AzTrials
AzTrials

RSV ImmunisationPhase 3PEARLNCT06252285

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

A Phase 3 study testing RSVt Vaccine in people with RSV Immunisation, run by Sanofi Pasteur, a Sanofi Company at 130 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 21 monthsHealthy volunteers can take part
Conditions the study is for
RSV Immunisation
What is being tested?
RSVt Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,300 participants
Where
130 sitesin 16 countries
Study dates
6 Feb 2024to 4 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 21 months
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Trial locations and contacts

130 sites in 16 countries.

130 sites in 16 countries

United States50 sites

  • Michigan Institute of Research- Site Number : 8400055

    Allen Park, Michigan, 48101

  • Medical Research Partners - Ammon- Site Number : 8400059

    Ammon, Idaho, 83406

  • 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 - Beaumont - PPDS- Site Number : 8400061

    Beaumont, Texas, 77706-3061

  • Central Research Associates - Flourish - PPDS- Site Number : 8400009

    Birmingham, Alabama, 35205-1628

  • Moore Clinical Research - Brandon- Site Number : 8400065

    Brandon, Florida, 33511

  • Tekton Research, LLC - 4961 Buford Hwy - Georgia - PPDS- Site Number : 8400064

    Chamblee, Georgia, 30341

  • Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400036

    Charleston, South Carolina, 29425

  • Cincinnati Children's Hospital Medical Center- Site Number : 8400063

    Cincinnati, Ohio, 45229

  • Invictus Clinical Research Group- Site Number : 8400035

    Coconut Creek, Florida, 33073

  • Vida Clinical Studies - Dearborn Heights- Site Number : 8400072

    Dearborn Heights, Michigan, 48127

  • South Texas Urgent Care - Del Rio- Site Number : 8400062

    Del Rio, Texas, 78840-3927

  • Site Number : 8400031

    Doral, Florida, 33122-1088

  • Ventavia Research Group - Fort Worth- Site Number : 8400022

    Fort Worth, Texas, 76104

  • Velocity Clinical Research - Grand Island- Site Number : 8400017

    Grand Island, Nebraska, 68803

  • Boeson Research - Great Falls- Site Number : 8400008

    Great Falls, Montana, 59405

  • Cyn3rgy Research- Site Number : 8400014

    Gresham, Oregon, 97030

  • Lakeview Clinical Research- Site Number : 8400024

    Guntersville, Alabama, 35976

  • 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

  • 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

  • Alliance for Multispecialty Research - Layton - North Robins Drive- Site Number : 8400030

