Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

TERMINATED

NCT06397768

PHASE3

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

Sponsor: Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

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.

Official title: Phase III, Randomized, Single-blind, Placebo-controlled, Multi-center Study to Evaluate Non-interference of Concomitant Administration of Routine Pediatric Vaccines on the Antibody Response of an Investigational Live-attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Infants and Toddlers (CORAL)

Key Details

Gender

All

Age Range

6 Months - 12 Months

Study Type

INTERVENTIONAL

Enrollment

2226

Start Date

2024-05-13

Completion Date

2025-09-18

Last Updated

2026-10-05

Healthy Volunteers

Yes

Conditions

RSV Immunization

Interventions

BIOLOGICAL

RSVt vaccine

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

Hepatitis B vaccine

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

BIOLOGICAL

Streptococcus pneumoniae vaccine

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

BIOLOGICAL

Rotavirus vaccine

Pharmaceutical form:Oral solution-Route of administration:Oral

BIOLOGICAL

Measles, mumps, and rubella vaccine

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

BIOLOGICAL

Varicella virus vaccine

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

BIOLOGICAL

Placebo

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

Inclusion Criteria: * Aged 6 months for Cohort 1 and 12 months for Cohort 2 on the day of inclusion ("6 months" means from the day of the 6-month birthday to the day before the 7-month birthday and "12 months" means from the day of the 12-month birthday to the day before the 13-month birthday) * 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. Exclusion Criteria: * 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 * Receipt of any vaccine in the 4 weeks preceding RSVt vaccine administration or planned receipt of any vaccine outside of study protocol in the 4 weeks following RSVt vaccine administration, except for influenza and/or COVID-19 vaccination, which may be received at least 1 week before or 1 week after RSVt vaccine administration * 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 * 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 * Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration or planned receipt for duration of the study * For Cohort 1: Prior receipt of routine 6-month pediatric vaccine doses (as per local schedule) * For Cohort 2: Prior receipt of routine 12-month pediatric vaccine doses (as per local schedule) * Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Locations (72)

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

Birmingham, Alabama, United States

South Alabama Medical Clinic- Site Number : 8400065

Grand Bay, Alabama, United States

MedPharmics - Mobile - Dauphin Street- Site Number : 8400017

Mobile, Alabama, United States

Northwest Arkansas Pediatric Clinic- Site Number : 8400002

Fayetteville, Arkansas, United States

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

Bell Gardens, California, United States

Matrix Clinical Research - Huntington Park- Site Number : 8400018

Huntington Park, California, United States

Paradigm Clinical Research Centers- Site Number : 8400059

La Mesa, California, United States

Matrix Clinical Research - Los Angeles- Site Number : 8400008

Los Angeles, California, United States

Kaiser Permanente - Oakland Medical Center- Site Number : 8400047

Oakland, California, United States

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

Palo Alto, California, United States

Kaiser Permanente - Sierra Gardens- Site Number : 8400063

Roseville, California, United States

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

Sacramento, California, United States

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

San Jose, California, United States

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

Santa Clara, California, United States

Integrated Clinical Research LLC- Site Number : 8400036

Sherman Oaks, California, United States

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

Walnut Creek, California, United States

Velocity Clinical Research - Washington DC- Site Number : 8400050

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

Prohealth Research Center- Site Number : 8400068

Doral, Florida, United States

The Medici Medical Research- Site Number : 8400055

Hollywood, Florida, United States

Dade Research Center- Site Number : 8400014

Miami, Florida, United States

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

Miami Lakes, Florida, United States

SEC Clinical Research - Pensacola- Site Number : 8400034

Pensacola, Florida, United States

PAS Research- Site Number : 8400005

Tampa, Florida, United States

Leavitt Women's Healthcare- Site Number : 8400009

Idaho Falls, Idaho, United States

Velocity Clinical Research - Sioux City- Site Number : 8400054

Sioux City, Iowa, United States

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

El Dorado, Kansas, United States

University of Kentucky Chandler Medical Center- Site Number : 8400051

Lexington, Kentucky, United States

Velocity Clinical Research - New Orleans- Site Number : 8400058

New Orleans, Louisiana, United States

Research Works INC- Site Number : 8400044

New Orleans, Louisiana, United States

Velocity Clinical Research - Gulfport- Site Number : 8400011

Gulfport, Mississippi, United States

QPS Bio-Kinetic Clinical Applications- Site Number : 8400046

Springfield, Missouri, United States

Boeson Research - Great Falls- Site Number : 8400041

Great Falls, Montana, United States

Boeson Research - Missoula- Site Number : 8400006

Missoula, Montana, United States

Velocity Clinical Research - Grand Island- Site Number : 8400016

Grand Island, Nebraska, United States

Midwest Childrens Health Research Institute- Site Number : 8400038

Lincoln, Nebraska, United States

Velocity Clinical Research - Omaha- Site Number : 8400001

Omaha, Nebraska, United States

PAS Research - Henderson- Site Number : 8400049

Henderson, Nevada, United States

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

Garden City, New York, United States

Summerwood Pediatrics- Site Number : 8400021

Liverpool, New York, United States

SUNY Upstate Medical University - Syracuse- Site Number : 8400029

Syracuse, New York, United States

Dayton Clinical Research- Site Number : 8400030

Dayton, Ohio, United States

Ohio Pediatrics - Dayton- Site Number : 8400033

Dayton, Ohio, United States

Senders Pediatrics- Site Number : 8400022

South Euclid, Ohio, United States

Cyn3rgy Research- Site Number : 8400053

Gresham, Oregon, United States

Square-1 Clinical Research- Site Number : 8400031

Erie, Pennsylvania, United States

Pas Research - Pittsburgh- Site Number : 8400043

Pittsburgh, Pennsylvania, United States

Neighbors Pediatrics- Site Number : 8400072

Charleston, South Carolina, United States

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

Greenville, South Carolina, United States

South Texas Clinical Research- Site Number : 8400004

Corpus Christi, Texas, United States

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

Dallas, Texas, United States

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

Edinburg, Texas, United States

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

Fort Worth, Texas, United States

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

Houston, Texas, United States

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

Houston, Texas, United States

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

Houston, Texas, United States

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

Houston, Texas, United States

La Providence Pediatrics & Family Clinics- Site Number : 8400039

Houston, Texas, United States

Houston Clinical Research Associates- Site Number : 8400013

Houston, Texas, United States

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

League City, Texas, United States

Maximos Ob/Gyn- Site Number : 8400024

League City, Texas, United States

Research Your Health- Site Number : 8400066

Plano, Texas, United States

Pediatric Center - Richmond- Site Number : 8400032

Richmond, Texas, United States

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

Tomball, Texas, United States

Utah Valley Pediatrics - Orem- Site Number : 8400067

Orem, Utah, United States

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

Pleasant View, Utah, United States

Wee Care Pediatrics - Roy- Site Number : 8400071

Roy, Utah, United States

Investigational Site Number : 4840001

Mexico City, Mexico City, Mexico

Investigational Site Number : 4840002

Temixco, Morelos, Mexico

Investigational Site Number : 4840004

Mexico City, Mexico

Investigational Site Number : 6300001

Caguas, Puerto Rico

Investigational Site Number : 6300003

Ponce, Puerto Rico

Investigational Site Number : 6300004

Trujillo Alto, Puerto Rico

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (72)