Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers

NCT06397768 | Terminated Phase 3 DMC FDA Drug

• 3 other identifiers: VAD00016U1111-1290-73562024-000262-15
• Study Type: interventional
• Target: 2,226
• Locations: 3 countries
• Sites: 72

Brief Summary

This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine \[Vaxelis® or Pentacel® and Recombivax HB®\] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.

Conditions

RSV Immunization

Outcome Measures

Primary Outcomes (4)

• RSV A serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3

  Antibody titers at Day 85

  Day 85

• RSV B serum neutralizing antibody titers at 28 days post dose 2 (D85) Groups 1 and 3

  Antibody titers at Day 85

  Day 85

• RSV A serum neutralizing antibody titers at Day 113 Groups 2 and 4

  Antibody titers at Day 113

  Day 113

• RSV B serum neutralizing antibody titers at Day 113 Groups 2 and 4

  Antibody titers at Day 113

  Day 113

Secondary Outcomes (35)

• Anti- hepatitis B surface antigen (HBsAg) Immunoglobulin g (IgG) antibody (A)b concentrations ≥ 10 milli international units per milliliter (mIU/mL) Cohort 1

  28 days after the 6 month routine vaccinations

• Anti- polyribosylribitol phosphate (PRP) Ab concentrations ≥ 0.15 micrograms per milliliter (µg/mL) Cohort 1

  28 days after the 6 month routine vaccinations

• Anti-poliovirus types (1, 2, and 3) Ab titers ≥ 1:8 Cohort 1

  28 days after the 6 month routine vaccinations

• Anti-pertussis Ab concentrations pertussis toxin, filamentous hemagglutinin , pertactin, fimbriae (PT, FHA, PRN, FIM) Cohort 1

  28 days after the 6 month routine vaccinations

• Anti-diphtheria Ab concentrations ≥ 0.1 IU/mL Cohort 1

  28 days after the 6 month routine vaccinations

Study Arms (4)

Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months)

EXPERIMENTAL

Participants will be administered RSVt vaccine concomitantly with routine pediatric vaccines, 2 doses, at age 6 months. Vaccines administered at age 6 months: RSVt Vaxelis or Pentacel and Recombivax HB, Prevnar 20, and RotaTeq. Placebo will be administered non-concomitantly at 7 months of age

Biological: RSVt vaccine; Biological: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine; Biological: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine; Biological: Hepatitis B vaccine; Biological: Streptococcus pneumoniae vaccine; Biological: Rotavirus vaccine; Biological: Placebo

Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months)

EXPERIMENTAL

Participants will be administered RSVt vaccine non-concomitantly with routine pediatric vaccines, 2 doses, at age 7 months. Vaccines administered at age 6 months: Vaxelis or Pentacel and Recombivax HB, Prevnar 20, and RotaTeq. Placebo will be administered concomitantly at 6 months of age

Biological: RSVt vaccine; Biological: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine; Biological: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine; Biological: Hepatitis B vaccine; Biological: Streptococcus pneumoniae vaccine; Biological: Rotavirus vaccine; Biological: Placebo

Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months)

EXPERIMENTAL

Participants will be administered RSVt vaccine concomitantly with routine pediatric vaccines, 2 doses, at age 12 months. Vaccines administered at age 6 months: M-M-R II, VARIVAX, and Prevnar 20. Placebo will be administered non-concomitantly at 13 months of age

Biological: RSVt vaccine; Biological: Streptococcus pneumoniae vaccine; Biological: Measles, mumps, and rubella vaccine; Biological: Varicella virus vaccine; Biological: Placebo

Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months)

EXPERIMENTAL

Participants will be administered RSVt vaccine non-concomitantly with routine pediatric vaccines, 2 doses, at age 13 months. Vaccines administered at age 6 months: M-M-R II, VARIVAX, and Prevnar 20. Placebo will be administered concomitantly at 12 months of age

Biological: RSVt vaccine; Biological: Streptococcus pneumoniae vaccine; Biological: Measles, mumps, and rubella vaccine; Biological: Varicella virus vaccine; Biological: Placebo

Interventions

Rotavirus vaccine BIOLOGICAL

Pharmaceutical form:Oral solution-Route of administration:Oral

Also known as: RotaTeq®

Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months); Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months)

Measles, mumps, and rubella vaccine BIOLOGICAL

Pharmaceutical form:Lyophilized live virus for reconstitution -Route of administration:Subcutaneous or Intramuscular

Also known as: M-M-R® II

Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months); Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months)

Varicella virus vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Subcutaneous or Intramuscular

Also known as: VARIVAX®

Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months); Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months)

Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Also known as: Pentacel®

Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months); Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months)

Hepatitis B vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Also known as: RECOMBIVAX HB® or alternate monovalent hepatitis B vaccine

Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months); Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months)

Streptococcus pneumoniae vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Also known as: PREVNAR 20®

Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months); Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months); Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months); Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months)

