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Cancer Vaccine

RSV Vaccine for Respiratory Syncytial Virus

Phase 4
Waitlist Available
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of a current immunosuppressive condition or receipt of chemotherapy or other immunosuppressive or cytotoxic therapy, including chronic prednisone use of ≥ 20 mg/day for more than 14 days within 3 months of study vaccination
Previous receipt or intended receipt of an RSV vaccine outside the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial studies how well a new vaccine works in adults over 60 in nursing homes vs. adults in the community.

Who is the study for?
This trial is for adults over 60 living in long-term care facilities or independently, with a life expectancy of more than 6 months. They must be able to consent themselves or through a representative. It's not for those with immune system issues, recent high-dose steroids, severe vaccine allergies, other vaccines close to the study period, prior RSV vaccination outside the study, or recent blood products or RSV infection.
What is being tested?
The trial is examining how effective newly licensed RSV vaccines are in older adults residing in nursing homes compared to those living on their own. The focus is on comparing the immune responses between these two groups after receiving the vaccine.
What are the potential side effects?
While specific side effects aren't listed here, common reactions to vaccines may include soreness at injection site, fatigue, headache, muscle pain and sometimes fever. Severe allergic reactions are rare but possible.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken high-dose steroids or other immune-weakening drugs recently.
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I have received or plan to receive an RSV vaccine not part of this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
mean peak serum neutralizing antibody against RSV
Secondary study objectives
mean peak serum binding antibody to RSV prefusion F protein against RSV A & B

Side effects data

From 2021 Phase 2 trial • 1153 Patients • NCT04032093
69%
Injection site pain (PAIN AT INJECTION SITE)
47%
Fatigue (FATIGUE)
44%
Myalgia (MUSCLE PAIN)
37%
Headache (HEADACHE)
26%
Nausea (NAUSEA)
13%
Vomiting (VOMITING)
12%
Arthralgia (JOINT PAIN)
11%
Diarrhoea (DIARRHOEA)
5%
Injection site swelling (SWELLING)
5%
Pyrexia (FEVER)
4%
Injection site erythema (REDNESS)
4%
Streptococcus test positive
3%
Pre-eclampsia
3%
Bacterial disease carrier
3%
Anaemia
3%
Gastrooesophageal reflux disease
3%
Urinary tract infection
3%
Perineal injury
3%
Anxiety
2%
Nonreassuring foetal heart rate pattern
2%
Arrested labour
2%
Premature delivery
2%
Thrombocytopenia
2%
Mastitis
2%
Depression
2%
Fall
2%
Dizziness
2%
Gestational hypertension
2%
Headache
2%
Dyspepsia
2%
Perinatal depression
1%
Ectopic pregnancy
1%
Joint dislocation
1%
Osteitis
1%
Foetal distress syndrome
1%
Foetal hypokinesia
1%
Migraine
1%
Prolonged rupture of membranes
1%
Bacterial test positive
1%
Shoulder dystocia
1%
Rash
1%
Cephalo-pelvic disproportion
1%
Retained placenta or membranes
1%
Oropharyngeal pain
1%
Anaemia of pregnancy
1%
Influenza virus test positive
1%
Premature labour
1%
Nausea
1%
Gastroenteritis
1%
Upper respiratory tract infection
1%
SARS-CoV-2 test positive
1%
Syncope
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide
Infant Participants: RSVpreF 120 mcg
Maternal Participants: RSVpreF 120 mcg
Maternal Participants: RSVpreF 240 mcg
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide
Maternal Participants: Placebo
Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide
Infant Participants: RSVpreF 240 mcg
Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide
Infant Participants: Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Long-term care facility residentsExperimental Treatment1 Intervention
Licensed RSV vaccine IM x 1. Specific product to be determined availability at the facility as SOC
Group II: community dwelling adultsActive Control1 Intervention
Licensed RSV vaccine IM x1. The proportion of specific products will be matched to the LTCF cohort
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSV vaccine
2019
Completed Phase 2
~1160

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
869 Previous Clinical Trials
549,610 Total Patients Enrolled
~76 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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