    Layton, Utah, 84041

  • Maximos Ob/Gyn- Site Number : 8400023

    League City, Texas, 77573

  • Be Well Clinical Studies - Lincoln- Site Number : 8400058

    Lincoln, Nebraska, 68516

  • Velocity Clinical Research - (Macon - Georgia) - PPDS- Site Number : 8400041

    Macon, Georgia, 31210

  • Madera Family Medical Group- Site Number : 8400029

    Madera, California, 93637

  • Clinical Research Institute - Minneapolis- Site Number : 8400011

    Minneapolis, Minnesota, 55402

  • Clinical Research Associates Inc- Site Number : 8400005

    Nashville, Tennessee, 37203-2066

  • Velocity Clinical Research (Norfolk - Nebraska) - PPDS- Site Number : 8400038

    Norfolk, Nebraska, 68701-2669

  • Palmetto Pediatrics- Site Number : 8400012

    North Charleston, South Carolina, 29406

  • Quality Clinical Research - Omaha - Regency Circle- Site Number : 8400016

    Omaha, Nebraska, 68114

  • Velocity Clinical Research - Omaha- Site Number : 8400054

    Omaha, Nebraska, 68134

  • Nona Pediatric Center- Site Number : 8400068

    Orlando, Florida, 32829

  • Pediatric Center - Richmond- Site Number : 8400019

    Richmond, Texas, 77469

  • Wee Care Pediatrics - Roy- Site Number : 8400002

    Roy, Utah, 84067

  • Tekton Research - FM78- Site Number : 8400067

    San Antonio, Texas, 78244

  • iResearch Savannah - CenExel - PPDS- Site Number : 8400032

    Savannah, Georgia, 31405-5701

  • Parkside Pediatrics - Simpsonville- Site Number : 8400071

    Simpsonville, South Carolina, 29681

  • Senders Pediatrics- Site Number : 8400006

    South Euclid, Ohio, 44121

  • Great Lakes Research Institute- Site Number : 8400060

    Southfield, Michigan, 48075

  • Wee Care Pediatrics - Syracuse- Site Number : 8400004

    Syracuse, Utah, 84075

  • Teena Hughes Pediatrics- Site Number : 8400042

    Tampa, Florida, 33613

  • Integrated Clinical Research- Site Number : 8400056

    Tarzana, California, 91356

  • Prime Global Research, Inc.- Site Number : 8400043

    The Bronx, New York, 10456-2102

  • Novak Clinical Research- Site Number : 8400069

    Tucson, Arizona, 85741-2306

  • National Institute of Clinical Research - Victorville - Hesperia Road- Site Number : 8400040

    Victorville, California, 92395

Other trials in United States

Japan11 sites

  • Investigational Site Number : 3920006

    Edogawa-Ku, Tokyo, 133-0056

  • Investigational Site Number : 3920001

    Fukui, 910-0833

  • Investigational Site Number : 3920002

    Fukui-shi, 910-0808

  • Investigational Site Number : 3920004

    Fukuoka, 813-0036

  • Investigational Site Number : 3920003

    Kagoshima, 890-0034

  • Investigational Site Number : 3920005

    Kasuga-Shi, 816-0801

  • Investigational Site Number : 3920007

    Kawagoe, Saitama, 350-0001

  • Investigational Site Number : 3920008

    Lizuka-shi, Fukuoka, 820-0040

  • Investigational Site Number : 3920009

    Osaka, 556-0005

  • Investigational Site Number : 3920011

    Sapporo, Hokkaido, 063-0841

  • Investigational Site Number : 3920010

    Shizuoka-Shi Aoi-Ku, Shizuoka, 420-0005

Other trials in Japan

South Africa9 sites

  • Investigational Site Number : 7100007

    Brits, 0250

  • Investigational Site Number : 7100008

    City of Cape Town, 7500

  • Investigational Site Number : 7100001

    East London, 5241

  • Investigational Site Number : 7100005

    Johannesburg, 2001

  • Investigational Site Number : 7100004

    Johannesburg, 2013

  • Investigational Site Number : 7100003

    Johannesburg, 2193

  • Investigational Site Number : 7100006

    Paarl, 7626

  • Investigational Site Number : 7100002

    Pretoria, 0122

  • Investigational Site Number : 7100009

    Soshanguve, 0152

Other trials in South Africa

Brazil8 sites

  • Freire Pesquisa Clínica - Belo Horizonte - Rua Piauí- Site Number : 0760001

    Belo Horizonte, Minas Gerais, 30150-320

  • Hospital de Clinicas de Porto Alegre- Site Number : 0760005

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Ernesto Dornelles- Site Number : 0760007

