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Virus Therapy

RSV Vaccine for Infants and Toddlers (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 throughout the study (approximately 24 months)
Awards & highlights
Pivotal 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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study (approximately 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study (approximately 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Presence of adverse events of special interest (AESIs) throughout the study
Presence of medically attended adverse events MAAEs throughout the study
Presence of serious adverse events (SAEs) throughout the study
+12 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
416 Previous Clinical Trials
6,101,108 Total Patients Enrolled
~4200 spots leftby May 2026
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