safety, tolerability, and immunogenicity of v110 or v114 co-administered with a booster dose of mrna-1273 in healthy adults (v110-911)

Conditions: Pneumococcal Infection

Summary: the purpose of this study is to evaluate the concomitant and non-concomitant use of messenger ribonucleic acid (mrna) mrna-1273, the nucleoside-modified mrna vaccine for active immunization to prevent coronavirus disease (covid-19) caused by severe acute respiratory syndrome coronavirus (sars-cov-2), with a 23-valent pneumococcal polysaccharide vaccine (v110) for the prevention of pneumococcal disease, or a 15-valent pneumococcal conjugate vaccine (v114) indicated for the prevention of invasive pneumococcal disease.


Eligibility criteria:
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 exclusion criteria: * 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