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

NCT06251024 | Completed Phase 2 FDA Drug

• 2 other identifiers: VAE00017U1111-1271-1514
• Study Type: interventional
• Target: 4,541
• Locations: 6 countries
• Sites: 25

Brief Summary

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.

Conditions

Respiratory Syncytial Virus Infection; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Presence of the first episode of 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

  ≥ 14 days after vaccination

• Presence of the first episode of RSV LRTD (RSV A) occurring ≥ 14 days after vaccination)

  ≥ 14 days after vaccination

• Presence of the first episode of RSV LRTD (RSV B) occurring ≥ 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

  ≥ 14 days after vaccination

Study Arms (2)

Group 1: RSV vaccine candidate

EXPERIMENTAL

Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the RSV vaccine candidate.

Biological: RSV vaccine candidate

Group 2: placebo

PLACEBO COMPARATOR

Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the placebo.

Biological: Placebo

Interventions

RSV vaccine candidate BIOLOGICAL

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

Group 1: RSV vaccine candidate

Placebo BIOLOGICAL

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

Group 2: placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (25)

Investigational Site Number : 0360003

Botany, New South Wales, 2019, Australia

Location

Investigational Site Number : 0360004

Sippy Downs, Queensland, 4556, Australia

Location

Investigational Site Number : 0360001

Southport, Queensland, 4222, Australia

Location

Investigational Site Number : 0360002

Camberwell, Victoria, 3124, Australia

Location

Investigational Site Number : 0360005

Norwood, 5067, Australia

Location

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, 7580206, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 8380453, Chile

Location

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 8420383, Chile

Location

Investigational Site Number : 1520006

Concepción, Región del Biobío, 4070094, Chile

Location

Investigational Site Number : 1520002

Santiago, 7500657, Chile

Location

Investigational Site Number : 1520008

Santiago, 7510157, Chile

Location

Investigational Site Number : 1700004

Aguazul, 856010, Colombia

Location

Investigational Site Number : 1700002

Barranquilla, 080020, Colombia

Location

Investigational Site Number : 1700006

Bogotá, 110111, Colombia

Location

Investigational Site Number : 1700007

Cali, 76001, Colombia

Location

Investigational Site Number : 1700003

Girardot, 252431, Colombia

Location

Investigational Site Number : 1700005

Ibagué, 730001, Colombia

Location

Investigational Site Number : 1700001

Quindío, 630001, Colombia

Location

Investigational Site Number : 2140001

Santo Domingo, 10205, Dominican Republic

Location

Investigational Site Number : 2140002

Santo Domingo, 10205, Dominican Republic

Location

Investigational Site Number : 3400001

San Pedro Sula, 21104, Honduras

Location

Investigational Site Number : 3400003

Tegucigalpa, 11101, Honduras

Location

Investigational Site Number : 3400002

Tegucugalpa, 11101, Honduras

Location

Investigational Site Number : 4840002

León, Guanajuato, 37000, Mexico

Location

Investigational Site Number : 4840003

Querétaro, 76100, Mexico

Location

Related Links

• VAE00017 Plain Language Results Summary

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Investigators, laboratory personnel, sponsor and participants will be blinded * Study staff preparing/administering the study interventions will be unblinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel, multi-center, case driven

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: April 2, 2024
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CO (7); AU (5); DO (2); HO (3); ME (2); CL (6)