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Cancer Vaccine

mRNA Vaccine for Respiratory Syncytial Virus

Q: Are senior citizens being taken into consideration for this experiment?

The minimal age for enrollment in this study is 2 and the maximum age accepted is 17.

Q: Who is eligible to partake in this medical experiment?

To be eligible for the clinical trial, prospective participants must have respiratory syncytial virus and fall within the 2 to 17 age bracket. In total, 340 individuals will take part in this study.

Q: Is it permissible for Cohort 1 (2 to <5 Years of Age) to partake in this FDA approved trial?

Our evaluation of Cohort 1 (2 to &#x3C;5 Years of Age) safety is a 2, as there has only been prior data demonstrating its security but not any efficacy.

Q: How many distinct locations are responsible for administering this research?

The trial is hosted in 21 different medical centres around the country, with Med-Care Research located in Miami and Accel Research Sites - Nona Pediatric Center stationed in Orlando being two of them. Seminole's own Accel Clinical also plays host to this research project, alongside 18 other sites.

Q: Is there an opportunity to join the experiment at this juncture?

This trial, which was initially posted on October 23rd 2023 and last updated on the 18th of October in the same year, is not actively seeking patients. Nevertheless, 105 other studies are recruiting new participants right now.

Phase 2

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

Cohort 1: 2 to <5 years of age, at the time the informed consent is signed.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 29, and month 6

Awards & highlights

Study Summary

This trial is testing the safety, effectiveness, and immune response of a new vaccine for children aged 2-18 to protect against RSV.

Who is the study for?

This trial is for children aged 2 to less than 18 years who are at high risk of RSV disease. It includes healthy kids or those with stable chronic conditions that increase RSV risk. Girls able to have babies must test negative for pregnancy, use birth control, and not be breastfeeding.Check my eligibility

What is being tested?

The study tests mRNA-1345, an experimental vaccine against Respiratory Syncytial Virus (RSV), compared to a placebo. The goal is to check the vaccine's safety and immune response in young participants to decide on doses for future trials.See study design

What are the potential side effects?

While specific side effects aren't listed here, typically vaccines can cause reactions where the shot was given, fever, fatigue, headaches or muscle pain. Serious side effects are rare but will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 2 and under 5 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 29, and month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 29, and month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 29, and month 6 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 AEs Leading to Discontinuation

Number of Participants With Adverse Events of Special Interest (AESIs)

Number of Participants With Medically Attended AEs (MAAEs)

+3 more

Secondary outcome measures

Geometric Mean Concentration (GMC) of Serum RSV Prefusion F Binding Antibody

Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations

Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (5 to <18 Years of Age)Experimental Treatment2 Interventions

Participants 5 to <18 years of age will receive either a single IM injection of mRNA-1345 or placebo on Day 1.

Group II: Cohort 1 (2 to <5 Years of Age)Experimental Treatment2 Interventions

Participants 2 to <5 years of age will receive either a single intramuscular (IM) injection of mRNA-1345 or placebo on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

107 Previous Clinical Trials

61,377,785 Total Patients Enrolled

Frequently Asked Questions

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

Are senior citizens being taken into consideration for this experiment?

"The minimal age for enrollment in this study is 2 and the maximum age accepted is 17."

Answered by AI

Who is eligible to partake in this medical experiment?

"To be eligible for the clinical trial, prospective participants must have respiratory syncytial virus and fall within the 2 to 17 age bracket. In total, 340 individuals will take part in this study."

Answered by AI

Is it permissible for Cohort 1 (2 to <5 Years of Age) to partake in this FDA approved trial?

"Our evaluation of Cohort 1 (2 to <5 Years of Age) safety is a 2, as there has only been prior data demonstrating its security but not any efficacy."

Answered by AI

How many distinct locations are responsible for administering this research?

"The trial is hosted in 21 different medical centres around the country, with Med-Care Research located in Miami and Accel Research Sites - Nona Pediatric Center stationed in Orlando being two of them. Seminole's own Accel Clinical also plays host to this research project, alongside 18 other sites."

Answered by AI

Is there an opportunity to join the experiment at this juncture?

"This trial, which was initially posted on October 23rd 2023 and last updated on the 18th of October in the same year, is not actively seeking patients. Nevertheless, 105 other studies are recruiting new participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus

2023. "A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06097299.

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