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RSVpreF Vaccine for Bronchitis (RENOIR Trial)

Phase 3

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration

Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated

Must not have

Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in ssa

Awards & highlights

Pivotal Trial

Summary

This trial will test if RSVpreF is safe and effective in preventing LRTI-RSV in adults.

Who is the study for?

Adults aged 60 and older who can consent to the study, are generally healthy or have stable chronic disease, live independently or with minimal assistance, and agree to use contraception if applicable. Excluded are those on immunosuppressive therapy, with bleeding disorders, severe vaccine allergies, recent blood product receipt, prior RSV vaccination or participation in other drug trials.

What is being tested?

The trial is testing a single dose of RSVpreF against placebo for preventing lung infections caused by RSV in older adults. It includes two substudies: one assessing safety after a second dose at 2 years and another at 1 year post-initial dose. Participants will be monitored for up to 24 months.

What are the potential side effects?

While specific side effects aren't listed here, common vaccine-related side effects may include pain at injection site, fatigue, headache, muscle pain, chills fever and nausea. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man who can father children and agree to use effective birth control during and after the study.

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I am willing and able to follow the study's schedule, use a mobile app for symptom tracking, and collect nasal swabs as required.

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I am 60 years old or older.

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I am not able to become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never received an RSV vaccine and don't plan to during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in ssb

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in ssb

This trial's timeline: 3 weeks for screening, Varies for treatment, and before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in ssb for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy Study: Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season

Efficacy Study: Proportion of participants reporting AE within 1-month after vaccination

Efficacy Study: Proportion of participants reporting NDCMC throughout the study

+25 more

Secondary study objectives

Efficacy Study: Number of first episode of ARI-RSV across 2 RSV seasons

Efficacy Study: Number of first episode of ARI-RSV in the second RSV season

Efficacy Study: Number of first episode of LRTI-RSV across 2 RSV seasons

+13 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

9Treatment groups

Experimental Treatment

Placebo Group

Group I: SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 4 revaccination)Experimental Treatment1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at the Year 3 vaccination followed by RSVpreF at the Year 4 vaccination in SSC.

Group II: SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 3 revaccination)Experimental Treatment1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive RSVpreF at the Year 3 vaccination followed by placebo at the Year 4 vaccination in SSC.

Group III: SSB: Vaccination of RSVpreF recipients with RSVpreF (Year 1 revaccination)Experimental Treatment1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive RSVpreF in SSB.

Group IV: SSA: Vaccination of RSVpreF recipients with RSVpreF (Year 2 revaccination)Experimental Treatment1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive RSVpreF in SSA.

Group V: Efficacy Study: RSVpreF vaccineExperimental Treatment1 Intervention

RSVpreF

Group VI: SSC: Vaccination of RSVpreF recipients with PlaceboPlacebo Group1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at both the Year 3 and Year 4 vaccination in SSC.

Group VII: SSB: Vaccination of RSVpreF recipients with PlaceboPlacebo Group1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive Placebo in SSB.

Group VIII: Efficacy Study: Placebo dosePlacebo Group1 Intervention

Placebo

Group IX: SSA: Vaccination of RSVpreF recipients with PlaceboPlacebo Group1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive Placebo in SSA.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RSVpreF

2023