Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911)
Condition: Pneumococcal Infection
MeSH terms: Pneumococcal Infections
Intervention: V110; V114; mRNA-1273; Placebo for V110; Placebo for V114
Intervention description: Single intramuscular (IM) dose of 0.5 mL V110, a pneumococcal polysaccharide vaccine (PCV), containing the 23 serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F; Single IM dose of 0.5 mL V114 a 15-valent PCV containing the 15 serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F; Single IM dose of 50 μg/0.25 mL mRNA-1273; Single IM dose of 0.5 mL placebo for V110; Single IM dose of 0.5 mL placebo for V114
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 850.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

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