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

January 30, 2026 updated by: Sanofi Pasteur, a Sanofi Company

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)

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 Overview

Status

Terminated

Conditions

RSV Immunisation

Intervention / Treatment

Detailed Description

Study duration will be 24 months for each participant. The safety follow-up will start at inclusion and up to the end of the study.

Study Type

Interventional

Enrollment (Actual)

6300

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1426
    - Investigational Site Number : 0320001
  - Buenos Aires, Argentina, 1426
    - Investigational Site Number : 0320006
- Buenos Aires F.D.
  - Buenos Aires, Buenos Aires F.D., Argentina, C1425
    - Investigational Site Number : 0320007
- Córdoba Province
  - Río Cuarto, Córdoba Province, Argentina, X5800
    - Investigational Site Number : 0320003
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, S2013DTC
    - Investigational Site Number : 0320005
- Tucumán Province
  - SAN Miguel de Tucumã¡n, Tucumán Province, Argentina, T4000
    - Investigational Site Number : 0320002
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Investigational Site Number : 0320004
Brazil
- - São Paulo, Brazil, 04265-000
    - Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, 41680-020
    - Obras Sociais Irmã Dulce - Patamares- Site Number : 0760009
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30150-320
    - Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760001
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre- Site Number : 0760005
  - Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
    - Hospital Ernesto Dornelles- Site Number : 0760007
- São Paulo
  - Ribeirão Preto, São Paulo, Brazil, 14015-010
    - Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS- Site Number : 0760010
  - São José do Rio Preto, São Paulo, Brazil, 15090-000
    - Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006
  - Vila Clementino, São Paulo, Brazil, 04023-062
    - Escola Paulista De Medicina- Site Number : 0760002
Chile
- - Port Montt, Chile, 5480000
    - Investigational Site Number : 1520005
- Reg Metropolitana de Santiago
  - Santiago, Reg Metropolitana de Santiago, Chile, 8331143
    - Investigational Site Number : 1520004
  - Santiago, Reg Metropolitana de Santiago, Chile, 8380418
    - Investigational Site Number : 1520001
China
- - Jiangsu, China, 221699
    - Investigational Site Number : 1560009
Colombia
- - Acacías, Colombia, 507001
    - Investigational Site Number : 1700004
  - Chía, Colombia, 250001
    - Investigational Site Number : 1700002
  - Girardot, Colombia, 252431
    - Investigational Site Number : 1700003
Finland
- - Espoo, Finland, 02230
    - Investigational Site Number : 2460003
  - Helsinki, Finland, 00100
    - Investigational Site Number : 2460005
  - Jarvenpaa, Finland, 04400
    - Investigational Site Number : 2460008
  - Kokkola, Finland, 67100
    - Investigational Site Number : 2460004
  - Oulu, Finland, 90220
    - Investigational Site Number : 2460002
  - Seinäjoki, Finland, 60100
    - Investigational Site Number : 2460006
  - Tampere, Finland, 33100
    - Investigational Site Number : 2460009
  - Turku, Finland, 20520
    - Investigational Site Number : 2460001
Japan
- - Fukui, Japan, 910-0833
    - Investigational Site Number : 3920001
  - Fukui-shi, Japan, 910-0808
    - Investigational Site Number : 3920002
  - Fukuoka, Japan, 813-0036
    - Investigational Site Number : 3920004
  - Kagoshima, Japan, 890-0034
    - Investigational Site Number : 3920003
  - Kasuga-Shi, Japan, 816-0801
    - Investigational Site Number : 3920005
  - Osaka, Japan, 556-0005
    - Investigational Site Number : 3920009
- Fukuoka
  - Lizuka-shi, Fukuoka, Japan, 820-0040
    - Investigational Site Number : 3920008
- Hokkaido
  - Sapporo, Hokkaido, Japan, 063-0841
    - Investigational Site Number : 3920011
- Saitama
  - Kawagoe, Saitama, Japan, 350-0001
    - Investigational Site Number : 3920007
- Shizuoka
  - Shizuoka-Shi Aoi-Ku, Shizuoka, Japan, 420-0005
    - Investigational Site Number : 3920010
- Tokyo
  - Edogawa-Ku, Tokyo, Japan, 133-0056
    - Investigational Site Number : 3920006
Kenya
- - Butere, Kenya, 50101
    - Investigational Site Number : 4040007
  - Kisumu, Kenya, 40100
    - Investigational Site Number : 4040002
  - Kisumu, Kenya, 40100
    - Investigational Site Number : 4040003