Placebo BIOLOGICAL

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal

Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months); Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months); Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months); Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months)

RSVt vaccine BIOLOGICAL

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal

Also known as: 534

Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months); Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months); Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months); Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months)

Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Also known as: Vaxelis®

Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months); Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months)

Eligibility Criteria

• Age: 6 Months - 12 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 and physical examination
• For Cohort 1: Infant received doses of vaccines containing hepatitis B, diphtheria, tetanus, pertussis, Haemophilus influenzae type B (Hib), and inactivated poliovirus vaccine (IPV) antigens, with Advisory Committee on Immunization Practice (ACIP) recommended vaccines. The last dose(s) of these vaccines must be at least 28 days before the first study visit
• Infant received the recommended doses of a recommended pneumococcal conjugate vaccine (as per local schedule) at least 28 days before the first study visit.

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 previous infection with diphtheria, tetanus, Hib, measles, mumps, rubella, rotavirus, pneumococcus, polio, hepatitis B virus
• 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 living with human immunodeficiency virus (HIV)
• 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
• History of definitive contraindications to any of the concomitant vaccines that will be administered as part of the study protocol
• Participant's biological mother with previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (72)

Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400007

Birmingham, Alabama, 35205, United States

Location

South Alabama Medical Clinic- Site Number : 8400065

Grand Bay, Alabama, 36541, United States

Location

MedPharmics - Mobile - Dauphin Street- Site Number : 8400017

Mobile, Alabama, 36608, United States

Location

Northwest Arkansas Pediatric Clinic- Site Number : 8400002

Fayetteville, Arkansas, 72703, United States

Location

Alliance Research Institute - Bell Gardens - Garfield Avenue- Site Number : 8400040

Bell Gardens, California, 90201, United States

Location

Matrix Clinical Research - Huntington Park- Site Number : 8400018

Huntington Park, California, 90255, United States

Location

Paradigm Clinical Research Centers- Site Number : 8400059

La Mesa, California, 91942, United States

Location

Matrix Clinical Research - Los Angeles- Site Number : 8400008

Los Angeles, California, 90057, United States

Location

Kaiser Permanente - Oakland Medical Center- Site Number : 8400047

Oakland, California, 94611, United States

Location

Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400070

Palo Alto, California, 94304, United States

Location

Kaiser Permanente - Sierra Gardens- Site Number : 8400063

Roseville, California, 95661, United States

Location

Kaiser Permanente - Point West Medical Offices- Site Number : 8400064

Sacramento, California, 95815, United States

Location

Kaiser Permanente - San Jose Medical Center- Site Number : 8400060

San Jose, California, 95119, United States

Location

Kaiser Permanente - Santa Clara Medical Center- Site Number : 8400061

Santa Clara, California, 95051, United States

Location

Integrated Clinical Research LLC- Site Number : 8400036

Sherman Oaks, California, 91356-4173, United States

Location

Kaiser Permanente - Walnut Creek Medical Center- Site Number : 8400062

Walnut Creek, California, 94596, United States

Location

Velocity Clinical Research - Washington DC- Site Number : 8400050

Washington D.C., District of Columbia, 20016, United States

Location

Prohealth Research Center- Site Number : 8400068

Doral, Florida, 33166, United States

Location

The Medici Medical Research- Site Number : 8400055

Hollywood, Florida, 33021, United States

Location

Dade Research Center- Site Number : 8400014

Miami, Florida, 33126, United States

Location

Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400015

Miami Lakes, Florida, 33014, United States

Location

SEC Clinical Research - Pensacola- Site Number : 8400034

Pensacola, Florida, 32501, United States

Location

PAS Research- Site Number : 8400005

Tampa, Florida, 33613, United States

Location

Leavitt Women's Healthcare- Site Number : 8400009

Idaho Falls, Idaho, 83404, United States

Location

Velocity Clinical Research - Sioux City- Site Number : 8400054

Sioux City, Iowa, 51106, United States

Location

Alliance for Multispeciality Research - El Dorado- Site Number : 8400019

El Dorado, Kansas, 67042, United States

Location

University of Kentucky Chandler Medical Center- Site Number : 8400051

Lexington, Kentucky, 40536, United States

Location

Velocity Clinical Research - New Orleans- Site Number : 8400058

New Orleans, Louisiana, 70119, United States

Location

Research Works INC- Site Number : 8400044

New Orleans, Louisiana, 70125, United States

Location

Velocity Clinical Research - Gulfport- Site Number : 8400011

Gulfport, Mississippi, 39503, United States

Location

QPS Bio-Kinetic Clinical Applications- Site Number : 8400046

Springfield, Missouri, 65802, United States

Location

Boeson Research - Great Falls- Site Number : 8400041

Great Falls, Montana, 59405, United States

Location

Boeson Research - Missoula- Site Number : 8400006

Missoula, Montana, 59804, United States

Location

Velocity Clinical Research - Grand Island- Site Number : 8400016

Grand Island, Nebraska, 68803, United States

Location

Midwest Childrens Health Research Institute- Site Number : 8400038

Lincoln, Nebraska, 68516, United States

Location

Velocity Clinical Research - Omaha- Site Number : 8400001

Omaha, Nebraska, 68134, United States

Location

PAS Research - Henderson- Site Number : 8400049

Henderson, Nevada, 89014, United States

Location

NYU Langone Cardiothoracic Surgery Associates - Garden City- Site Number : 8400048

