A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Phase
Recruitment status
Active, not recruiting
Participants
Lead sponsor
ModernaTX, Inc.
Start date
Number of sites

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
Registry reports results
Listing at source
Recruitment status
Active, not recruiting
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Registry sponsor category
Lead sponsor
ModernaTX, Inc.
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
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
Sources for study design

  1. Main Study: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

    Timeframe: Up to Day 120 (7 days after each injection)

  2. Main Study: Number of Participants with Unsolicited Adverse Events (AEs)

    Timeframe: Up to Day 141 (28 days after each injection)

  3. Main Study: Number of Participants with Medically-Attended Adverse Events (MAAEs)

    Timeframe: Day 1 through Day 730

  4. 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

  5. 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)

  6. 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)

  1. 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

  2. Main Study (Parts A and B): Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies

    Timeframe: Baseline up to Month 12

  3. Main Study (Part C): GMT of Serum RSV Neutralizing Antibodies

    Timeframe: Baseline up to Month 12

  4. 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

  5. Main Study (Part C): GMC of Serum RSV F-Binding Antibodies

    Timeframe: Baseline up to Month 12

  6. Main Study: Geometric Mean Fold-Rise (GMFR) of Postbaseline/baseline Neutralizing Antibody Titers and Binding Antibody

    Timeframe: Month 12

  7. Main Study: Number of Participants with Vaccine-specific T-cell Responses Measured by Flow Cytometry

    Timeframe: Baseline up to Month 12

  8. 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)

  9. 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)

  10. 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)

  11. 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)

Sources for outcomes

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.

Sources for eligibility

  • 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
Sources for sites

  • 2022-502022-41-00
  • 2022-502022-41
Sources for references

Related records

Drugs (1)

Lead sponsors (1)