Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Public ClinicalTrials.gov record NCT06252285. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to \< 22 months of age. The purpose of the study is to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus Toddler (RSVt) vaccine administered by intranasal route compared to placebo. Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo. Study duration will be 24 months for each participant. The safety follow-up will start after the first vaccination and up to the end of the study.
Study identification
- NCT ID
- NCT06252285
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 6,300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 21 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 6, 2024 (Actual)
- Primary completion
- Dec 4, 2025 (Actual)
- Completion
- Dec 4, 2025 (Actual)
- Last update posted
- Feb 3, 2026
2024 – 2025
United States locations
- U.S. sites
- 50
- U.S. states
- 17
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Research Associates - Flourish - PPDS- Site Number : 8400009 | Birmingham | Alabama | 35205-1628 | — |
| Lakeview Clinical Research- Site Number : 8400024 | Guntersville | Alabama | 35976 | — |
| Novak Clinical Research- Site Number : 8400069 | Tucson | Arizona | 85741-2306 | — |
| Madera Family Medical Group- Site Number : 8400029 | Madera | California | 93637 | — |
| Integrated Clinical Research- Site Number : 8400056 | Tarzana | California | 91356 | — |
| National Institute of Clinical Research - Victorville - Hesperia Road- Site Number : 8400040 | Victorville | California | 92395 | — |
| Moore Clinical Research - Brandon- Site Number : 8400065 | Brandon | Florida | 33511 | — |
| Invictus Clinical Research Group- Site Number : 8400035 | Coconut Creek | Florida | 33073 | — |
| Site Number : 8400031 | Doral | Florida | 33122-1088 | — |
| Nona Pediatric Center- Site Number : 8400068 | Orlando | Florida | 32829 | — |
| Teena Hughes Pediatrics- Site Number : 8400042 | Tampa | Florida | 33613 | — |
| Morehouse School of Medicine - Atlanta- Site Number : 8400037 | Atlanta | Georgia | 30310 | — |
| Emory-Children's Center- Site Number : 8400001 | Atlanta | Georgia | 30322-1014 | — |
| Agile Clinical Research Trials- Site Number : 8400015 | Atlanta | Georgia | 30328 | — |
| Tekton Research, LLC - 4961 Buford Hwy - Georgia - PPDS- Site Number : 8400064 | Chamblee | Georgia | 30341 | — |
| Velocity Clinical Research - (Macon - Georgia) - PPDS- Site Number : 8400041 | Macon | Georgia | 31210 | — |
| iResearch Savannah - CenExel - PPDS- Site Number : 8400032 | Savannah | Georgia | 31405-5701 | — |
| Medical Research Partners - Ammon- Site Number : 8400059 | Ammon | Idaho | 83406 | — |
| Clinical Research Prime- Site Number : 8400013 | Idaho Falls | Idaho | 83404 | — |
| Leavitt Women's Healthcare- Site Number : 8400033 | Idaho Falls | Idaho | 83404 | — |
| Snake River Research- Site Number : 8400046 | Idaho Falls | Idaho | 83404 | — |
| Michigan Institute of Research- Site Number : 8400055 | Allen Park | Michigan | 48101 | — |
| Vida Clinical Studies - Dearborn Heights- Site Number : 8400072 | Dearborn Heights | Michigan | 48127 | — |
| Great Lakes Research Institute- Site Number : 8400060 | Southfield | Michigan | 48075 | — |
| Clinical Research Institute - Minneapolis- Site Number : 8400011 | Minneapolis | Minnesota | 55402 | — |
| Boeson Research - Great Falls- Site Number : 8400008 | Great Falls | Montana | 59405 | — |
| Velocity Clinical Research - Grand Island- Site Number : 8400017 | Grand Island | Nebraska | 68803 | — |
| Be Well Clinical Studies - Lincoln- Site Number : 8400058 | Lincoln | Nebraska | 68516 | — |
| Velocity Clinical Research (Norfolk - Nebraska) - PPDS- Site Number : 8400038 | Norfolk | Nebraska | 68701-2669 | — |
| Quality Clinical Research - Omaha - Regency Circle- Site Number : 8400016 | Omaha | Nebraska | 68114 | — |
| Velocity Clinical Research - Omaha- Site Number : 8400054 | Omaha | Nebraska | 68134 | — |
| Prime Global Research, Inc.- Site Number : 8400043 | The Bronx | New York | 10456-2102 | — |
| Cincinnati Children's Hospital Medical Center- Site Number : 8400063 | Cincinnati | Ohio | 45229 | — |
| Senders Pediatrics- Site Number : 8400006 | South Euclid | Ohio | 44121 | — |
| Cyn3rgy Research- Site Number : 8400014 | Gresham | Oregon | 97030 | — |
| Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400036 | Charleston | South Carolina | 29425 | — |
| Palmetto Pediatrics- Site Number : 8400012 | North Charleston | South Carolina | 29406 | — |
| Parkside Pediatrics - Simpsonville- Site Number : 8400071 | Simpsonville | South Carolina | 29681 | — |
| Clinical Research Associates Inc- Site Number : 8400005 | Nashville | Tennessee | 37203-2066 | — |
| Tekton Research, LLC - Beaumont - PPDS- Site Number : 8400061 | Beaumont | Texas | 77706-3061 | — |
| South Texas Urgent Care - Del Rio- Site Number : 8400062 | Del Rio | Texas | 78840-3927 | — |
| Ventavia Research Group - Fort Worth- Site Number : 8400022 | Fort Worth | Texas | 76104 | — |
| Private Practice - Dr. Chinyere N. Awa- Site Number : 8400066 | Houston | Texas | 77057 | — |
| DM Clinical Research - CyFair Clinical Research Center- Site Number : 8400044 | Houston | Texas | 77065 | — |
| Maximos Ob/Gyn- Site Number : 8400023 | League City | Texas | 77573 | — |
| Pediatric Center - Richmond- Site Number : 8400019 | Richmond | Texas | 77469 | — |
| Tekton Research - FM78- Site Number : 8400067 | San Antonio | Texas | 78244 | — |
| Alliance for Multispecialty Research - Layton - North Robins Drive- Site Number : 8400030 | Layton | Utah | 84041 | — |
| Wee Care Pediatrics - Roy- Site Number : 8400002 | Roy | Utah | 84067 | — |
| Wee Care Pediatrics - Syracuse- Site Number : 8400004 | Syracuse | Utah | 84075 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 80 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06252285, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 3, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06252285 live on ClinicalTrials.gov.