Active, not recruiting
Phase 1
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
Condition(s) studied
Respiratory Syncytial VirusHuman Metapneumovirus
Investigational drug(s) / intervention(s)
mRNA-1345mRNA-1365PlaceboNimenrix
mRNA-1345: Sterile liquid for injection
mRNA-1365: Sterile liquid for injection
Placebo: 0.9% sodium chloride (normal saline) solution for injection
Nimenrix: Solution for injection
Study summary
The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to \<24 months.
Eligibility
Inclusion Criteria:
* The participant is 8 months to \<24 months (Part A), 5 months to \<8 months (Part B), or 8 months to \<12 months (Part C) of age at the time of randomization (Day 1/Baseline visit), who is in good general health, in the opinion of the Investigator, based on review of medical history and screening physical examination.
* In the Investigator's opinion, the parent(s)/ legally authorized representative (LAR)(s) understand and are willing and physically able to comply with protocol-mandated follow up, including all procedures, and provide written informed consent.
* The participant is growing normally for age in the opinion of the site clinician in the months prior to enrollment.
* The participant was born at full-term (≥37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg).
* For Part C Cohort 7: participant must have received nirsevimab ≥6 months prior to Day 1 Visit.
* For Part C Cohort 8: participant was eligible at any time since birth, according to national guidelines, to receive nirsevimab prior to Day 1 Visit but did not do so.
Exclusion Criteria:
* Has a known history of symptomatic RSV (Part A: within 3 months; Part B and Part C: since birth) or hMPV infection (Part A: within 3 months; Part B: since birth) prior to administration of the first dose of investigational product (IP) or has a known close contact with anyone with laboratory-confirmed RSV (Parts A, B, and C) or hMPV infection (Parts A or B) within 14 days prior to administration of the first dose of IP.
* Is acutely ill or febrile 24 hours prior to or at the screening visit. Fever is defined as a body temperature ≥38.0°Celsius/≥100.4°Fahrenheit. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows.
* Has previously been administered an investigational or approved vaccine for prevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) infection or if the participant's mother received an investigational or approved vaccine for the prevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) infection during pregnancy.
* Has received investigational or approved agents for prophylaxis against RSV or hMPV (for example, monoclonal antibodies) or is intending to receive these during the course of the study. For Part C (Cohort 7 only), use of nirsevimab ≥6 months before Day 1 Visit is allowed.
* Has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to a previous dose of an mRNA vaccine or any of its components (including polyethylene glycol or immediate allergic reaction of any severity to polysorbate).
* Has a medical condition that, according to the Investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results.
Note: Other protocol-defined inclusion/exclusion criteria apply.
Inclusion Criteria:
* For Part B Extension: participants enrolled and dosed in Part B (Cohorts 3 to 6); either reached the end of study of the Main Study or were dosed and subsequently discontinued from the Main Study. This includes participants who were lost to follow-up, if they can be re-engaged.
* For Part B Extension: participant's parent(s)/LAR(s) has provided written informed consent for participation in Part B of the Main Study and the Part B Extension.
Exclusion Criteria:
• For Part B Extension, there are no specific exclusion criteria.
Primary outcome measure(s)
- Main Study: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) — Up to Day 120 (7 days after each injection)
- Main Study: Number of Participants with Unsolicited Adverse Events (AEs) — Up to Day 141 (28 days after each injection)
- Main Study: Number of Participants with Medically-Attended Adverse Events (MAAEs) — Day 1 through Day 730
- Main Study: Number of Participants with Adverse Event of Special Interests (AESIs), Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation — Day 1 through Day 730
- Part B Extension: Number of Participants with MAAEs, AESIs and SAEs — Day 1 of the Extension to end of study (EoS) (up to 3 years)
- Part B Extension: Number of Participants with Lower Respiratory Tract Illness (LRTI), Severe LRTI, Very Severe LRTI, and Hospitalizations Associated with RSV or hMPV — Day 1 of the Extension to EoS (up to 3 years)
Trial sites (17)
| Facility | City | Region | Status |
| Matrix Clinical Research |
Los Angeles |
California |
|
| Meridian Clinical Research |
Washington D.C. |
District of Columbia |
|
| DM Clinical Research- River Forest |
Melrose Park |
Illinois |
|
| MedPharmics - Platinum - PPDS |
Lafayette |
Louisiana |
|
| Duke Vaccine and Trials Unit |
Durham |
North Carolina |
|
| Velocity Clinical Research - Providence |
Providence |
Rhode Island |
|
| Palmetto Pediatrics, PA |
North Charleston |
South Carolina |
|
| Vanderbilt Vaccine Research Program |
Nashville |
Tennessee |
|
| CyFair |
Houston |
Texas |
|
| Pediatric Associates |
Houston |
Texas |
|
| Village Pediatrics |
Plano |
Texas |
|
| Pediatric Center |
Richmond |
Texas |
|
| CEVAXIN David |
David |
Chiriquí Province |
|
| CEVAXIN Chorrera |
La Chorrera |
Panamá Oeste Province |
|
| CEVAXIN Avenida Mexico |
Panama City |
Panama |
|
| CEVAXIN 24 de Diciembre |
Panama City |
Panama |
|
| Norfolk and Norwich University Hospitals |
Norwich |
United Kingdom |
|
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