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mRNA Vaccine

mRNA Vaccines for RSV

Phase 1
Waitlist Available
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In general, do you consider your child to be in good health?
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to month 12
Awards & highlights

Study Summary

This trial tests the safety and effectiveness of two vaccines for RSV and hMPV in babies and toddlers.

Who is the study for?
This trial is for children aged 5 to less than 24 months who are generally healthy and have not had recent RSV or hMPV infections. They must be born full-term with a normal birth weight, without severe allergies to vaccine components, and haven't received RSV/hMPV prophylaxis.Check my eligibility
What is being tested?
The study tests two mRNA vaccines: mRNA-1365 against both RSV and hMPV, and mRNA-1345 against only RSV. Participants will receive the vaccines or placebo over several visits, with their safety and immune response monitored.See study design
What are the potential side effects?
Possible side effects include typical reactions at the injection site like pain or swelling, fever, fatigue, headache, muscle pain, chills. Severe allergic reactions are rare but possible due to vaccine ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Is your child generally healthy?

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Event of Special Interests (AESIs), Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation
Number of Participants with Medically-Attended Adverse Events (MAAEs)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
+1 more
Secondary outcome measures
GMT of Serum RSV F- and hMPV F-Binding Antibodies
Geometric Mean Fold-Rise (GMFR) Postbaseline/baseline Neutralizing Antibody Titers
Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies
+1 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months)Experimental Treatment1 Intervention
Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113.
Group II: Part B: mRNA-1365 Dose 1 (Age Group: 5 to <8 months)Experimental Treatment1 Intervention
Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113.
Group III: Part B: mRNA-1345, Dose 2 (Age Group: 5 to <8 months)Experimental Treatment1 Intervention
Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113.
Group IV: Part B: mRNA-1345 Dose 1 (Age Group: 5 to <8 months)Experimental Treatment1 Intervention
Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113.
Group V: Part A: mRNA-1365, Dose 1 (Age Group: 8 to <24 months)Experimental Treatment1 Intervention
Participants will receive mRNA-1365 vaccine by IM injection on Days 1, 57 and 113.
Group VI: Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months)Experimental Treatment1 Intervention
Participants will receive mRNA-1345 vaccine by intramuscular (IM) injection on Days 1, 57 and 113.
Group VII: Part B: Placebo (Age Group: 5 to <8 months)Placebo Group2 Interventions
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.
Group VIII: Part A: Placebo (Age Group: 8 to <24 months)Placebo Group2 Interventions
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.

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,377,915 Total Patients Enrolled

Media Library

mRNA-1345 (mRNA Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05743881 — Phase 1
Respiratory Syncytial Virus Research Study Groups: Part B: mRNA-1365 Dose 1 (Age Group: 5 to <8 months), Part B: mRNA-1345 Dose 1 (Age Group: 5 to <8 months), Part B: Placebo (Age Group: 5 to <8 months), Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months), Part A: mRNA-1365, Dose 1 (Age Group: 8 to <24 months), Part A: Placebo (Age Group: 8 to <24 months), Part B: mRNA-1345, Dose 2 (Age Group: 5 to <8 months), Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months)
Respiratory Syncytial Virus Clinical Trial 2023: mRNA-1345 Highlights & Side Effects. Trial Name: NCT05743881 — Phase 1
mRNA-1345 (mRNA Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05743881 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients being accepted for participation in this trial?

"This study is recruiting patients that fall between 5 and 24 Months of age."

Answered by AI

What is the maximum capacity of participants for this clinical trial?

"ModernaTX, Inc. is performing the trial from two sites; SEC Clinical Research in Andalusia and Los Angeles Children's Hospital. To complete this study a total of 210 eligible patients are needed for enrollment."

Answered by AI

Could you provide information regarding the current enrollment status of this research?

"According to the clinicaltrials.gov platform, this research opportunity is presently seeking participants. It was initiated on February 15th 2023 and subsequently updated on that same day."

Answered by AI

Does my profile fulfill the criteria to join this experimental research?

"This clinical trial is recruiting 210 young children with respiratory syncytial virus, aged between 5 months and 24 months. Qualified applicants must meet these criteria to partake in the study."

Answered by AI

To what extent is Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months) a hazard for human beings?

"Assessed on a scale of 1 to 3, the safety rating for Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months) is estimated at 1 due to its Phase 1 status - meaning that only minimal data exists in regard to both safety and efficacy."

Answered by AI

How many medical sites are currently administering this clinical trial?

"This clinical trial has recruited patients from 29 different locations, such as SEC Clinical Research in Andalusia, Los Angeles Children's Hospital in Los Angeles, and Meridian Clinical Research in Washington."

Answered by AI

Who else is applying?

What site did they apply to?
Dayton Clinical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
2023. "A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05743881.
~138 spots leftby Jul 2026
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