "V110 + concomitant mRNA-1273", "treatment_id": 2352, "treatment_name": "Mrna-1273+pneumococcal vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "V110 + non-concomitant mRNA-1273", "treatment_id": 2352, "treatment_name": "Mrna-1273+pneumococcal vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "V114 + concomitant mRNA-1273", "treatment_id": 2352, "treatment_name": "Mrna-1273+pneumococcal vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "V114 + non-concomitant mRNA-1273", "treatment_id": 2352, "treatment_name": "Mrna-1273+pneumococcal vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}]