  - Nairobi, Kenya, KENYA
    - Investigational Site Number : 4040006
  - Nairobi, Kenya, 00202
    - Investigational Site Number : 4040001
Mexico
- - Mexico City, Mexico, 14090
    - Investigational Site Number : 4840007
  - Veracruz, Mexico, 91900
    - Investigational Site Number : 4840004
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64060
    - Investigational Site Number : 4840008
Nepal
- Bagmati
  - Dhulikhel N.p, Bagmati, Nepal, 45210
    - Investigational Site Number : 5240003
  - Kathmandu, Bagmati, Nepal, 44600
    - Investigational Site Number : 5240001
- Bheri
  - Nepalgunj, Bheri, Nepal, 21900
    - Investigational Site Number : 5240002
Puerto Rico
- - Bayamón, Puerto Rico, 00961-7041
    - Clinical Research Investigator Group- Site Number : 6300001
  - Guayama, Puerto Rico, 00784
    - Clinical Research Puerto Rico (CRPR), Inc. - Guayama- Site Number : 6300005
  - San Juan, Puerto Rico, 00918
    - Caribbean Medical Research Center- Site Number : 6300003
  - San Juan, Puerto Rico, 00923
    - Hospital Pediatrico Universitario- Site Number : 6300002
South Africa
- - Brits, South Africa, 0250
    - Investigational Site Number : 7100007
  - City of Cape Town, South Africa, 7500
    - Investigational Site Number : 7100008
  - East London, South Africa, 5241
    - Investigational Site Number : 7100001
  - Johannesburg, South Africa, 2001
    - Investigational Site Number : 7100005
  - Johannesburg, South Africa, 2013
    - Investigational Site Number : 7100004
  - Johannesburg, South Africa, 2193
    - Investigational Site Number : 7100003
  - Paarl, South Africa, 7626
    - Investigational Site Number : 7100006
  - Pretoria, South Africa, 0122
    - Investigational Site Number : 7100002
  - Soshanguve, South Africa, 0152
    - Investigational Site Number : 7100009
Spain
- A Coruña [La Coruña]
  - Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
    - Investigational Site Number : 7240004
- Catalunya [Cataluña]
  - Barcelona, Catalunya [Cataluña], Spain, 08023
    - Investigational Site Number : 7240001
- Madrid
  - Móstoles, Madrid, Spain, 28938
    - Investigational Site Number : 7240003
- Navarre
  - Pamplona, Navarre, Spain, 31008
    - Investigational Site Number : 7240005
- Sevilla
  - Seville, Sevilla, Spain, 41013
    - Investigational Site Number : 7240002
Thailand
- - Bangkok, Thailand, 10400
    - Investigational Site Number : 7640002
  - Bangkok, Thailand, 10400
    - Investigational Site Number : 7640005
  - Bangkok, Thailand, 10700
    - Investigational Site Number : 7640004
  - Chiang Mai, Thailand, 50180
    - Investigational Site Number : 7640001
  - Hat Yai, Thailand, 90110
    - Investigational Site Number : 7640006
  - Khon Kaen, Thailand, 40002
    - Investigational Site Number : 7640003
United Kingdom
- - Bristol, United Kingdom, BS1 3NU
    - Investigational Site Number : 8260004
- Cornwall
  - Hayle, Cornwall, United Kingdom, TR27 5DT
    - Investigational Site Number : 8260003
- Devon
  - Exeter, Devon, United Kingdom, EX2 5DW
    - Investigational Site Number : 8260005
- Hampshire
  - Southampton, Hampshire, United Kingdom, SO16 6YD
    - Investigational Site Number : 8260007
United States
- Alabama
  - Birmingham, Alabama, United States, 35205-1628
    - Central Research Associates - Flourish - PPDS- Site Number : 8400009
  - Guntersville, Alabama, United States, 35976
    - Lakeview Clinical Research- Site Number : 8400024
- Arizona
  - Tucson, Arizona, United States, 85741-2306
    - Novak Clinical Research- Site Number : 8400069
- California
  - Madera, California, United States, 93637
    - Madera Family Medical Group- Site Number : 8400029
  - Tarzana, California, United States, 91356
    - Integrated Clinical Research- Site Number : 8400056
  - Victorville, California, United States, 92395
    - National Institute of Clinical Research - Victorville - Hesperia Road- Site Number : 8400040
- Florida
  - Brandon, Florida, United States, 33511
    - Moore Clinical Research - Brandon- Site Number : 8400065
  - Coconut Creek, Florida, United States, 33073
    - Invictus Clinical Research Group- Site Number : 8400035
  - Doral, Florida, United States, 33122-1088
    - Site Number : 8400031
  - Orlando, Florida, United States, 32829
    - Nona Pediatric Center- Site Number : 8400068
  - Tampa, Florida, United States, 33613
    - Teena Hughes Pediatrics- Site Number : 8400042
- Georgia
  - Atlanta, Georgia, United States, 30310
