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Virus Therapy

Group 1 RSVt Vaccine for RSV vaccination (PEARL Trial)

Phase 3

Recruiting

Research Sponsored by Sanofi Pasteur, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 12 months post-dose 1 up to the start date of first occurrence of urtd associated with any rt-pcr confirmed rsv strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)

Awards & highlights

PEARL Trial Summary

"This trial will test a new vaccine for Respiratory Syncytial Virus in children between 6 months and 22 months old. The study will involve about 6300 children across multiple countries and centers

Who is the study for?

This trial is for healthy infants and toddlers aged 6 to less than 22 months, born at full term (≥37 weeks). It's designed to test a vaccine against Respiratory Syncytial Virus. Children with certain health conditions or who don't meet the age and birth criteria cannot participate.Check my eligibility

What is being tested?

The study compares an RSV toddler vaccine given through the nose to a placebo in about 6300 young children. Participants are randomly chosen to get either the real vaccine or placebo, and doctors observing won't know which one they got.See study design

What are the potential side effects?

Possible side effects of the RSVt vaccine may include nasal congestion, runny nose, coughing, or fever. These are common reactions after many vaccines but can vary from child to child.

PEARL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 minutes after each vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 minutes after each vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 minutes after each vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of lower respiratory tract disease (LRTD) (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2

Secondary outcome measures

Occurrence of ARD (during RSV Season 1) associated with an RT PCR confirmed RSV A or B strain > 21 days post-dose 2

Occurrence of ARD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1

Occurrence of ARD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, by baseline serostatus

+34 more

PEARL Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1 RSVt VaccineExperimental Treatment1 Intervention

Participants will receive 2 intranasal administrations of RSVt vaccine

Group II: Group 2 ControlPlacebo Group1 Intervention

Participants will receive 2 intranasal administrations of placebo

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor

407 Previous Clinical Trials

6,085,681 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 there any vacancies available for patients to participate in this trial?

"As per information on clinicaltrials.gov, this research project is presently in search of eligible participants. The trial's initial posting was dated February 6th, 2024, with the most recent edit made on March 15th, 2024."

Answered by AI

Is there an age limit that excludes individuals above 60 years old from participating in this medical study?

"Participants aged over 6 months and under 21 months are eligible for inclusion in the study."

Answered by AI

Which individuals meet the criteria for participation in this medical study?

"This study aims to enroll 6300 individuals who have received the RSV vaccine and are between 6 months and less than 22 months of age. To be eligible, participants must: - Be aged from their sixth month up to but not including their twenty-second month on the day of recruitment (from six months after birth until one day before turning twenty-two months), - Demonstrate good health following a medical assessment, with a complete medical history evaluation, - Have been born after completing at least thirty-seven weeks of pregnancy."

Answered by AI

How prevalent is the participation of medical centers in North America for this particular study?

"The research is conducted at Investigational Site Number 0320002 in San Miguel de Tucumán, Tucumán; Maximos OB/GYN in League City, Texas; and Investigational Site Number 3400001 in San Pedro Sula, Idaho. Additionally, the study extends to eight other undisclosed locations."

Answered by AI

Has the Group 1 RSVt Vaccine received official authorization from the FDA?

"According to our evaluation at Power, the safety rating for Group 1 RSVt Vaccine is graded as a 3 on the scale due to its Phase 3 trial status, indicating evidence of both efficacy and robust safety data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers

2024. "Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06252285.

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