Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older

A Phase IIb, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an RSV Vaccine Candidate in Adult Participants 60 Years and Older

The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV.

The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a pre-determined dose of the RSV vaccine candidate or placebo.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Respiratory Syncytial Virus Infection
• Intervention / Treatment: Biological: Placebo; Biological: RSV vaccine candidate

Detailed Description

Study duration per participant:

6 months.

Treatment Duration:

1 IM injection. Participants will be followed for approximately 6 months post- vaccination.

• Study Type: Interventional
• Enrollment (Actual): 4541
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Norwood, Australia, 5067
    • Investigational Site Number : 0360005
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Investigational Site Number : 0360003
  • Queensland
    • Sippy Downs, Queensland, Australia, 4556
      • Investigational Site Number : 0360004
    • Southport, Queensland, Australia, 4222
      • Investigational Site Number : 0360001
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Investigational Site Number : 0360002
• Chile
  • Santiago, Chile, 7500657
    • Investigational Site Number : 1520002
  • Santiago, Chile, 7510157
    • Investigational Site Number : 1520008
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
      • Investigational Site Number : 1520005
    • Santiago, Reg Metropolitana de Santiago, Chile, 8380453
      • Investigational Site Number : 1520001
    • Santiago, Reg Metropolitana de Santiago, Chile, 8420383
      • Investigational Site Number : 1520004
  • Región del Biobío
    • Concepción, Región del Biobío, Chile, 4070094
      • Investigational Site Number : 1520006
• Colombia
  • Aguazul, Colombia, 856010
    • Investigational Site Number : 1700004
  • Barranquilla, Colombia, 080020
    • Investigational Site Number : 1700002
  • Bogotá, Colombia, 110111
    • Investigational Site Number : 1700006
  • Cali, Colombia, 76001
    • Investigational Site Number : 1700007
  • Girardot, Colombia, 252431
    • Investigational Site Number : 1700003
  • Ibagué, Colombia, 730001
    • Investigational Site Number : 1700005
  • Quindío, Colombia, 630001
    • Investigational Site Number : 1700001
• Dominican Republic
  • Santo Domingo, Dominican Republic, 10205
    • Investigational Site Number : 2140001
  • Santo Domingo, Dominican Republic, 10205
    • Investigational Site Number : 2140002
• Honduras
  • San Pedro Sula, Honduras, 21104
    • Investigational Site Number : 3400001
  • Tegucigalpa, Honduras, 11101
    • Investigational Site Number : 3400003
  • Tegucugalpa, Honduras, 11101
    • Investigational Site Number : 3400002
• Mexico
  • Querétaro, Mexico, 76100
    • Investigational Site Number : 4840003
  • Guanajuato
    • León, Guanajuato, Mexico, 37000
      • Investigational Site Number : 4840002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 60 years or older on the day of inclusion

• A female participant is eligible to participate if she is not pregnant or breastfeeding and:

  • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile.

• Participants with high-risk medical conditions who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion.

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

• 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 an mRNA 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, contraindicating IM injection based on investigator's judgment
• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection
• Chronic illness that, in the opinion of the investigator, is 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 any vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine in the 4 weeks following any study intervention administration
• Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
• Previous vaccination against RSV with a licensed or investigational vaccine or planned receipt during study participation, of vaccination against RSV with a licensed or investigational vaccine other than the study vaccine
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months
• 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 Note: The above information is not intended to contain all considerations relevant to a patient's 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: RSV vaccine candidate; Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the RSV vaccine candidate.	Biological: RSV vaccine candidate; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Placebo Comparator: Group 2: placebo; Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the placebo.	Biological: Placebo; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination	Number of participants experiencing RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination	≥ 14 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of solicited injection site or systemic reactions	Number of participants reporting: injection site reactions: pain, erythema and swelling; systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills	Within 7 days after primary vaccination
Presence of the first episode of RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination	Number of participants experiencing RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination	≥ 14 days after vaccination
Presence of the first episode of RSV MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination	Number of participants experiencing RSV-MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination	≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A) occurring ≥ 14 days after vaccination)	Number of participants experiencing RSV-LRTD (RSV A) ≥ 14 days after vaccination	≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV B) occurring ≥ 14 days after vaccination	Number of participants experiencing RSV-LRTD (RSV B) ≥ 14 days after vaccination	≥ 14 days after vaccination
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B and by each one) by age group	Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by age group	≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline comorbidities	Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline comorbidities	≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline frailty status	Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline frailty status	≥ 14 days after vaccination
Presence of hospitalization due to RSV-ARD and/or RSV-LRTD	Number of participants hospitalized due to RSV-ARD and/or RSV-LRTD	≥ 14 days after vaccination
Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)	Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)	≥ 14 days after vaccination
Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)	Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)	≥ 14 days after vaccination
Presence of the first episode of severe RSV LRTD (RSV A and/or RSV B and by each one) occurring ≥ 14 days after vaccination	Number of participants experiencing severe RSV-LRTD (RSV A and/or B and by each one)	≥ 14 days after vaccination
RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	Day 1 and Day 29
RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	Day 1 and Day 29
Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset	Day 1 and Day 29
RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset	RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset	Month 6
RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset	RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset	Month 6
Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset	Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset	Month 6
Presence of unsolicited immediate systemic adverse events (AEs)	Number of participants experiencing an unsolicited immediate systemic adverse event	Within 30 minutes after primary vaccination
Presence of unsolicited AEs	Number of participants experiencing unsolicited AEs	Within 28 days after primary vaccination
Presence of serious adverse events (SAEs)	Number of participants experiencing SAEs	Throughout study (approximately 6 months)
Presence of medically attended adverse events (MAAEs)	Number of participants experiencing MAAEs	Throughout study (approximately 6 months)
Presence of adverse events of special interest (AESIs)	Number of participants experiencing AESIs	Throughout study (approximately 6 months)

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• VAE00017 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Actual): March 11, 2025
• Study Completion (Actual): March 11, 2025

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: VAE00017 (Other Identifier: Sanofi Identifier); U1111-1271-1514 (Other Identifier: ICTRP)

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