    Porto Alegre, Rio Grande do Sul, 90160-093

  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS- Site Number : 0760010

    Ribeirão Preto, São Paulo, 14015-010

  • Obras Sociais Irmã Dulce - Patamares- Site Number : 0760009

    Salvador, Estado de Bahia, 41680-020

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006

    São José do Rio Preto, São Paulo, 15090-000

  • Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004

    São Paulo, 04265-000

  • Escola Paulista De Medicina- Site Number : 0760002

    Vila Clementino, São Paulo, 04023-062

Other trials in Brazil

Finland8 sites

  • Investigational Site Number : 2460003

    Espoo, 02230

  • Investigational Site Number : 2460005

    Helsinki, 00100

  • Investigational Site Number : 2460008

    Jarvenpaa, 04400

  • Investigational Site Number : 2460004

    Kokkola, 67100

  • Investigational Site Number : 2460002

    Oulu, 90220

  • Investigational Site Number : 2460006

    Seinäjoki, 60100

  • Investigational Site Number : 2460009

    Tampere, 33100

  • Investigational Site Number : 2460001

    Turku, 20520

Other trials in Finland

Argentina7 sites

  • Investigational Site Number : 0320007

    Buenos Aires, Buenos Aires F.D., C1425

  • Investigational Site Number : 0320001

    Buenos Aires, 1426

  • Investigational Site Number : 0320006

    Buenos Aires, 1426

  • Investigational Site Number : 0320003

    Río Cuarto, Córdoba Province, X5800

  • Investigational Site Number : 0320005

    Rosario, Santa Fe Province, S2013DTC

  • Investigational Site Number : 0320002

    SAN Miguel de Tucumã¡n, Tucumán Province, T4000

  • Investigational Site Number : 0320004

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Thailand6 sites

  • Investigational Site Number : 7640002

    Bangkok, 10400

  • Investigational Site Number : 7640005

    Bangkok, 10400

  • Investigational Site Number : 7640004

    Bangkok, 10700

  • Investigational Site Number : 7640001

    Chiang Mai, 50180

  • Investigational Site Number : 7640006

    Hat Yai, 90110

  • Investigational Site Number : 7640003

    Khon Kaen, 40002

Other trials in Thailand

Kenya5 sites

  • Investigational Site Number : 4040007

    Butere, 50101

  • Investigational Site Number : 4040002

    Kisumu, 40100

  • Investigational Site Number : 4040003

    Kisumu, 40100

  • Investigational Site Number : 4040001

    Nairobi, 00202

  • Investigational Site Number : 4040006

    Nairobi, KENYA

Other trials in Kenya

Spain5 sites

  • Investigational Site Number : 7240001

    Barcelona, Catalunya [Cataluña], 08023

  • Investigational Site Number : 7240003

    Móstoles, Madrid, 28938

  • Investigational Site Number : 7240005

    Pamplona, Navarre, 31008

  • Investigational Site Number : 7240004

    Santiago de Compostela, A Coruña [La Coruña], 15706

  • Investigational Site Number : 7240002

    Seville, Sevilla, 41013

Other trials in Spain

Puerto Rico4 sites

  • Clinical Research Investigator Group- Site Number : 6300001

    Bayamón, 00961-7041

  • Clinical Research Puerto Rico (CRPR), Inc. - Guayama- Site Number : 6300005

    Guayama, 00784

  • Caribbean Medical Research Center- Site Number : 6300003

    San Juan, 00918

  • Hospital Pediatrico Universitario- Site Number : 6300002

    San Juan, 00923

Other trials in Puerto Rico

United Kingdom4 sites

  • Investigational Site Number : 8260004

    Bristol, BS1 3NU

  • Investigational Site Number : 8260005

    Exeter, Devon, EX2 5DW

  • Investigational Site Number : 8260003

    Hayle, Cornwall, TR27 5DT

  • Investigational Site Number : 8260007

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Chile3 sites

  • Investigational Site Number : 1520005

    Port Montt, 5480000

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 8331143

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8380418

Other trials in Chile

Colombia3 sites

  • Investigational Site Number : 1700004

    Acacías, 507001

  • Investigational Site Number : 1700002

    Chía, 250001

  • Investigational Site Number : 1700003

    Girardot, 252431

Other trials in Colombia

Mexico3 sites

  • Investigational Site Number : 4840007

    Mexico City, 14090

  • Investigational Site Number : 4840008

    Monterrey, Nuevo León, 64060

  • Investigational Site Number : 4840004

    Veracruz, 91900

Other trials in Mexico

Nepal3 sites

  • Investigational Site Number : 5240003

    Dhulikhel N.p, Bagmati, 45210

  • Investigational Site Number : 5240001

    Kathmandu, Bagmati, 44600

  • Investigational Site Number : 5240002

    Nepalgunj, Bheri, 21900

Other trials in Nepal

China1 site

  • Investigational Site Number : 1560009

    Jiangsu, 221699

Other trials in China

About this study

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)

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.

Read the 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.