Garden City, New York, 11530, United States

Location

Summerwood Pediatrics- Site Number : 8400021

Liverpool, New York, 13088, United States

Location

SUNY Upstate Medical University - Syracuse- Site Number : 8400029

Syracuse, New York, 13210, United States

Location

Dayton Clinical Research- Site Number : 8400030

Dayton, Ohio, 45409, United States

Location

Ohio Pediatrics - Dayton- Site Number : 8400033

Dayton, Ohio, 45414, United States

Location

Senders Pediatrics- Site Number : 8400022

South Euclid, Ohio, 44121, United States

Location

Cyn3rgy Research- Site Number : 8400053

Gresham, Oregon, 97030, United States

Location

Square-1 Clinical Research- Site Number : 8400031

Erie, Pennsylvania, 16506, United States

Location

Pas Research - Pittsburgh- Site Number : 8400043

Pittsburgh, Pennsylvania, 15227, United States

Location

Neighbors Pediatrics- Site Number : 8400072

Charleston, South Carolina, 29407, United States

Location

Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400012

Greenville, South Carolina, 29607, United States

Location

South Texas Clinical Research- Site Number : 8400004

Corpus Christi, Texas, 78413, United States

Location

Javara - Privia Medical Group North Texas - Dallas- Site Number : 8400003

Dallas, Texas, 75230, United States

Location

PAS Research - Children's Care Clinic- Site Number : 8400035

Edinburg, Texas, 78539, United States

Location

Helios Clinical Research - Fort Worth - 8th Avenue- Site Number : 8400020

Fort Worth, Texas, 76104, United States

Location

Ventavia Research Group - Houston - North Loop West- Site Number : 8400010

Houston, Texas, 77008, United States

Location

The University of Texas Health Science Center- Site Number : 8400037

Houston, Texas, 77030, United States

Location

DM Clinical Research - Houston - Jones Road- Site Number : 8400052

Houston, Texas, 77065, United States

Location

Mercury Clinical Research - Houston - Savoy Drive- Site Number : 8400045

Houston, Texas, 77070, United States

Location

La Providence Pediatrics & Family Clinics- Site Number : 8400039

Houston, Texas, 77071, United States

Location

Houston Clinical Research Associates- Site Number : 8400013

Houston, Texas, 77090, United States

Location

University of Texas Medical Branch at Galveston- Site Number : 8400057

League City, Texas, 77555, United States

Location

Maximos Ob/Gyn- Site Number : 8400024

League City, Texas, 77573, United States

Location

Research Your Health- Site Number : 8400066

Plano, Texas, 75093, United States

Location

Pediatric Center - Richmond- Site Number : 8400032

Richmond, Texas, 77469, United States

Location

North Houston Internal Medicine & Pediatric Clinic- Site Number : 8400025

Tomball, Texas, 77375, United States

Location

Utah Valley Pediatrics - Orem- Site Number : 8400067

Orem, Utah, 84057, United States

Location

Ogden Clinic - Mountain View - CCT Research- Site Number : 8400056

Pleasant View, Utah, 84404, United States

Location

Wee Care Pediatrics - Roy- Site Number : 8400071

Roy, Utah, 84067, United States

Location

Investigational Site Number : 4840001

Mexico City, Mexico City, 04530, Mexico

Location

Investigational Site Number : 4840002

Temixco, Morelos, 62587, Mexico

Location

Investigational Site Number : 4840004

Mexico City, 06760, Mexico

Location

Investigational Site Number : 6300001

Caguas, 00725, Puerto Rico

Location

Investigational Site Number : 6300003

Ponce, 00716, Puerto Rico

Location

Investigational Site Number : 6300004

Trujillo Alto, 00976, Puerto Rico

Location

Related Links

• VAD00016 Plain Language Results Summary

MeSH Terms

Interventions

YM 534; Tetanus Toxoid; Hepatitis B Vaccines; Vaxelis; Poliovirus Vaccines; pentacel; Recombivax HB; Pneumococcal Vaccines; Rotavirus Vaccines; RotaTeq; Measles-Mumps-Rubella Vaccine; Herpes Zoster Vaccine; Chickenpox Vaccine

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Viral Hepatitis Vaccines; Viral Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines, Combined; Measles Vaccine; Mumps Vaccine; Rubella Vaccine; Herpesvirus Vaccines

Study Design

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

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 3, 2024
• Study Start: May 13, 2024
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

ME (3); PR (3); US (66)