Verified

Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months) for Respiratory Syncytial Virus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
DM Clinical Research - Houston, Houston, TXVerifiedRespiratory Syncytial Virus+1 MoremRNA-1365 - Biological
Eligibility
5 - 24
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Respiratory Syncytial Virus
  • Human Metapneumovirus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: Baseline up to Month 12

Month 12
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
Day 477
Number of Participants with Respiratory Tract Illness (RTI), Lower Respiratory Tract Illness (LRTI), Severe LRTI, Very Severe LRTI, and Hospitalizations Associated with RSV
Day 730
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)
Day 120
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Day 141
Number of Participants with Unsolicited Adverse Events (AEs)

Trial Safety

Safety Progress

1 of 3

Trial Design

8 Treatment Groups

Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months)
1 of 8
Part B: mRNA-1345 Dose 1 (Age Group: 5 to <8 months)
1 of 8
Part B: mRNA-1345, Dose 2 (Age Group: 5 to <8 months)
1 of 8
Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months)
1 of 8
Part A: mRNA-1365, Dose 1 (Age Group: 8 to <24 months)
1 of 8
Part B: mRNA-1365 Dose 1 (Age Group: 5 to <8 months)
1 of 8
Part A: Placebo (Age Group: 8 to <24 months)
1 of 8
Part B: Placebo (Age Group: 5 to <8 months)
1 of 8

Experimental Treatment

Non-Treatment Group

210 Total Participants · 8 Treatment Groups

Primary Treatment: Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months) · Has Placebo Group · Phase 1

Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months)
Biological
Experimental Group · 1 Intervention: mRNA-1365 · Intervention Types: Biological
Part B: mRNA-1345 Dose 1 (Age Group: 5 to <8 months)
Biological
Experimental Group · 1 Intervention: mRNA-1345 · Intervention Types: Biological
Part B: mRNA-1345, Dose 2 (Age Group: 5 to <8 months)
Biological
Experimental Group · 1 Intervention: mRNA-1345 · Intervention Types: Biological
Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months)
Biological
Experimental Group · 1 Intervention: mRNA-1345 · Intervention Types: Biological
Part A: mRNA-1365, Dose 1 (Age Group: 8 to <24 months)
Biological
Experimental Group · 1 Intervention: mRNA-1365 · Intervention Types: Biological
Part B: mRNA-1365 Dose 1 (Age Group: 5 to <8 months)
Biological
Experimental Group · 1 Intervention: mRNA-1365 · Intervention Types: Biological
Part A: Placebo (Age Group: 8 to <24 months)PlaceboComparator Group · 2 Interventions: Placebo, Nimenrix · Intervention Types: Biological, Drug
Part B: Placebo (Age Group: 5 to <8 months)PlaceboComparator Group · 2 Interventions: Placebo, Nimenrix · Intervention Types: Biological, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to month 12

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
72 Previous Clinical Trials
50,290,813 Total Patients Enrolled

Eligibility Criteria

Age 5 - 24 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Is your child between 8 and 23 months old?
Is your child generally healthy?
Can you commit to attending 9 in-person visits and taking part in 15 phone calls over a period of around 16 months?

Frequently Asked Questions

Are geriatric patients being accepted for participation in this trial?

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.