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

NCT06252285 | Terminated Phase 3 DMC FDA Drug

• 3 other identifiers: VAD000042023-505762-29U1111-1280-7192
• Study Type: interventional
• Target: 6,300
• Locations: 16 countries
• Sites: 130

Brief 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. 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.

Conditions

RSV Immunisation

Outcome Measures

Primary Outcomes (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

  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)

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

  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

  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

  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

  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

  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)

Study Arms (2)

Group 1 RSVt Vaccine

EXPERIMENTAL

Participants will receive 2 intranasal administrations of RSVt vaccine

Biological: RSVt Vaccine

Group 2 Control

PLACEBO COMPARATOR

Participants will receive 2 intranasal administrations of placebo

Biological: Placebo

Interventions

RSVt Vaccine BIOLOGICAL

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

Also known as: 534

Group 1 RSVt Vaccine

Placebo BIOLOGICAL

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

Group 2 Control

Eligibility Criteria

• Age: 6 Months - 21 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (130)

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

Birmingham, Alabama, 35205-1628, United States

Location

Lakeview Clinical Research- Site Number : 8400024

Guntersville, Alabama, 35976, United States

Location

Novak Clinical Research- Site Number : 8400069

Tucson, Arizona, 85741-2306, United States

Location

Madera Family Medical Group- Site Number : 8400029

Madera, California, 93637, United States

Location

Integrated Clinical Research- Site Number : 8400056

Tarzana, California, 91356, United States

Location

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

Victorville, California, 92395, United States

Location

Moore Clinical Research - Brandon- Site Number : 8400065

Brandon, Florida, 33511, United States

Location

Invictus Clinical Research Group- Site Number : 8400035

Coconut Creek, Florida, 33073, United States

Location

Site Number : 8400031

Doral, Florida, 33122-1088, United States

Location

Nona Pediatric Center- Site Number : 8400068

Orlando, Florida, 32829, United States

Location

Teena Hughes Pediatrics- Site Number : 8400042

Tampa, Florida, 33613, United States

Location

Morehouse School of Medicine - Atlanta- Site Number : 8400037

Atlanta, Georgia, 30310, United States

Location

Emory-Children's Center- Site Number : 8400001

Atlanta, Georgia, 30322-1014, United States

Location

Agile Clinical Research Trials- Site Number : 8400015

Atlanta, Georgia, 30328, United States

Location

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

Chamblee, Georgia, 30341, United States

Location

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

Macon, Georgia, 31210, United States

Location

iResearch Savannah - CenExel - PPDS- Site Number : 8400032

Savannah, Georgia, 31405-5701, United States

Location

Medical Research Partners - Ammon- Site Number : 8400059

Ammon, Idaho, 83406, United States

Location

Clinical Research Prime- Site Number : 8400013

Idaho Falls, Idaho, 83404, United States

Location

Leavitt Women's Healthcare- Site Number : 8400033

Idaho Falls, Idaho, 83404, United States

Location

Snake River Research- Site Number : 8400046

Idaho Falls, Idaho, 83404, United States

Location

Michigan Institute of Research- Site Number : 8400055

Allen Park, Michigan, 48101, United States

Location

Vida Clinical Studies - Dearborn Heights- Site Number : 8400072

Dearborn Heights, Michigan, 48127, United States

Location

Great Lakes Research Institute- Site Number : 8400060

Southfield, Michigan, 48075, United States

Location

Clinical Research Institute - Minneapolis- Site Number : 8400011

Minneapolis, Minnesota, 55402, United States

Location

Boeson Research - Great Falls- Site Number : 8400008

Great Falls, Montana, 59405, United States

Location

