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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
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 belowSelect...
I am a man who can father children and agree to use effective birth control during and after the study.
Select...
I am willing and able to follow the study's schedule, use a mobile app for symptom tracking, and collect nasal swabs as required.
Select...
I am 60 years old or older.
Select...
I am not able to become pregnant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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
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 moreSecondary 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 moreTrial 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
Completed Phase 3
~17130
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,625 Previous Clinical Trials
14,245,627 Total Patients Enrolled
5 Trials studying Bronchitis
53,218 Patients Enrolled for Bronchitis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,420,203 Total Patients Enrolled
4 Trials studying Bronchitis
1,263 Patients Enrolled for Bronchitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not able to become pregnant.I am a man who can father children and agree to use effective birth control during and after the study.I have not received blood products or immunoglobulin in the last 60 days.I have never received an RSV vaccine and don't plan to during the study.I can take care of myself and do daily activities on my own.I haven't taken strong immune system medications or had radiation for 60 days.I am willing and able to follow the study's schedule, use a mobile app for symptom tracking, and collect nasal swabs as needed.I am healthy with a stable condition that hasn't needed more treatment or hospitalization in the last 6 weeks.I am willing and able to follow the study's schedule, use a mobile app for symptom tracking, and collect nasal swabs as required.I can take care of myself and live at home or in a place that offers little help.I can sign and follow the study's consent form and rules.I am 60 years old or older.I am not able to become pregnant.I am a man who can father children and agree to use effective birth control during and for 28 days after the study.I do not have a bleeding disorder that makes injections unsafe for me.I do not have any serious chronic conditions that would prevent me from joining the study.I can sign and follow the study's consent form and rules.I am 60 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: SSA: Vaccination of RSVpreF recipients with RSVpreF (Year 2 revaccination)
- Group 2: SSB: Vaccination of RSVpreF recipients with RSVpreF (Year 1 revaccination)
- Group 3: SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 3 revaccination)
- Group 4: SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 4 revaccination)
- Group 5: SSC: Vaccination of RSVpreF recipients with Placebo
- Group 6: SSB: Vaccination of RSVpreF recipients with Placebo
- Group 7: Efficacy Study: RSVpreF vaccine
- Group 8: Efficacy Study: Placebo dose
- Group 9: SSA: Vaccination of RSVpreF recipients with Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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