Respiratory Syncytial Virus
Conditions
Keywords
Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, RSV Seropositive, Safety, Pediatric, Vaccines
Brief summary
The primary objectives of this study 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; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.
Interventions
BIOLOGICALmRNA-1345
Formulation for injection
DRUGPlacebo
0.9% sodium chloride (normal saline) injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
For older adult Cohorts 7, 8, 9, 10, and 11, the second booster injection on Day 730 (Month 24) will be open-label.
Eligibility
Sex/Gender
ALL
Age
12 Months to 79 Years
Healthy volunteers
Yes
Inclusion criteria
Key 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 \<80 years of age, Japanese older adults ≥ 60 years of age, and children ≥12 to \< 60 months of age. * Willing and physically able to comply with protocol-mandated follow-up, including all procedures. * Adult participant or parent(s)/legal guardian(s) of pediatric participants has provided written informed consent for participation in this study, including all evaluations and procedures as specified by the protocol. Specific inclusion criteria for adults (younger adults, women of child-bearing potential, and older adults \[including Japanese older adults\]): * Has a body mass index (BMI) from ≥18 kilogram (kg)/meter (m)\^2 to ≤35 kg/m\^2. * Female participants of non-child-bearing potential. This criterion does not apply for women of child-bearing potential Cohorts 12, 13, and 14. * Female participants of child-bearing potential may be enrolled in the study, if the participant: 1) has a negative urine pregnancy test at Screening and on the day of vaccination; 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination; 3) has agreed to continue adequate contraception through 3 months following the last injection; and 4) is not currently breastfeeding. Specific inclusion criteria for children 12 to 59 months of age: * Seropositive for RSV-neutralizing Abs at Screening. * Has received routine immunizations appropriate for age per local guidance. * Current height and weight above the third percentile for age. Specific inclusion criteria for Japanese older adults: * Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan. Key
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 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 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. Nonstudy vaccinations should not be delayed. * Has a history of myocarditis, pericarditis, or myopericarditis. Specific
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 758 (28 days after the last injection) |
| Number of Participants with Serious AEs or Medically Attended AEs (MAAEs) | Up to Day 1095 (End of Study) |
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 737 (7 days after each injection) |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean Titer (GMT) of Serum RSV Neutralizing and Binding Antibodies (Abs) | 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) |
| Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers | 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) |
| Proportion of Participants with ≥2-fold and ≥4-fold Increases in Ab Titers from Baseline | 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) |
Countries
United States
Outcome results
None listed