Save

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

PHASE2RECRUITING

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.

Simpliy with AI

Study details:

Study duration per participant:. 6 months. Treatment Duration:.

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

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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

Simplify with AI

Eligibility

Age eligible for study : 60 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-04-02

Primary completion: 2025-02-18

Study completion finish: 2025-02-18

Study type

PREVENTION

Phase

PHASE2

Trial ID

NCT06251024

Intervention or treatment

BIOLOGICAL: RSV vaccine candidate

BIOLOGICAL: Placebo

Conditions

• Healthy Volunteers
• Respiratory Syncytial Virus Infection

Condition: Healthy Volunteers, Respiratory Syncytial Virus Infection
BIOLOGICAL: RSV vaccine candidate and other drugs
Botany, New South Wales, Australia and more
Sponsor: Sanofi Pasteur, a Sanofi Company

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Investigational Site Number : 0360003

Research sites nearby

Select from list below to view details:

Investigational Site Number : 0360003
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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 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 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)

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older