Velocity Clinical Research - Grand Island- Site Number : 8400017

Grand Island, Nebraska, 68803, United States

Location

Be Well Clinical Studies - Lincoln- Site Number : 8400058

Lincoln, Nebraska, 68516, United States

Location

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

Norfolk, Nebraska, 68701-2669, United States

Location

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

Omaha, Nebraska, 68114, United States

Location

Velocity Clinical Research - Omaha- Site Number : 8400054

Omaha, Nebraska, 68134, United States

Location

Prime Global Research, Inc.- Site Number : 8400043

The Bronx, New York, 10456-2102, United States

Location

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

Cincinnati, Ohio, 45229, United States

Location

Senders Pediatrics- Site Number : 8400006

South Euclid, Ohio, 44121, United States

Location

Cyn3rgy Research- Site Number : 8400014

Gresham, Oregon, 97030, United States

Location

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

Charleston, South Carolina, 29425, United States

Location

Palmetto Pediatrics- Site Number : 8400012

North Charleston, South Carolina, 29406, United States

Location

Parkside Pediatrics - Simpsonville- Site Number : 8400071

Simpsonville, South Carolina, 29681, United States

Location

Clinical Research Associates Inc- Site Number : 8400005

Nashville, Tennessee, 37203-2066, United States

Location

Tekton Research, LLC - Beaumont - PPDS- Site Number : 8400061

Beaumont, Texas, 77706-3061, United States

Location

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

Del Rio, Texas, 78840-3927, United States

Location

Ventavia Research Group - Fort Worth- Site Number : 8400022

Fort Worth, Texas, 76104, United States

Location

Private Practice - Dr. Chinyere N. Awa- Site Number : 8400066

Houston, Texas, 77057, United States

Location

DM Clinical Research - CyFair Clinical Research Center- Site Number : 8400044

Houston, Texas, 77065, United States

Location

Maximos Ob/Gyn- Site Number : 8400023

League City, Texas, 77573, United States

Location

Pediatric Center - Richmond- Site Number : 8400019

Richmond, Texas, 77469, United States

Location

Tekton Research - FM78- Site Number : 8400067

San Antonio, Texas, 78244, United States

Location

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

Layton, Utah, 84041, United States

Location

Wee Care Pediatrics - Roy- Site Number : 8400002

Roy, Utah, 84067, United States

Location

Wee Care Pediatrics - Syracuse- Site Number : 8400004

Syracuse, Utah, 84075, United States

Location

Investigational Site Number : 0320007

Buenos Aires, Buenos Aires F.D., C1425, Argentina

Location

Investigational Site Number : 0320003

Río Cuarto, Córdoba Province, X5800, Argentina

Location

Investigational Site Number : 0320005

Rosario, Santa Fe Province, S2013DTC, Argentina

Location

Investigational Site Number : 0320004

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Investigational Site Number : 0320002

SAN Miguel de Tucumã¡n, Tucumán Province, T4000, Argentina

Location

Investigational Site Number : 0320001

Buenos Aires, 1426, Argentina

Location

Investigational Site Number : 0320006

Buenos Aires, 1426, Argentina

Location

Obras Sociais Irmã Dulce - Patamares- Site Number : 0760009

Salvador, Estado de Bahia, 41680-020, Brazil

Location

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

Belo Horizonte, Minas Gerais, 30150-320, Brazil

Location

Hospital de Clinicas de Porto Alegre- Site Number : 0760005

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Ernesto Dornelles- Site Number : 0760007

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

Location

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

Ribeirão Preto, São Paulo, 14015-010, Brazil

Location

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

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

Location

Escola Paulista De Medicina- Site Number : 0760002

Vila Clementino, São Paulo, 04023-062, Brazil

Location

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

São Paulo, 04265-000, Brazil

Location

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 8331143, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 8380418, Chile