    - Morehouse School of Medicine - Atlanta- Site Number : 8400037
  - Atlanta, Georgia, United States, 30322-1014
    - Emory-Children's Center- Site Number : 8400001
  - Atlanta, Georgia, United States, 30328
    - Agile Clinical Research Trials- Site Number : 8400015
  - Chamblee, Georgia, United States, 30341
    - Tekton Research, LLC - 4961 Buford Hwy - Georgia - PPDS- Site Number : 8400064
  - Macon, Georgia, United States, 31210
    - Velocity Clinical Research - (Macon - Georgia) - PPDS- Site Number : 8400041
  - Savannah, Georgia, United States, 31405-5701
    - iResearch Savannah - CenExel - PPDS- Site Number : 8400032
- Idaho
  - Ammon, Idaho, United States, 83406
    - Medical Research Partners - Ammon- Site Number : 8400059
  - Idaho Falls, Idaho, United States, 83404
    - Clinical Research Prime- Site Number : 8400013
  - Idaho Falls, Idaho, United States, 83404
    - Leavitt Women's Healthcare- Site Number : 8400033
  - Idaho Falls, Idaho, United States, 83404
    - Snake River Research- Site Number : 8400046
- Michigan
  - Allen Park, Michigan, United States, 48101
    - Michigan Institute of Research- Site Number : 8400055
  - Dearborn Heights, Michigan, United States, 48127
    - Vida Clinical Studies - Dearborn Heights- Site Number : 8400072
  - Southfield, Michigan, United States, 48075
    - Great Lakes Research Institute- Site Number : 8400060
- Minnesota
  - Minneapolis, Minnesota, United States, 55402
    - Clinical Research Institute - Minneapolis- Site Number : 8400011
- Montana
  - Great Falls, Montana, United States, 59405
    - Boeson Research - Great Falls- Site Number : 8400008
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Velocity Clinical Research - Grand Island- Site Number : 8400017
  - Lincoln, Nebraska, United States, 68516
    - Be Well Clinical Studies - Lincoln- Site Number : 8400058
  - Norfolk, Nebraska, United States, 68701-2669
    - Velocity Clinical Research (Norfolk - Nebraska) - PPDS- Site Number : 8400038
  - Omaha, Nebraska, United States, 68114
    - Quality Clinical Research - Omaha - Regency Circle- Site Number : 8400016
  - Omaha, Nebraska, United States, 68134
    - Velocity Clinical Research - Omaha- Site Number : 8400054
- New York
  - The Bronx, New York, United States, 10456-2102
    - Prime Global Research, Inc.- Site Number : 8400043
- Ohio
  - Cincinnati, Ohio, United States, 45229
    - Cincinnati Children's Hospital Medical Center- Site Number : 8400063
  - South Euclid, Ohio, United States, 44121
    - Senders Pediatrics- Site Number : 8400006
- Oregon
  - Gresham, Oregon, United States, 97030
    - Cyn3rgy Research- Site Number : 8400014
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400036
  - North Charleston, South Carolina, United States, 29406
    - Palmetto Pediatrics- Site Number : 8400012
  - Simpsonville, South Carolina, United States, 29681
    - Parkside Pediatrics - Simpsonville- Site Number : 8400071
- Tennessee
  - Nashville, Tennessee, United States, 37203-2066
    - Clinical Research Associates Inc- Site Number : 8400005
- Texas
  - Beaumont, Texas, United States, 77706-3061
    - Tekton Research, LLC - Beaumont - PPDS- Site Number : 8400061
  - Del Rio, Texas, United States, 78840-3927
    - South Texas Urgent Care - Del Rio- Site Number : 8400062
  - Fort Worth, Texas, United States, 76104
    - Ventavia Research Group - Fort Worth- Site Number : 8400022
  - Houston, Texas, United States, 77057
    - Private Practice - Dr. Chinyere N. Awa- Site Number : 8400066
  - Houston, Texas, United States, 77065
    - DM Clinical Research - CyFair Clinical Research Center- Site Number : 8400044
  - League City, Texas, United States, 77573
    - Maximos Ob/Gyn- Site Number : 8400023
  - Richmond, Texas, United States, 77469
    - Pediatric Center - Richmond- Site Number : 8400019
  - San Antonio, Texas, United States, 78244
    - Tekton Research - FM78- Site Number : 8400067
- Utah
  - Layton, Utah, United States, 84041
    - Alliance for Multispecialty Research - Layton - North Robins Drive- Site Number : 8400030
  - Roy, Utah, United States, 84067
    - Wee Care Pediatrics - Roy- Site Number : 8400002
  - Syracuse, Utah, United States, 84075
    - Wee Care Pediatrics - Syracuse- Site Number : 8400004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: -Aged 6 months to < 22 months on the day of inclusion (means the day of the 6-month birthday to the day before the 22-month birthday)

