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

Phase 3TerminatedNCT06397768

Sanofi Pasteur, a Sanofi Company2,226 enrolled

Overview

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.

The study duration is approximately 9 months for each participant. * Cohort 1: Visits at 6, 7, and 8 and 9 months of age for both groups with visit at 10 months of age for Group 2 only * Cohort 2: Visits at 12, 13, 14 and 15 months of age for both groups with visit at 16 months of age for Group 4 only * Routine pediatric vaccines (authorized auxiliary medicinal products (AxMP) will be administered at 6 months in Cohort 1 and 12 months of age in Cohort 2, as per Advisory Committee on Immunization Practice (ACIP) or local country recommendations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

2,226

Conditions

RSV Immunization

Interventions

RSVt vaccineBIOLOGICAL

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

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

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

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

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

Hepatitis B vaccineBIOLOGICAL

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

Streptococcus pneumoniae vaccineBIOLOGICAL

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

Rotavirus vaccineBIOLOGICAL

Pharmaceutical form:Oral solution-Route of administration:Oral

Measles, mumps, and rubella vaccineBIOLOGICAL

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

Varicella virus vaccineBIOLOGICAL

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

PlaceboBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Antibody titers at Day 85

Time frame: Day 85

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

Antibody titers at Day 85

Time frame: Day 85

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

Antibody titers at Day 113

Time frame: Day 113

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

Antibody titers at Day 113

Time frame: Day 113

Secondary Outcomes

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

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

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

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

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

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

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

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

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

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

Anti-tetanus Ab concentrations ≥ 0.1 IU/mL Cohort 1

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

Anti-pneumococcal Ab concentrations measured by electrochemiluminescence (ECL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F Cohort 1

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

Anti-measles Ab concentrations ≥ 255 mIU/mL Cohort 2

Antibody titers 28 days after the 12 month routine vaccinations

Time frame: 28 days after the 12 month routine vaccinations

Anti-mumps Ab concentrations ≥ 10 antibody units (AbU/mL) Cohort 2

Antibody titers 28 days after the 12 month routine vaccinations

Time frame: 28 days after the 12 month routine vaccinations

Anti-rubella Ab concentrations ≥ 10 IU/mL Cohort 2

Antibody titers 28 days after the 12 month routine vaccinations

Time frame: 28 days after the 12 month routine vaccinations

Anti-varicella Ab concentrations ≥ 5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL Cohort 2

Antibody 28 days after the 12 month routine vaccinations

Time frame: 28 days after the 12 month routine vaccinations

Anti-pneumococcal Ab concentrations measured by ECL Cohort 2

Antibody titers 28 days after the 12 month routine vaccinations

Time frame: 28 days after the 12 month routine vaccinations

Descriptive: Anti-PRP Ab concentrations (µg/mL) Cohort 1

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

Descriptive: Anti-diphtheria Ab concentrations (IU/mL) Cohort 1

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

Descriptive: Anti-diphtheria Ab concentrations ≥ 0.01 IU/mL Cohort 1

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

Descriptive: Anti-tetanus Ab concentrations (IU/mL) Cohort 1

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

Descriptive: Anti-tetanus Ab concentrations ≥ 0.01 IU/mL Cohort 1

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

Descriptive: Anti-HBsAg Ab concentrations (mIU/mL) Cohort 1

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

Descriptive: Anti-HBsAg Ab concentrations ≥ 100 mIU/mL Cohort 1

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

Descriptive: Anti-poliovirus types (1, 2, and 3) Ab titers Cohort 1

Antibody titers 28 days after the 6 month routine vaccinations

Time frame: 28 days after the 6 month routine vaccinations

Descriptive: Anti-measles Ab concentrations (mIU/mL) Cohort 2

Antibody titers 28 days after the 12 month routine vaccinations

Time frame: 28 days after the 12 month routine vaccinations

Descriptive: Anti-mumps Ab concentrations (AbU/mL) Cohort 2

Antibody titers 28 days after the 12 month routine vaccinations

Time frame: 28 days after the 12 month routine vaccinations

Descriptive: Anti-rubella Ab concentrations (IU/mL) Cohort 2

Antibody titers 28 days after the 12 month routine vaccinations

Time frame: 28 days after the 12 month routine vaccinations

Descriptive: Anti-varicella Ab concentrations (gpELISA units/mL)

Antibody titers 28 days after the 12 month routine vaccinations

Time frame: 28 days after the 12 month routine vaccinations

RSV A serum neutralizing antibody titers by baseline serostatus at Day 1 Cohort 1 and Cohort 2

Antibody titers at Day 1

Time frame: Day 1

RSV B serum neutralizing antibody titers by baseline serostatus at Day 1 Cohort 1 and Cohort 2

Antibody titers at Day 1

Time frame: Day 1

RSV A serum neutralizing antibody titers by baseline serostatus 28 days post-dose 2 1 Cohort 1 and Cohort 2

Antibody titers 28 days post-dose 2

Time frame: 28 days post-dose 2

RSV B serum neutralizing antibody titers by baseline serostatus 28 days post-dose 2 Cohort 1 and Cohort 2

Antibody titers 28 days post-dose 2

Time frame: 28 days post-dose 2

Presence of solicited administration site reactions within 21 days after each investigational medicinal product (IMP) administration Cohort 1 and Cohort 2

Number of participants experiencing solicited administration site reactions

Time frame: 21 days after each IMP administration

Presence of solicited systemic reactions within 21 days after each IMP administration Cohort 1 and Cohort 2

Number of participants experiencing solicited systemic site reactions

Time frame: 21 days after each IMP administration

Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each study intervention administration Cohort 1 and Cohort 2

Number of participants experiencing unsolicited systemic adverse events

Time frame: Within 30 minutes after each study intervention administration

Presence of unsolicited AEs within 28 days after each study intervention administration Cohort 1 and Cohort 2

Number of participants experiencing unsolicited AEs

Time frame: Within 28 days after each study intervention administration

Presence of medically attended adverse events (MAAEs) throughout the study Cohort 1 and Cohort 2

Number of participants experiencing MAAEs

Time frame: Throughout the study, approximately 9 months

Presence of serious adverse events (SAEs) throughout the study Cohort 1 and Cohort 2

Number of participants experiencing SAEs

Time frame: Throughout the study, approximately 9 months

Presence of adverse events of special interest (AESIs) throughout the study Cohort 1 and Cohort 2

Number of participants experiencing AESIs

Time frame: Throughout the study, approximately 9 months

Data from ClinicalTrials.gov

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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

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