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

Sanofi Pasteur, a Sanofi Company25 sites in 6 countries4,541 target enrollmentApril 2, 2024

ConditionsRespiratory Syncytial Virus Infection Healthy Volunteers

InterventionsRSV vaccine candidate Placebo

DrugsRSV vaccine candidate Placebo

Overview

Phase: Phase 2
Intervention: RSV vaccine candidate
Conditions: Respiratory Syncytial Virus Infection
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 4541
Locations: 25
Primary Endpoint: Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed Description

Study duration per participant: 6 months. Treatment Duration: 1 IM injection. Participants will be followed for approximately 6 months post- vaccination.

Registry

clinicaltrials.gov

Start Date

April 2, 2024

End Date

March 11, 2025

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: RSV vaccine candidate

Group 2: placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination

Time Frame: ≥ 14 days after vaccination

Number of participants experiencing RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination

Secondary Outcomes

Presence of hospitalization due to RSV-ARD and/or RSV-LRTD(≥ 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 and/or RSV B and by each one) by baseline frailty status(≥ 14 days after vaccination)
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 LRTD (RSV B) occurring ≥ 14 days after vaccination(≥ 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(Day 1 and Day 29)
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)
Presence of the first episode of severe RSV LRTD (RSV A and/or RSV B and by each one) occurring ≥ 14 days after vaccination(≥ 14 days after vaccination)
RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset(Month 6)
Presence of solicited injection site or systemic reactions(Within 7 days after primary 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 A and/or RSV B and by each one) by baseline comorbidities(≥ 14 days after vaccination)
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)(Within 30 minutes after primary vaccination)
Presence of unsolicited AEs(Within 28 days after primary vaccination)
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)(≥ 14 days after vaccination)
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(Day 1 and Day 29)
Presence of serious adverse events (SAEs)(Throughout study (approximately 6 months))
RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset(Month 6)
Presence of medically attended adverse events (MAAEs)(Throughout study (approximately 6 months))
Presence of adverse events of special interest (AESIs)(Throughout study (approximately 6 months))