Participants who are healthy as determined by medical evaluation including medical history
Born at full term of pregnancy (≥ 37 weeks)

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
History of medically diagnosed wheezing
Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
Probable or confirmed ongoing case of viral respiratory infection (including COVID-19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved.
Member of a household that contains an immunocompromised individual, including, but not limited to:
- a person who is HIV infected
- a person who has received chemotherapy within the 12 months prior to study enrollment
- a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents
- a person living with a solid organ or bone marrow transplant
Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigator's discretion
Participant's biological mother's previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding.
Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration:
- Any other intranasal live attenuated vaccine within the 28 days prior to and after Dose 1 study administration
- Unless given on the day of Dose 1 study administration, any other injectable live attenuated vaccines within the 28 days prior to and after. Concomitant receipt on the day of Dose 1 study administration is allowed.
Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment. Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration.
Receipt of immune globulins, blood or blood-derived products in the past 3 months
Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment
Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 RSVt Vaccine Participants will receive 2 intranasal administrations of RSVt vaccine	Biological: RSVt Vaccine Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal Other Names: 534
Placebo Comparator: Group 2 Control Participants will receive 2 intranasal administrations of placebo	Biological: Placebo Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of lower respiratory tract disease (LRTD) (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)	from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

VAD00004 Plain Language Results Summary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2024

Primary Completion (Actual)

December 4, 2025

Study Completion (Actual)

