There are no approved medicines for treating people with RSV infection. Learn more about the SHINE-HR clinical trial.

The SHINE-HR (high risk) clinical trial can help us learn about the potential benefits of a study medicine in people with RSV who have underlying health conditions. By participating in the SHINE-HR clinical trial, you can help us learn if this study medicine is effective in people with RSV who also have other health risks, and if it can prevent severe illness caused by this virus. Participants will receive care from a team of dedicated healthcare professionals throughout the duration of the clinical trial.

Who may participate

If your age is between 18 and 64, you can participate if you have one or more of the following which increase the risk of RSV severity:

  • a long-term lung disease
  • heart failure
  • a condition that weakens the immune system

If you are 65 (+), you can participate even if you do not have any of these conditions listed above.

Participation will last for about 5 weeks.

The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people. Many factors, such as genetics, race, ethnicity, gender, and age, can impact how people respond to a medicine. That is why it is so important that clinical trials include people of all backgrounds. Everyone needs to be represented.

Condition

Respiratory Syncytial Virus (RSV) infection, with high-risk severity

Age

18+ years

Sex

Male or Female

Each clinical trial 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 clinical trial.

Get started – See if you may be eligible

Answer a 2-minute questionnaire.

A first step as you consider this study is to answer a 2-minute online questionnaire about your health and medical history. If your answers show the study might be a good fit for you, you may choose to have your contact information shared with a Pfizer Clinical Trial Contact Center Navigator.

Speak with a study representative.

If you’re interested, a Pfizer Clinical Trial Contact Center Navigator will call you and do a more detailed review of the study and your medical history to see if you may be able to participate and be referred to a study clinic that you select.

Confirm your eligibility.

Your answers to these questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.

 

What to expect

In this trial, you will have certain tests, procedures, and activities. What happens at each visit will vary and some visits may take longer than others.

The clinical trial visits may include the following activities:

  • Blood draw
  • Physical examination
  • Questionnaires
  • Electrocardiogram (ECG)

Through a process called randomization, you will be assigned to a treatment group by chance (like flipping a coin) rather than by choice.

This trial is double-blind, which means that neither you nor the trial team will know whether you are receiving the study medicine or the placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.

You will be reimbursed for any reasonable expenses that you may have as a result of taking part in this trial. This may include parking, meals, or other travel-related expenses.

Length of clinical trial treatment

About 5 weeks

Number of clinical trial visits

7-8 visits, lasting about 1-3 hours including some phone visits

Long-term follow up

30 days

About Respiratory Syncytial Virus (RSV)

RSV (respiratory syncytial virus) is a potentially dangerous, highly contagious virus that can make it difficult to breathe and possibly require a stay in hospital.

RSV can be spread by touching a contaminated surface, or if an infected person coughs or sneezes and their droplets contact another person’s eyes, nose or mouth. Symptoms can appear like the common cold.

If you are 65 and older, or live with heart disease, long-term lung disease, or a condition that weakens your immune system, you could be at an increased risk of severe RSV.

About Respiratory Syncytial Virus (RSV)

Fall family with bus, Pfizer RSV – Pfizer Clinical Trials
Fall family with bus, Pfizer RSV – Pfizer Clinical Trials

Frequently asked questions

What is drug development?

Drug development is the journey from an idea for a potential medicine all the way through to bringing that new medicine to patients who need it. The development process includes laboratory research and a series of clinical trials.

Along the way, important information is collected about the potential medicine and how it affects clinical trial participants. If that information shows the potential medicine is safe and effective, clinical trial sponsors provide the information to regulatory authorities, which decide whether to approve the medicine’s use by patients.

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What are clinical trials?

Clinical trials (or research studies) are a type of medical research in which people volunteer to take part. Clinical trials commonly study how potential medicines and other medical treatments affect the participants.

All medicines and vaccines that become available today for use in patients are first tested in clinical trials involving hundreds to thousands of people.

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What happens in a clinical trial?

What happens in a clinical trial depends on the ‘protocol.’ A protocol is a detailed plan that explains the purpose of the clinical trial and how it will be run. If you consider joining a clinical trial, these details will be explained to you as part of the informed consent process.

They include:

  • the length of the clinical trial
  • the study medicines, procedures, and tests in the clinical trial
  • the schedule of study activities
  • information about who can participate
  • how side effects will be tracked, managed, and reported
  • the rules that must be followed
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Who will oversee my care in a clinical trial? Can I continue to see my regular medical doctor?
  • As part of a clinical trial, your study-related medical care is provided by the study team at the location where you’re participating. This includes the principal investigator (or study doctor) — the healthcare professional who conducts and takes responsibility for the trial at that location — as well as other clinical study team members.
  • During your clinical trial, you may also continue to see your regular medical doctors for any care that is not related to the study. It is important for you to tell your study team about other conditions you might have, and to let them know which other doctors are caring for you. This helps the study team coordinate your overall care.
  • If you participate, the clinical trial will provide study-related medical care, and your regular medical doctors will address the other aspects of your health. Your regular medical doctors can also work with the study team to understand the details of the study and any impact it may have on your regular medical care.
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Are clinical trials safe?

All clinical trials have possible risks. The known and unknown risks of participating in a specific study will be explained to you during the informed consent process that happens before you decide whether to participate.

Clinical researchers must follow guidelines and regulatory requirements to help protect the rights, safety, and well-being of clinical trial participants. These include Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing and conducting clinical trials. There are also many entities that provide oversight of clinical trials.

These include health authorities or regulators, institutional review boards and independent ethics committees, and data safety and monitoring boards.

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Who can join a clinical trial?

We encourage everybody to consider joining clinical trials. There are many types of clinical trials that study different aspects of health in people with a variety of backgrounds and conditions. Each clinical trial has its own criteria for who may participate. These are called eligibility criteria.

Eligibility criteria include things like your age, sex, overall health, type of condition, and your medical treatment history. As part of the steps to join a clinical trial, the study doctor will confirm whether you meet all eligibility criteria and are able to participate.

Participation in a clinical trial is always voluntary. The decision to join is personal, and it is yours.

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Is there any cost to participate in a clinical trial?

Pfizer generally covers the cost of the study medicines and procedures that are part of our clinical trials.

Pfizer is also committed to reimbursing participants for reasonable clinical trial-related expenses such as transportation, parking, and meals. Because each study is different, we encourage you to ask the study team any questions you have. You can also refer to the informed consent document for the details about any costs for study participants and study-related reimbursement.

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