Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure
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ClinicalTrials.gov Identifier: NCT04144348 |
Recruitment Status :
Completed
First Posted : October 30, 2019
Last Update Posted : February 3, 2023
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Condition or disease | Intervention/treatment | Phase |
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Human Metapneumovirus and Human Parainfluenza Infection | Biological: mRNA-1653 Biological: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Parallel for the Adult Cohort, followed by Sequential Assignment for the Pediatric Cohort |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | Observer blind |
Primary Purpose: | Prevention |
Official Title: | A Phase 1b, Randomized, Observer-Blind, Placebo-Controlled, Dose Ranging Trial to Evaluate the Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine When Administered to Adults, and to Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure |
Actual Study Start Date : | November 4, 2019 |
Actual Primary Completion Date : | December 20, 2022 |
Actual Study Completion Date : | December 20, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: mRNA-1653, Adult participants
Participants will receive 1 of 2 doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.
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Biological: mRNA-1653
Sterile liquid for injection |
Experimental: mRNA-1653 Pediatric participants
Participants will receive 1 of 2 possible doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.
|
Biological: mRNA-1653
Sterile liquid for injection |
Placebo Comparator: Placebo, Adult participants
Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.
|
Biological: Placebo
Sterile liquid for injection
Other Name: saline |
Placebo Comparator: Placebo, Pediatric participants
Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.
|
Biological: Placebo
Sterile liquid for injection
Other Name: saline |
- Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to 7 days after each dose administration ]
- Proportion of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to 28 days after each dose administration ]
- Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs [ Time Frame: Up to 1 year after the last dose administration ]
- Geometric mean titer (GMT) of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies [ Time Frame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants ]
- Geometric Mean Ratio (GMR) of Post-Baseline/Baseline Titers of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies [ Time Frame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants ]
- Proportion of Participants with ≥2-Fold and ≥4-Fold Increases in Serum Anti-hMPV or Anti-PIV3 Neutralizing Antibody Titer from Baseline [ Time Frame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants ]

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.
Ages Eligible for Study: | 12 Months to 49 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Key Inclusion Criteria:
- Adults 18 to 49 years of age and children 12 to 59 months of age at the time of consent who, in the opinion of the Investigator, are in good health based on review of medical history and screening physical examination
- Adult participant or parent(s)/legal guardian(s) has provided written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol
- Screening laboratory values Grade ≤1
Specific inclusion criteria for adults 18 to 49 years of age:
- Body mass index (BMI) from ≥18 kg/m^2 and ≤35 kg/m^2
- Female participants must be either of non-childbearing potential or if of childbearing potential may be enrolled if the participant: 1) has a negative pregnancy test at Screening and on the day of vaccination, and 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination, and 3) has agreed to continue adequate contraception through 3 months following the last vaccination, and 4) is not currently breastfeeding
Specific inclusion criteria for children 12 to 59 months of age:
- Seropositive for both hMPV and PIV3 neutralizing antibody at Screening
- Has received routine immunizations appropriate for age per the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP)
- Current height and weight above the third percentile for age
Key Exclusion Criteria:
Adult and pediatric participants eligible for this study must not meet any of the following criteria:
- Acutely ill or febrile (temperature ≥38.0℃/100.4°F, regardless of route) on the day of the first vaccination
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- Receipt of, or plans for receipt of an inactivated vaccine(s) 14 days prior to though 14 days following each study injection or a live virus vaccine(s) within 28 days prior to, or plans to through 28 days following each study injection. The exception is any COVID-19 vaccine (regardless of type of vaccine) that becomes available to the participant during the study; efforts should be made to space study vaccinations and COVID-19 vaccinations by at least 7 and preferably 14 days, but COVID-19 vaccinations should not be delayed.
- Any chronic administration of an immunosuppressant or other immune modifying drug
- Prior administration of investigational agent using lipid nanoparticle formulations
- Donation of blood or blood products ≥450 mL within 28 days of the Screening visit (for the Adult Cohort)
- Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment
- Participated in an interventional clinical trial within 28 days prior to the day of enrollment, or plans to do so while enrolled in this trial
- Has a family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study

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): NCT04144348

Responsible Party: | ModernaTX, Inc. |
ClinicalTrials.gov Identifier: | NCT04144348 |
Other Study ID Numbers: |
mRNA-1653-P102 |
First Posted: | October 30, 2019 Key Record Dates |
Last Update Posted: | February 3, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
ModernaTX mRNA-1653 human metapneumovirus human parainfluenza human parainfluenza vaccine |
virus diseases RNA virus infections paramyxoviridae infections mononegavirales infections |
Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections Virus Diseases |