Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL)

Primary Objective

To determine the safety, efficiency, and immunogenicity of an RSVt vaccine in infants and toddlers

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Description

Enrolling now through August 31st. This study is testing a nasal spray vaccine for RSV. Participants will need to attend 3-5 study visits, 2-4 blood draws, and e-diary entries to monitor for RSV-like illness. Participants will also need to return for any illness visits.

Details
Age

Child

Eligibility

Healthy children between 6 months and 22 months at enrollment. Born full term (>37 weeks) with no suspected immunodeficiencies.

Locations

Childrens Hospital Colorado

Principal Investigator
Photograph of Eric Simoes

Eric Simoes

Study ID

Protocol Number: 24-0668

More information available at ClinicalTrials.gov: NCT06252285

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