Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older

A Phase I/IIa, Randomized, Placebo-controlled Multi-arm Dose-finding Study to Evaluate the Safety and Immunogenicity of a RSV Vaccine Candidate in Adult Participants 18 to 50 Years of Age in Phase I, and 60 Years and Older in Phase IIa

Brief Summary of Stage 1:

The purpose of Stage 1 (Phase I/IIa) was to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate formulated with 2 different lipid nanoparticles (LNPs) in healthy adult participants aged between 18 to 50 years, and 60 years and older. The primary objectives of this stage were to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs. This stage evaluated the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.

Brief Summary of Stage 2:

The study also incorporated a Stage 2 (Phase IIa, dose-ranging design) that included adults aged 60 years and older to assess the safety and immunogenicity of different doses of RSV vaccine encapsulated in one of the LNPs. In the Phase IIa dose-ranging stage, eligible participants were randomly assigned in a 1:1:1 ratio to receive a single IM administration of RSV vaccine candidate doses, or placebo. Multiple safety analyses were performed, minimally at D07 and D28.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Immunization
• Intervention / Treatment: Other: Placebo; Biological: RSV vaccine candidate

Detailed Description

Stage 1:

The duration of each participant's participation was 12 months for the Sentinel and Main Cohorts, 24 months overall for the subset of participants enrolled in the Booster Cohort.

Treatment Duration:

• Sentinel Cohort: 1 intra-muscular (IM) injection. Participants were followed for 12 months post-vaccination.
• Main Cohort: 1 IM injection. Participants were followed for 12 months post-vaccination.
• Booster Cohort: 1 IM injection 12 months after the primary vaccination. Participants were followed for 12 months after administration of the booster dose.

Stage 2:

The duration of each participant's participation was approximately 6 months.

Treatment Duration:

1 IM injection. Participants were followed for approximately 6 months post vaccination

• Study Type: Interventional
• Enrollment (Actual): 865
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Southport, Australia, 4215
    • Investigational Site Number : 0360001
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Investigational Site Number : 0360003
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Investigational Site Number : 0360002
• Puerto Rico
  • Carolina, Puerto Rico, 984
    • Investigational Site Number : 6300004
  • Guayama, Puerto Rico, 000784
    • Investigational Site Number : 6300003
  • Guaynabo, Puerto Rico, 00968
    • Investigational Site Number : 6300005
  • San Juan, Puerto Rico, 00909
    • Investigational Site Number : 6300001
  • San Juan, Puerto Rico, 00918
    • Investigational Site Number : 6300002
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802
      • Optimal Research Alabama Site Number : 8400032
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Aventiv Research Mesa Site Number : 8400020
    • Peoria, Arizona, United States, 85381
      • CVS Health - Peoria Site Number : 8400042
    • Phoenix, Arizona, United States, 85019
      • CVS Health - Phoenix Site Number : 8400041
  • California
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research - San Diego - ERN - PPDS Site Number : 8400010
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates Site Number : 8400013
    • Thousand Oaks, California, United States, 91361
      • CVS Health - Thousand Oaks Site Number : 8400043
  • Florida
    • Hollywood, Florida, United States, 33024
      • Cenexel Research Centers of America Site Number : 8400024
    • Miami, Florida, United States, 33173
      • Suncoast Research Associates, LLC Site Number : 8400003
  • Georgia
    • Rincon, Georgia, United States, 31326
      • Centricity Research - Georgia Site Number : 8400009
  • Illinois
    • Peoria, Illinois, United States, 61614
      • AES Peoria Site Number : 8400030
    • River Forest, Illinois, United States, 60305
      • DM Clinical Research - Chicago Site Number : 8400027
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Be Well Clinical Studies Site Number : 8400036
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Velocity Clinical Research Site Number : 8400019
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research Site Number : 8400017
    • Columbus, Ohio, United States, 43213
      • Aventiv Research Columbus Site Number : 8400007
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Lynn Institute of Norman Site Number : 8400023
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research, Medford Site Number : 8400014
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research - Providence Site Number : 8400006
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center Site Number : 8400015
  • Texas
    • Houston, Texas, United States, 77065
      • DM Clinical Research - CyFair Site Number : 8400025
    • Round Rock, Texas, United States, 78681
      • Be Well Clinical Studies -Round Rock Site Number : 8400038
    • San Antonio, Texas, United States, 78229
      • IMA Clinical Research-San Antonio Site Number : 8400039
    • Tomball, Texas, United States, 77375
      • Martin Diagnostic Clinic Site Number : 8400026
  • Utah
    • West Jordan, Utah, United States, 84088-8865
      • Velocity Clinical Research Site Number : 8400018