Being tested
RSVt Vaccine, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSVt VaccineBiological

    Also called 534

    Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal

  • PlaceboBiological

    Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal

Study groups in NCT06252285
Study groupRoleWhat they receive
Group 1 RSVt VaccineExperimentalParticipants will receive 2 intranasal administrations of RSVt vaccine
Receives: Biological: RSVt Vaccine
Group 2 ControlPlacebo comparatorParticipants will receive 2 intranasal administrations of placebo
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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 outcomes (37)

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

    Measured: 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)

  2. Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain leading to hospitalization > 21 days post-dose 2

    Measured: 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)

  3. Occurrence of severe LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2

    Measured: 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)

  4. 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

    Measured: 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)

  5. Occurrence of acute respiratory disease (ARD) (during RSV Season 1) associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2

    Measured: 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)

  6. 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

    Measured: 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)

  7. 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

    Measured: 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

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

    Measured: 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)

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

    Measured: 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)

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

    Measured: 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)

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

    Measured: 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)

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

    Measured: 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)

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

    Measured: 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)

  14. Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, in RSV-exposed participants

    Measured: 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

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

    Measured: 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)

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

    Measured: 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)

  17. Occurrence of LRTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain

    Measured: 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)

  18. Occurrence of URTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain

    Measured: 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)

  19. Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain

    Measured: 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

  20. Occurrence of LRTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus

    Measured: 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)

  21. Occurrence of URTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus

    Measured: 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)

  22. Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus

    Measured: 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)

  23. Presence of solicited administration site reactions within 21 days after each vaccination

    Number of participants experiencing solicited site reactions

    Measured: Within 21 days after each vaccination

  24. Presence of solicited systemic reactions within 21 days after each vaccination

    Number of participants experiencing solicited systemic reactions

    Measured: Within 21 days after each vaccination

  25. Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination

    Number of participants experiencing immediate unsolicited systemic AES

    Measured: Within 30 minutes after each vaccination

  26. Presence of unsolicited AEs within 28 days after each vaccination

    Number of participants experiencing unsolicited AES

    Measured: Within 28 days after each vaccination

  27. Presence of medically attended adverse events MAAEs throughout the study

    Number of participants experiencing MAAEs

    Measured: Throughout the study (approximately 24 months)

  28. Presence of serious adverse events (SAEs) throughout the study

    Number of participants experiencing SAEs

    Measured: Throughout the study (approximately 24 months)

  29. Presence of adverse events of special interest (AESIs) throughout the study

    Number of participants experiencing AESIs

    Measured: Throughout the study (approximately 24 months)

  30. RSV A serum neutralizing antibody titers at D01

    Antibody titers are expressed as GMTs at baseline

    Measured: Day 01

  31. RSV B serum neutralizing antibody titers at D01

    Antibody titers are expressed as GMTs at baseline

    Measured: Day 01

  32. RSV A serum neutralizing antibody titers at 28 days post-dose 2

    Antibody titers are expressed as GMTs at post-baseline

    Measured: 28 days post-dose 2

  33. RSV B serum neutralizing antibody titers at 28 days post-dose 2

    Antibody titers are expressed as GMTs post-baseline

    Measured: 28 days post-dose 2

  34. RSV serum anti-F Immunoglobulin A (IgA) Electrochemiluminescence (ECL) antibody titers at D01

    Antibody titers are expressed as GMTs at baseline

    Measured: Day 01

  35. RSV serum anti-F IgG ECL antibody titers at D01

    Antibody titers are expressed as GMTs at baseline

    Measured: Day 01

  36. RSV serum anti-F Immunoglobulin A (IgA) ECL antibody titers at 28 days post-dose 2

    Antibody titers are expressed as GMTs post-baseline

    Measured: 28 Days post-dose 2

  37. RSV serum anti-F IgG ECL antibody titers at 28 days post-dose 2

    Antibody titers are expressed as GMTs post-baseline

    Measured: 28 Days post-dose 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2024
  2. Study start6 Feb 2024
  3. Primary completion4 Dec 2025
  4. Study completion4 Dec 2025

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
6,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06252285
Sponsor's protocol ID
VAD00004
Other IDs
2023-505762-29, U1111-1280-7192, VAD00004, 2023
Acronym
PEARL
Status last verified
Jan 2026
First submitted
24 Jan 2024
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVt Vaccine in people with RSV Immunisation, run by Sanofi Pasteur, a Sanofi Company at 130 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United States, Japan, South Africa, Brazil, Finland and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06252285.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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