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Virus Therapy
Combined Vaccine for COVID-19 Prevention
Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after vaccination
Summary
This trial tests a new combined vaccine for RSV and COVID-19 in adults aged 65 or older. The goal is to see if it is safe and effective. The combined vaccine aims to make it easier to stay protected against multiple respiratory infections.
Who is the study for?
This trial is for people aged 65 or older who are healthy or have stable chronic conditions. They must have had at least three US-authorized mRNA COVID-19 vaccines, with the last being a bivalent booster given over 150 days ago. Participants should not have received a flu shot in the past 120 days and must be able to attend all study visits and procedures.
What is being tested?
The trial is testing a combined vaccine against RSV and COVID-19, which may also be administered with a seasonal flu vaccine. The goal is to see if this combination can safely reduce the number of shots needed to prevent respiratory infections.
What are the potential side effects?
While specific side effects aren't listed, typical reactions could include soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea. Severe allergic reactions are rare but possible.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1 month after vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 month after vaccination
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4
GMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 4
+13 moreSecondary study objectives
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 6 Versus Group 4
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 6 Versus Group 4
+9 moreTrial Design
7Treatment groups
Experimental Treatment
Active Control
Group I: Group 7Experimental Treatment3 Interventions
Coadministration RSVpreF + bivalent BNT162b2 + QIV
Group II: Group 6Experimental Treatment3 Interventions
Coadministration RSVpreF + bivalent BNT162b2 + placebo
Group III: Group 2Experimental Treatment2 Interventions
Combination \[RSVpreF+BNT162b2\] + placebo
Group IV: Group 1Experimental Treatment2 Interventions
Combination \[RSVpreF+BNT162b2\] + Quadrivalent influenza vaccine (QIV)
Group V: Group 4Active Control2 Interventions
RSVpreF + placebo
Group VI: Group 5Active Control2 Interventions
QIV + placebo
Group VII: Group 3Active Control2 Interventions
BNT162b2 + placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bivalent BNT162b2 (original/Omi BA.4/BA.5)
2023
Completed Phase 2
~1150
Normal Saline Placebo
2023
Completed Phase 4
~1790
RSVpreF
2023
Completed Phase 3
~17240
Combination [RSVpreF+BNTb162b2]
2023
Completed Phase 2
~1150
QIV
2022
Completed Phase 3
~5600
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Vaccines are the most common treatments for healthy subjects to prevent infectious diseases. They work by stimulating the immune system to recognize and fight specific pathogens without causing the disease itself.
For example, mRNA vaccines for COVID-19 instruct cells to produce a protein that triggers an immune response, while traditional vaccines may use inactivated viruses or viral proteins. This immune response prepares the body to fight the actual virus if exposed in the future.
The combined RSV and COVID-19 vaccine aims to reduce the number of shots needed by providing protection against both viruses simultaneously, which is particularly beneficial for healthy subjects by simplifying vaccination schedules and enhancing compliance.
A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.The race to treat COVID-19: Potential therapeutic agents for the prevention and treatment of SARS-CoV-2.
A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.The race to treat COVID-19: Potential therapeutic agents for the prevention and treatment of SARS-CoV-2.
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,675 Previous Clinical Trials
28,716,039 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,756,895 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Participants must be 65 years old or older at the first visit.You have a condition that makes it unsafe for you to receive an injection in your muscle because it could cause prolonged bleeding.You are allergic to eggs or chicken.You have a weakened immune system due to a medical condition or medication.You have received a respiratory syncytial virus (RSV) vaccine before or plan to get one during the study.You are 65 years old or older at the first visit.You have received at least 3 mRNA COVID-19 vaccines, with the most recent being an updated vaccine given at least 150 days before the start of the study.You have been diagnosed with COVID-19, RSV infection, or the flu in the last 120 days.You had a bad reaction to a vaccine or are very allergic to any part of the study treatment.You got a flu shot within the last 120 days before the study starts.You have received at least three mRNA COVID-19 vaccines, with the most recent one being an updated version given at least 150 days before the start of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 7
- Group 2: Group 4
- Group 3: Group 5
- Group 4: Group 1
- Group 5: Group 2
- Group 6: Group 3
- Group 7: Group 6
Awards:
This trial has 0 awards, including: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.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05886777 — Phase 2