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Sentinel Cohort Stage 1: Aged 18 to 50 years on the day of inclusion
• Main Cohort Stage 1 and Stage 2: Aged 60 years or older on the day of inclusion

Stage 1 and Stage 2:

• Sentinel Cohort: A female participant was eligible to participate if she was not pregnant or breastfeeding and:

  • Was of non-childbearing potential. To be considered of non-childbearing potential, a female must have been postmenopausal for at least 1 year or surgically sterile OR
  • Was of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.

• Main and Booster Cohorts: A female participant was eligible to participate if she was not pregnant or breastfeeding and:

  • Was of non-childbearing potential. To be considered of non-childbearing potential, a female must have been postmenopausal for at least 1 year or surgically sterile.
• Able to attend all scheduled visits and to comply with all study procedures
• Informed consent form was been signed and dated

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 systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA COVID-19 vaccine
• History of RSV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
• Previous history of myocarditis, pericarditis, and/or myopericarditis
• Thrombocytopenia or bleeding disorder, contraindicating IM injection based on investigator's judgment
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
• Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with study conduct or completion
• Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
• Participation at the time of study enrollment (or in the 4 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
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Self-reported or documented human immunodeficiency virus (HIV) detected by any FDA-approved/validated test, hepatitis B virus surface antigen (HBsAg), hepatits B core antibodies (HBcAb), or hepatitis C virus antibodies (HCV Abs), or positive SARS-CoV-2 RT-PCR or antigen test
• Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study