December 4, 2025

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

YM 534

Other Study ID Numbers

VAD00004 (Other Identifier: Sanofi Identifier)
2023-505762-29 (Registry Identifier: CTIS)
U1111-1280-7192 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Measure Description	Time Frame
Occurrence of upper respiratory tract disease (URTD) (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of URTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 2 up to the start date of first occurrence of URTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain leading to hospitalization > 21 days post-dose 2 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain leading to hospitalization, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain leading to hospitalization, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of severe LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of severe LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 2 up to the start date of first occurrence of severe LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of urgent care visits, associated with an episode of LRTD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of urgent care visit associated with an episode of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 2 up to the start date of first occurrence of urgent care visit associated with an episode of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of acute respiratory disease (ARD) (during RSV Season 1) associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of ARD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 2 up to the start date of first occurrence of ARD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of hospitalizations, associated with an episode of ARD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post dose 2 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of hospitalizations associated with an episode of ARD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 2 up to the start date of first occurrence of hospitalizations associated with an episode of ARD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of urgent care visits, associated with an episode of ARD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of urgent care visit associated with an episode of ARD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1		from 22 days post-dose 2 up to the start date of first occurrence of urgent care visit associated with an episode of ARD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1
Occurrence of LRTD (during RSV Season 1) associated with an RT-PCR confirmed RSV A or B strain > 21 days post-dose 2 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with an RT PCR confirmed RSV A or B, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with an RT PCR confirmed RSV A or B, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of URTD (during RSV Season 1) associated with an RT-PCR confirmed RSV A or B strain > 21 days post-dose 2 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of URTD associated with an RT-PCR confirmed RSV A or B, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 2 up to the start date of first occurrence of URTD associated with an RT-PCR confirmed RSV A or B, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of ARD (during RSV Season 1) associated with an RT PCR confirmed RSV A or B strain > 21 days post-dose 2 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of ARD associated with an RT-PCR confirmed RSV A or B, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 2 up to the start date of first occurrence of ARD associated with an RT-PCR confirmed RSV A or B, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1 Time Frame: from 22 days post-dose 1 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 1 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1 Time Frame: from 22 days 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 RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days 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 RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of ARD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1 Time Frame: from 22 days post-dose 1 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 1 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, in RSV-exposed participants Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1		from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1
Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, by baseline serostatus Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of URTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 2 up to the start date of first occurrence of URTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months 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 Time Frame: from 22 days post-dose 2 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)		from 22 days post-dose 2 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Occurrence of LRTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain Time Frame: from 12 months post-dose 1 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)		from 12 months post-dose 1 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)
Occurrence of URTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain Time Frame: 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)		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)
Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain Time Frame: from 12 months post-dose 1 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1		from 12 months post-dose 1 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1
Occurrence of LRTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus Time Frame: from 12 months post-dose 1 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)		from 12 months post-dose 1 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)
Occurrence of URTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus Time Frame: 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)		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)
Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus Time Frame: from 12 months post-dose 1 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)		from 12 months post-dose 1 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)
Presence of solicited administration site reactions within 21 days after each vaccination Time Frame: Within 21 days after each vaccination	Number of participants experiencing solicited site reactions	Within 21 days after each vaccination
Presence of solicited systemic reactions within 21 days after each vaccination Time Frame: Within 21 days after each vaccination	Number of participants experiencing solicited systemic reactions	Within 21 days after each vaccination
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination Time Frame: Within 30 minutes after each vaccination	Number of participants experiencing immediate unsolicited systemic AES	Within 30 minutes after each vaccination
Presence of unsolicited AEs within 28 days after each vaccination Time Frame: Within 28 days after each vaccination	Number of participants experiencing unsolicited AES	Within 28 days after each vaccination
Presence of medically attended adverse events MAAEs throughout the study Time Frame: Throughout the study (approximately 24 months)	Number of participants experiencing MAAEs	Throughout the study (approximately 24 months)
Presence of serious adverse events (SAEs) throughout the study Time Frame: Throughout the study (approximately 24 months)	Number of participants experiencing SAEs	Throughout the study (approximately 24 months)
Presence of adverse events of special interest (AESIs) throughout the study Time Frame: Throughout the study (approximately 24 months)	Number of participants experiencing AESIs	Throughout the study (approximately 24 months)
RSV A serum neutralizing antibody titers at D01 Time Frame: Day 01	Antibody titers are expressed as GMTs at baseline	Day 01
RSV B serum neutralizing antibody titers at D01 Time Frame: Day 01	Antibody titers are expressed as GMTs at baseline	Day 01
RSV A serum neutralizing antibody titers at 28 days post-dose 2 Time Frame: 28 days post-dose 2	Antibody titers are expressed as GMTs at post-baseline	28 days post-dose 2
RSV B serum neutralizing antibody titers at 28 days post-dose 2 Time Frame: 28 days post-dose 2	Antibody titers are expressed as GMTs post-baseline	28 days post-dose 2
RSV serum anti-F Immunoglobulin A (IgA) Electrochemiluminescence (ECL) antibody titers at D01 Time Frame: Day 01	Antibody titers are expressed as GMTs at baseline	Day 01
RSV serum anti-F IgG ECL antibody titers at D01 Time Frame: Day 01	Antibody titers are expressed as GMTs at baseline	Day 01
RSV serum anti-F Immunoglobulin A (IgA) ECL antibody titers at 28 days post-dose 2 Time Frame: 28 Days post-dose 2	Antibody titers are expressed as GMTs post-baseline	28 Days post-dose 2
RSV serum anti-F IgG ECL antibody titers at 28 days post-dose 2 Time Frame: 28 Days post-dose 2	Antibody titers are expressed as GMTs post-baseline	28 Days post-dose 2

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

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)

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Accepts Healthy Volunteers

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Primary Outcome Measures

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Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

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