Location

Investigational Site Number : 1520005

Port Montt, 5480000, Chile

Location

Investigational Site Number : 1560009

Jiangsu, 221699, China

Location

Investigational Site Number : 1700004

Acacías, 507001, Colombia

Location

Investigational Site Number : 1700002

Chía, 250001, Colombia

Location

Investigational Site Number : 1700003

Girardot, 252431, Colombia

Location

Investigational Site Number : 2460003

Espoo, 02230, Finland

Location

Investigational Site Number : 2460005

Helsinki, 00100, Finland

Location

Investigational Site Number : 2460008

Jarvenpaa, 04400, Finland

Location

Investigational Site Number : 2460004

Kokkola, 67100, Finland

Location

Investigational Site Number : 2460002

Oulu, 90220, Finland

Location

Investigational Site Number : 2460006

Seinäjoki, 60100, Finland

Location

Investigational Site Number : 2460009

Tampere, 33100, Finland

Location

Investigational Site Number : 2460001

Turku, 20520, Finland

Location

Investigational Site Number : 3920008

Lizuka-shi, Fukuoka, 820-0040, Japan

Location

Investigational Site Number : 3920011

Sapporo, Hokkaido, 063-0841, Japan

Location

Investigational Site Number : 3920007

Kawagoe, Saitama, 350-0001, Japan

Location

Investigational Site Number : 3920010

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

Location

Investigational Site Number : 3920006

Edogawa-Ku, Tokyo, 133-0056, Japan

Location

Investigational Site Number : 3920001

Fukui, 910-0833, Japan

Location

Investigational Site Number : 3920002

Fukui-shi, 910-0808, Japan

Location

Investigational Site Number : 3920004

Fukuoka, 813-0036, Japan

Location

Investigational Site Number : 3920003

Kagoshima, 890-0034, Japan

Location

Investigational Site Number : 3920005

Kasuga-Shi, 816-0801, Japan

Location

Investigational Site Number : 3920009

Osaka, 556-0005, Japan

Location

Investigational Site Number : 4040007

Butere, 50101, Kenya

Location

Investigational Site Number : 4040002

Kisumu, 40100, Kenya

Location

Investigational Site Number : 4040003

Kisumu, 40100, Kenya

Location

Investigational Site Number : 4040001

Nairobi, 00202, Kenya

Location

Investigational Site Number : 4040006

Nairobi, KENYA, Kenya

Location

Investigational Site Number : 4840008

Monterrey, Nuevo León, 64060, Mexico

Location

Investigational Site Number : 4840007

Mexico City, 14090, Mexico

Location

Investigational Site Number : 4840004

Veracruz, 91900, Mexico

Location

Investigational Site Number : 5240003

Dhulikhel N.p, Bagmati, 45210, Nepal

Location

Investigational Site Number : 5240001

Kathmandu, Bagmati, 44600, Nepal

Location

Investigational Site Number : 5240002

Nepalgunj, Bheri, 21900, Nepal

Location

Clinical Research Investigator Group- Site Number : 6300001

Bayamón, 00961-7041, Puerto Rico

Location

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

Guayama, 00784, Puerto Rico

Location

Caribbean Medical Research Center- Site Number : 6300003

San Juan, 00918, Puerto Rico

Location

Hospital Pediatrico Universitario- Site Number : 6300002

San Juan, 00923, Puerto Rico

Location

Investigational Site Number : 7100007

Brits, 0250, South Africa

Location

Investigational Site Number : 7100008

City of Cape Town, 7500, South Africa

Location

Investigational Site Number : 7100001

East London, 5241, South Africa

Location

Investigational Site Number : 7100005

Johannesburg, 2001, South Africa

Location

Investigational Site Number : 7100004

Johannesburg, 2013, South Africa

Location

Investigational Site Number : 7100003

Johannesburg, 2193, South Africa

Location

Investigational Site Number : 7100006

Paarl, 7626, South Africa

Location

Investigational Site Number : 7100002

Pretoria, 0122, South Africa

Location

Investigational Site Number : 7100009

Soshanguve, 0152, South Africa

Location

Investigational Site Number : 7240004

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

Location

Investigational Site Number : 7240001

Barcelona, Catalunya [Cataluña], 08023, Spain

Location

Investigational Site Number : 7240003

Móstoles, Madrid, 28938, Spain

Location

Investigational Site Number : 7240005

Pamplona, Navarre, 31008, Spain

Location

Investigational Site Number : 7240002

Seville, Sevilla, 41013, Spain

Location

Investigational Site Number : 7640002

Bangkok, 10400, Thailand

Location

Investigational Site Number : 7640005

Bangkok, 10400, Thailand

Location

Investigational Site Number : 7640004

Bangkok, 10700, Thailand

Location

Investigational Site Number : 7640001

Chiang Mai, 50180, Thailand

Location

Investigational Site Number : 7640006

Hat Yai, 90110, Thailand

Location

Investigational Site Number : 7640003

Khon Kaen, 40002, Thailand

Location

Investigational Site Number : 8260003

Hayle, Cornwall, TR27 5DT, United Kingdom

Location

Investigational Site Number : 8260005

Exeter, Devon, EX2 5DW, United Kingdom

Location

Investigational Site Number : 8260007

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Investigational Site Number : 8260004

Bristol, BS1 3NU, United Kingdom

Location

Related Links

• VAD00004 Plain Language Results Summary

MeSH Terms

Interventions

YM 534

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Blinding for vaccine group assignment: participants, parents or legally acceptable representatives (LARs), outcome assessors, investigators, laboratory personnel, Sponsor study staff * No blinding for study staff who prepare and administer the study interventions
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 9, 2024
• Study Start: February 6, 2024
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

NE (3); US (50); KE (5); JP (11); CN (1); AR (7); FI (8); CO (3); ME (3); ZA (9); ES (5); CL (3); GB (4); TH (6); PR (4); BR (8)