A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
- 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.
- Short title
- A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
- Official title
- A Phase 1, Randomized, Observer-blind, Placebo-controlled, Age De-escalation Study of the Safety, Tolerability, and Immunogenicity of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2029-08-31
- First posted
- 2023-02-24
- Registry last updated
- 2026-06-26
- Primary completion date
- 2029-08-31
- Start date
- 2023-02-15
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- ModernaTX, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05743881
- ClinicalTrials.gov ID
- NCT05743881
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Triple masking
- Masking description
- Parts A and B are blinded, and Part C is open-label. Part B Extension is unblinded.
- Masked roles
- Participants, Investigators, Outcome assessors
Main Study: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: Up to Day 120 (7 days after each injection)
Main Study: Number of Participants with Unsolicited Adverse Events (AEs)
Timeframe: Up to Day 141 (28 days after each injection)
Main Study: Number of Participants with Medically-Attended Adverse Events (MAAEs)
Timeframe: 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
Timeframe: Day 1 through Day 730
Part B Extension: Number of Participants with MAAEs, AESIs and SAEs
Timeframe: 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
Timeframe: Day 1 of the Extension to EoS (up to 3 years)
Main Study: Number of Participants with Respiratory tract Illness (RTI), LRTI, Severe LRTI, Very Severe LRTI, and Hospitalizations Associated with RSV or hMPV
Timeframe: Day 1 through Day 730
Main Study (Parts A and B): Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies
Timeframe: Baseline up to Month 12
Main Study (Part C): GMT of Serum RSV Neutralizing Antibodies
Timeframe: Baseline up to Month 12
Main Study (Parts A and B): Geometric Mean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies
Timeframe: Baseline up to Month 12
Main Study (Part C): GMC of Serum RSV F-Binding Antibodies
Timeframe: Baseline up to Month 12
Main Study: Geometric Mean Fold-Rise (GMFR) of Postbaseline/baseline Neutralizing Antibody Titers and Binding Antibody
Timeframe: Month 12
Main Study: Number of Participants with Vaccine-specific T-cell Responses Measured by Flow Cytometry
Timeframe: Baseline up to Month 12
Part B Extension: Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies
Timeframe: Day 1 of the Extension up to EoS (up to 3 years)
Part B Extension: Geometric Mean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies
Timeframe: Day 1 of the Extension up to EoS (up to 3 years)
Part B Extension: Geometric Mean Fold-Rise (GMFR) of Postbaseline/baseline Neutralizing Antibody Titers and Binding Antibody
Timeframe: Day 1 of the Extension up to EoS (up to 3 years)
Part B Extension: Number of Participants with Vaccine-specific T-cell Responses Measured by Flow Cytometry
Timeframe: Day 1 of the Extension up to EoS (up to 3 years)
- Sex
- All
- Age groups
- Children
- Minimum age
- 5 Months
- Maximum age
- 24 Months
- Healthy volunteers
- No
- 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.
- 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.
- 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.
• For Part B Extension, there are no specific exclusion criteria.
- Matrix Clinical ResearchLos Angeles, United States
- Meridian Clinical ResearchWashington D.C., United States
- DM Clinical Research- River ForestMelrose Park, United States
- MedPharmics - Platinum - PPDSLafayette, United States
- Duke Vaccine and Trials UnitDurham, United States
- Velocity Clinical Research - ProvidenceProvidence, United States
- Palmetto Pediatrics, PANorth Charleston, United States
- Vanderbilt Vaccine Research ProgramNashville, United States
- CyFairHouston, United States
- Pediatric AssociatesHouston, United States
- Village PediatricsPlano, United States
- Pediatric CenterRichmond, United States
- CEVAXIN DavidDavid, Panama
- CEVAXIN ChorreraLa Chorrera, Panama
- CEVAXIN Avenida MexicoPanama City, Panama
- CEVAXIN 24 de DiciembrePanama City, Panama
- Norfolk and Norwich University HospitalsNorwich, United Kingdom
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