RSV
Conditions
Interventions
Product Name: mRNA-1345
Product Code: mRNA-1345
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intramuscular use
Sponsors
ModernaTX, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy young adults =18 to =49 years of age, women of child-bearing potential =18 to =40 years of age, healthy older adults =65 to =65 years) yes F.1.3.1 Number of subjects for this age range 317
Exclusion criteria
Exclusion criteria: - Has Screening laboratory values Grade =1 (younger adult, women of child-bearing potential, and pediatric participants) or >Grade 1 (older adult participants, including Japanese older adult participants). - Is acutely ill or febrile on the day of the first injection. - Has a significant medical history, including but not limited to: - Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection. - Chronic hepatitis or suspected active hepatitis. - Bleeding disorder that is considered a contraindication to intramuscular (IM) injection or phlebotomy. - Dermatologic conditions that could affect local solicited adverse reaction (AR) assessments. - Any history of allergic or anaphylactic reactions following a vaccination that required medical intervention. - Autoimmune disease except for Hashimoto's disease. - Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of enrollment. Topical tacrolimus is allowed if not used within 14 days prior to the day of enrollment. Inhaled, nasal, and topical steroids are allowed. - Intravenous blood products (red cells, platelets, and immunoglobulins [Ig]) within 3 months prior to enrollment. - Has received or plans to receive any licensed or authorized vaccine, to include Coronavirus Disease 2019 (COVID-19) vaccines, = 28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection. Non-study vaccinations should not be delayed. - Has a history of myocarditis, pericarditis, or myopericarditis. Specific exclusion criteria for older adults (Cohorts 7-11 and 15): - Known history of poorly controlled hypertension (per determination of the Investigator) or systolic blood pressure >160 millimeters of mercury (mmHg) at the Screening visit. - Known history of hypotension or systolic blood pressure <85 mmHg at the Screening visit. - Poorly controlled diabetes mellitus (per determination of the Investigator). - Diagnosis of significant chronic pulmonary disease (per determination of the Investigator) (such as, chronic obstructive pulmonary disease, asthma). - Significant chronic cardiovascular disease (per determination of the Investigator). - Resides in a nursing home. - Anticipates the need for immunosuppressive treatment at any time during participation in the study. - Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer and cervical carcinoma in-situ). Specific exclusion criteria for children 12 to 59 months of age (Cohorts 5 and 6): - Has received any monoclonal antibody at any time prior to the Screening visit. - Prior hospitalization for RSV disease in the last 2 years. - Receipt of any prior systemic immunosuppressants or immune-modifying drugs. - Any history of febrile seizures (inclusive of single simple febrile seizure). - History of epilepsy. - History of meningitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objectives of this trial are to: - evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults, including Japanese older adults, - evaluate the tolerability and reactogenicity of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults, - evaluate the tolerability and reactogenicity of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults, and - evaluate the tolerability and reactogenicity of 3 injections of 2 dose levels of mRNA-1345 given 56 days apart in RSV-seropositive children.;Secondary Objective: The secondary objectives of this trial are to: - evaluate the antibody (Ab) response to each vaccine dose level in healthy younger adults, women of child-bearing potential, and older adults, including Japanese older adults, - evaluate the Ab response to both 1 and 3 vaccine injections in healthy younger adults at the middle dose level of mRNA-1345, - evaluate the Ab response to a vaccine booster injection given approximately 12 and 24 months after the primary injection in older adults, and - evaluate the Ab response to each vaccine dose level in RSV-seropositive children.;Primary end point(s): - Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) - Number of Participants with Unsolicited Adverse Events (AEs) - Number of Participants with Serious AEs or Medically Attended AEs (MAAEs);Timepoint(s) of evaluation of this end point: - Up to Day 737 (7 days after each injection) - Up to Day 758 (28 days after the last injection) - Up to Day 1095 (End of Study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Geometric Mean Titer (GMT) of Serum RSV Neutralizing and Binding Antibodies (Abs) - Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers - Proportion of Participants with =2-fold and =4-fold Increases in Ab Titers from Baseline;Timepoint(s) of evaluation of this end point: - Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11). Time frame applies to all secondary endpoints. | — |
Countries
United States
Contacts
Public ContactModerna Clinical Trials
ModernaTX, Inc.
Outcome results
None listed