The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

17

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1: Sentinel Cohort: RSV Vaccine Dose A1; Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose A1 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Experimental: Stage 1: Sentinel Cohort: RSV Vaccine Dose A2; Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose A2 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Experimental: Stage 1: Sentinel Cohort: RSV Vaccine Dose B1; Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose B1 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Experimental: Stage 1: Sentinel Cohort: RSV Vaccine Dose B2; Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose B2 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Experimental: Stage 1: Sentinel Cohort: RSV Vaccine Dose C1; Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose C1 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Experimental: Stage 1: Sentinel Cohort: RSV Vaccine Dose C2; Participants enrolled in the Sentinel Cohort received 0.5 mL RSV vaccine dose C2 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Placebo Comparator: Stage 1: Sentinel Cohort: Placebo; Participants enrolled in the Sentinel Cohort received 0.5 mL placebo matched to RSV vaccine as an IM injection on Day 1 of Stage 1.	Other: Placebo; Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection
Experimental: Stage 1: Main Cohort: RSV Vaccine Dose A1; Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose A1 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Experimental: Stage 1: Main Cohort: RSV Vaccine Dose A2; Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose A2 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Experimental: Stage 1: Main Cohort: RSV Vaccine Dose B1; Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose B1 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Experimental: Stage 1: Main Cohort: RSV Vaccine Dose B2; Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose B2 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Experimental: Stage 1: Main Cohort: RSV Vaccine Dose C1; Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose C1 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Experimental: Stage 1: Main Cohort: RSV Vaccine Dose C2; Participants enrolled in the Main Cohort received 0.5 mL RSV vaccine dose C2 as an IM injection on Day 1 of Stage 1.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Placebo Comparator: Stage 1: Main Cohort: Placebo; Participants enrolled in the Main Cohort received 0.5 mL placebo matched to RSV vaccine as an IM injection on Day 1 of Stage 1.	Other: Placebo; Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection
Experimental: Stage 2: RSV Vaccine Dose C2; Participants received 0.5 mL RSV vaccine dose C2 as an IM injection on Day 1 of Stage 2.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Experimental: Stage 2: RSV Vaccine Dose D; Participants received 0.5 mL RSV vaccine dose D as an IM injection on Day 1 of Stage 2.	Biological: RSV vaccine candidate; Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Placebo Comparator: Stage 2: Placebo; Participants received 0.5 mL placebo matched to RSV vaccine as an IM injection on Day 1 of Stage 2.	Other: Placebo; Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination.	Up to 30 minutes post-primary vaccination on Day 1
Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions	An injection site reaction was an adverse reaction (AR) at and around the injection site of the study vaccine. Injection site reactions were commonly inflammatory reactions. Solicited injection site reactions were reactions at and around the injection site of the study vaccine observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions were systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited reactions were considered to be related to the study vaccine administered.	From Day 1 (first dose of primary vaccination) up to Day 8 (7 days post-primary vaccination on Day 1)
Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Unsolicited Adverse Events	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.	From Day 1 (first dose of primary vaccination) up to Day 29 (28 days post-primary vaccination on Day 1)
Stage 1 (Sentinel and Main Cohort): Number of Participants With Medically Attended Adverse Events (MAAEs)	An MAAE was a new-onset or a worsening of a condition that prompted the participant to seek unplanned medical advice at a physician's office or Emergency Department.	From Day 1 (first dose of primary vaccination) up to Day 29 (28 days post-primary vaccination on Day 1)
Stage 2: Number of Participants With Medically Attended Adverse Events	An MAAE was a new-onset or a worsening of a condition that prompted the participant to seek unplanned medical advice at a physician's office or Emergency Department.	From Day 1 (first dose of primary vaccination) to Day 180
Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor was appropriate.	From Day 1 (first dose of primary vaccination) to Day 365 (Stage 1 Sentinel and Main Cohorts); From Day 1 (first dose of primary vaccination) to Day 180 (Stage 2)
Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Shifts From Baseline to Out-of-Range Biological Test Results	Clinical evaluation of laboratory parameters (hematology, clinical chemistry and coagulation parameters) was performed to determine out-of-range values (below or above normal range). Number of participants with a shift from baseline to out-of-range value within 7 days after primary vaccination (Day 8) are reported. Laboratory parameters with a notable shift from baseline included: hematology: hemoglobin, white blood cells (WBC), red blood cells (RBC); clinical chemistry: blood urea nitrogen (BUN), potassium, glucose, C-reactive protein (CRP), direct bilirubin, troponin I; and coagulation parameters: partial thromboplastin time (PTT).	From baseline (Day -14 to Day -1) up to Day 8 (7 days post-primary vaccination on Day 1)
