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

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ClinicalTrials.gov Identifier: NCT05743881
Recruitment Status : Active, not recruiting
First Posted : February 24, 2023
Last Update Posted : January 25, 2024
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Human Metapneumovirus Biological: mRNA-1345 Biological: mRNA-1365 Biological: Placebo Drug: Nimenrix Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 15, 2023
Estimated Primary Completion Date : July 30, 2026
Estimated Study Completion Date : July 30, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months)
Participants will receive mRNA-1345 vaccine by intramuscular (IM) injection on Days 1, 57 and 113.
 Biological: mRNA-1345
Sterile liquid for injection
Experimental: Part A: mRNA-1365, Dose 1 (Age Group: 8 to <24 months)
Participants will receive mRNA-1365 vaccine by IM injection on Days 1, 57 and 113.
 Biological: mRNA-1365
Sterile liquid for injection
Placebo Comparator: Part A: Placebo (Age Group: 8 to <24 months)
Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113.
 Biological: Placebo
0.9% sodium chloride (normal saline) solution for injection

Drug: Nimenrix
Solution for injection
Experimental: Part B: mRNA-1345, Dose 2 (Age Group: 5 to <8 months)
Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113.
 Biological: mRNA-1345
Sterile liquid for injection
Experimental: Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months)
Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113.
 Biological: mRNA-1365
Sterile liquid for injection
Experimental: Part B: mRNA-1345 Dose 1 (Age Group: 5 to <8 months)
Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113.
 Biological: mRNA-1345
Sterile liquid for injection
Experimental: Part B: mRNA-1365 Dose 1 (Age Group: 5 to <8 months)
Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113.
 Biological: mRNA-1365
Sterile liquid for injection
Placebo Comparator: Part B: Placebo (Age Group: 5 to <8 months)
Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113.
 Biological: Placebo
0.9% sodium chloride (normal saline) solution for injection

Drug: Nimenrix
Solution for injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 120 (7 days after each injection) ]
  2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 141 (28 days after each injection) ]
  3. Number of Participants with Medically-Attended Adverse Events (MAAEs) [ Time Frame: Day 1 through Day 730 ]
  4. Number of Participants with Adverse Event of Special Interests (AESIs), Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation [ Time Frame: Day 1 through Day 730 ]

Secondary Outcome Measures :
  1. Number of Participants with Respiratory Tract Illness (RTI), Lower Respiratory Tract Illness (LRTI), Severe LRTI, Very Severe LRTI, and Hospitalizations Associated with RSV [ Time Frame: Day 1 through Day 730 ]
  2. Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies [ Time Frame: Baseline up to Month 12 ]
  3. GMT of Serum RSV F- and hMPV F-Binding Antibodies [ Time Frame: Baseline up to Month 12 ]
  4. Geometric Mean Fold-Rise (GMFR) Postbaseline/baseline Neutralizing Antibody Titers [ Time Frame: Baseline up to Month 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant is 8 months to <24 months (Part A) or 5 months to <8 months (Part B) 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).

Exclusion Criteria:

  • Has a known history of symptomatic RSV 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 or hMPV infection within 14 days prior to administration of the first dose of IP (Part A and Part B).
  • 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 or hMPV infection or if the participant's mother received an investigational or approved vaccine for the prevention of RSV or hMPV 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.
  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05743881


Locations
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Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05743881    
Other Study ID Numbers: mRNA-1365-P101
2022-502022-41 ( EudraCT Number )
First Posted: February 24, 2023    Key Record Dates
Last Update Posted: January 25, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1345
mRNA-1365
RSV vaccine
hMPV vaccine