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

Sanofi Pasteur, a Sanofi Company4,541 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

4,541

Conditions

Respiratory Syncytial Virus Infection Healthy Volunteers

Interventions

RSV vaccine candidateBIOLOGICAL

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

PlaceboBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (25)

Investigational Site Number : 0360003

Outcomes

Primary Outcomes

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

Time frame: ≥ 14 days after vaccination

Secondary Outcomes

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

Time frame: ≥ 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

Time frame: ≥ 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

Time frame: ≥ 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

Time frame: ≥ 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

Time frame: ≥ 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

Data from ClinicalTrials.gov

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Botany, New South Wales, Australia

Investigational Site Number : 0360004

Sippy Downs, Queensland, Australia

Investigational Site Number : 0360001

Southport, Queensland, Australia

Investigational Site Number : 0360002

Camberwell, Victoria, Australia

Investigational Site Number : 0360005

Norwood, Australia

Investigational Site Number : 1520006

Concepción, Biobio, Chile

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520002

Santiago, Chile

...and 15 more locations

Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline comorbidities

Time frame: ≥ 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

Time frame: ≥ 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

Time frame: ≥ 14 days after vaccination

Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)

Time frame: ≥ 14 days after vaccination

Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)

Time frame: ≥ 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)

Time frame: ≥ 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

Time frame: Day 1 and Day 29

RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset

Time frame: 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

Time frame: Day 1 and Day 29

RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset

Time frame: Month 6

RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset

Time frame: Month 6

Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset

Time frame: Month 6

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

Time frame: Within 7 days after primary vaccination

Presence of unsolicited immediate systemic adverse events (AEs)

Number of participants experiencing an unsolicited immediate systemic adverse event

Time frame: Within 30 minutes after primary vaccination

Presence of unsolicited AEs

Number of participants experiencing unsolicited AEs

Time frame: Within 28 days after primary vaccination

Presence of serious adverse events (SAEs)

Number of participants experiencing SAEs

Time frame: Throughout study (approximately 6 months)

Presence of medically attended adverse events (MAAEs)

Number of participants experiencing MAAEs

Time frame: Throughout study (approximately 6 months)

Presence of adverse events of special interest (AESIs)

Number of participants experiencing AESIs

Time frame: Throughout study (approximately 6 months)