Stage 1 (Sentinel and Main Cohort): Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Respiratory Syncytial Virus A	Neutralizing antibodies activity against RSV A was measured using the RSV plaque reduction neutralization test (PRNT) (micro-PRNT). RSV A serum neutralizing antibodies titers were expressed as 1/dilution.	Day 1 (pre-primary vaccination) and Day 29 (28 days post-primary vaccination on Day 1)
Stage 2: Geometric Mean Titers of Neutralizing Antibodies Against Respiratory Syncytial Virus A and Respiratory Syncytial Virus B	Neutralizing antibodies activity against RSV A and RSV B was measured using the RSV PRNT (micro-PRNT). RSV A and RSV B serum neutralizing antibodies titers were expressed as 1/dilution.	Day 1 (pre-primary vaccination) and Day 29 (28 days post-primary vaccination on Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage 1 (Booster Cohort): Number of Participants With Immediate Unsolicited Systemic Adverse Events	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.	Up to 30 minutes post-booster vaccination at Month 12
Stage 1 (Booster Cohort): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions	An injection site reaction was an AR at and around the injection site of the study vaccine. Injection site reactions were commonly inflammatory reactions. Solicited injection site reactions were reactions at and around the injection site of the study vaccine observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions were systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited reactions were considered to be related to the study vaccine administered.	Up to 7 days post-booster vaccination at Month 12
Stage 1 (Booster Cohort): Number of Participants With Unsolicited Adverse Events and Medically Attended Adverse Events	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination. An MAAE was a new-onset or a worsening of a condition that prompted the participant to seek unplanned medical advice at a physician's office or Emergency Department.	Up to 28 days post-booster vaccination at Month 12
Stage 1 (Booster Cohort): Number of Participants With Serious Adverse Events and Adverse Events of Special Interest	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor was appropriate.	From Month 12 (first dose of booster vaccination) to Month 24
Stage 1 (Booster Cohort): Number of Participants With Shifts From Baseline to Out-of-Range Biological Test Results	Clinical evaluation of laboratory parameters (hematology and clinical chemistry) was performed to determine out-of-range values (below or above normal range). Number of participants with a shift from baseline to out-of-range value within 7 days after booster vaccination (Month 12 + 7 days) are reported. Laboratory parameters with a notable shift from baseline included: hematology: RBC; clinical chemistry: potassium, glucose, direct bilirubin.	From baseline (Month 12: Day -14 to Day -1) up to 7 days post-booster vaccination at Month 12
Stage 1 (Sentinel and Main Cohort): Geometric Mean Titers of Neutralizing Antibodies Against Respiratory Syncytial Virus A	Neutralizing antibodies activity against RSV A was measured using the RSV PRNT (micro-PRNT). RSV A serum neutralizing antibodies titers were expressed as 1/dilution.	3, 6, and 12 months post-primary vaccination on Day 1
Stage 1 (Sentinel and Main Cohort): Geometric Mean Concentration of Binding Antibodies Against Respiratory Syncytial Virus Anti-F Immunoglobulin G (IgG)	Binding antibodies activity against RSV anti-F IgG was measured using enzyme-linked immunosorbent assay (ELISA). Geometric mean concentrations were expressed as endotoxin units per milliliter (EU/mL).	Day 1 (pre-primary vaccination), Day 29, and 3, 6, and 12 months post-primary vaccination on Day 1
Stage 1 (Booster Cohort): Geometric Mean Titers of Neutralizing Antibodies Against Respiratory Syncytial Virus A	Neutralizing antibodies activity against RSV A was measured using the RSV PRNT (micro-PRNT). RSV A serum neutralizing antibodies titers were expressed as 1/dilution.	Month 12 (pre-booster vaccination), and 28 days (Month 13), 3 months (Month 15), 6 months (Month 18), and 12 months (Month 24) post-booster vaccination at Month 12
Stage 1 (Booster Cohort): Geometric Mean Concentration of Binding Antibodies Against Respiratory Syncytial Virus Anti-F Immunoglobulin G	Binding antibodies activity against RSV anti-F IgG was measured using ELISA. Geometric mean concentrations were expressed as EU/mL.	Month 12 (pre-booster vaccination), and 28 days (Month 13), 3 months (Month 15), 6 months (Month 18), and 12 months (Month 24) post-booster vaccination on Month 12
Stage 2: Geometric Mean Concentration of Binding Antibodies Against Respiratory Syncytial Virus Anti-F Immunoglobulin G	Binding antibodies activity against RSV anti-F IgG was measured using ECL assay. Geometric mean concentrations were expressed as arbitrary units (AU)/mL.	Day 1 (pre-primary vaccination) and Day 29 (28 days post-primary vaccination on Day 1)

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

Helpful Links

• VAE00010 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Actual): May 2, 2025
• Study Completion (Actual): May 2, 2025

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: VAE00010; U1111-1271-1514 (Registry Identifier: ICTRP); 2023-505343-40 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes