Pfizer is committed to advancing vaccine protection against respiratory syncytial virus (RSV). Learn more about a clinical trial for previous Renoir (C3671013) study participants.
Thanks to your participation in the Renoir clinical trial, Pfizer’s RSV vaccine (ABRYSVO®) has already helped protect millions of people around the world. However, our work is not done. Because vaccine protection may decrease over time, it is important to determine if revaccination may be needed.
This clinical trial will help us learn if receiving an additional dose of the RSV vaccine 5 years after the first dose is safe and if any potential side effects are manageable.
Who may participate
This study may be an option if you:
- Are 65 years of age or older
- Received Pfizer's RSV vaccine about 5 years ago as part of the Renoir (C3671013) clinical trial and have not received a licensed or investigational RSV vaccine since
- Are generally healthy or have stable chronic medical conditions
- Do not have a history of severe reactions associated with any vaccine
The study team can discuss additional requirements with you and help find out if you qualify.
Age
65+ years
Medical history
Generally healthy or have stable chronic medical conditions
Vaccination history
Received Pfizer's RSV vaccine about 5 years ago as part of the Renoir clinical trial and have not received a licensed or investigational RSV vaccine since
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this study is a good fit for you and you agree to take part, you will be assigned by chance (like pulling a number out of a hat) to receive a standard dose of the RSV vaccine, a higher dose of the RSV vaccine, or no vaccine.
You will be in the study for about a year and a half and will have 5 visits with the study team.
There is no cost to participate, and health insurance is not required. Compensation for time and travel is available and will be explained by the study team.
Your safety is the most important part of this clinical trial, and your health will be carefully monitored by the study team. You can contact the study team at any time if you have questions or concerns about your health.
Number of vaccine doses
0 or 1
Study visit schedule
5 visits over about 18 months
Study-related costs
No cost to participate, and you will be paid for completing study related activities.
About the study vaccine
The vaccine being studied (ABRYSVO®) is an RSV vaccine developed by Pfizer. Based on the results of the Renoir clinical trial, it has been approved for use in adults 60 years of age and older in many countries, including the United States, Argentina, and Japan.
As with any vaccine, local reactions at the injection site can occur – such as tenderness, redness, or swelling. There is also potential for other symptoms like fatigue (tiredness), headache, muscle pain, joint pain, or more serious side effects including an allergic reaction.
Your participation matters
Taking part in this clinical trial will help advance research into vaccine protection against RSV. On behalf of the study team, thank you for your ongoing dedication. Together, we’re shaping the future of vaccine research.
About respiratory syncytial virus
Respiratory syncytial virus (RSV) is a common virus that infects the nose, throat, and lungs. It usually spreads in the fall and winter and causes flu-like symptoms such as stuffy or runny nose, cough, and fever.
While anyone can get RSV, older adults have a higher risk of severe illness and complications like pneumonia (an infection of the lungs). Fortunately, there are RSV vaccines available that can help prevent serious illness for those at greatest risk.
Frequently asked questions
You may receive an additional dose of Pfizer’s RSV vaccine which could help protect you from serious illness, and your health will be closely monitored by the study team. You will also be contributing to research that may improve RSV vaccine protection for others around the world.
As with any vaccine, local reactions at the injection site can be common – such as tenderness, redness, or swelling. There is also potential for other symptoms like fatigue (tiredness), headache, muscle pain, joint pain, or more serious side effects including an allergic reaction. Study-related blood draws may cause discomfort, bruising, bleeding, and in rare cases, infection. There may be other risks that are unknown at this time. The study team will provide more information about the potential benefits and risks of taking part.
While all clinical trials come with some risks, participant safety is always the top priority. Clinical trials are reviewed by committees responsible for protecting the rights and safety of all participants. These committees continue to regularly review the trial’s progress to ensure there are no unnecessary or excessive risks to participants.
At the beginning of the clinical trial, the study doctor will ask about your medical history, including your medical conditions, previous vaccinations, and any medications you are currently taking. You may receive 1 dose of the study vaccine as an injection (shot) in your arm. You will also have your blood drawn 5 times throughout clinical trial. The study team will give you more information about all tests and procedures during your first study visit.
If you receive the study vaccine, you will use an electronic diary (eDiary) to report any changes in your health every day for at least 7 days after your vaccination, or up to 30 days if symptoms persist. You will also receive a thermometer to measure your temperature and a device to measure any redness or swelling that happens at the injection site. The study team will provide more information about the eDiary during your first study visit.
Participation is your choice. You can leave the clinical trial at any time, for any reason. Your decision to stop the study will not affect your regular medical care.
