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Active not recruitingPHASE3INTERVENTIONAL

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

This research study is for people aged 60 and over who previously took part in an RSV vaccine study. It has a few important goals: Firstly, it wants to find out the best time to give a booster shot of the RSVPreF3 OA vaccine after the first dose. Secondly, researchers are keen to see how long the protection from a single dose of this vaccine lasts and to check its safety over five years. Finally, it gives participants who previously received a dummy treatment (a placebo) in the original study the chance to receive the actual RSVPreF3 OA vaccine, while also gathering more information about its safety.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
GlaxoSmithKline
Enrolment target
10,212
Start
01 Aug 2024
Estimated completion
30 Sep 2026

What is this study about?

You might have heard about Respiratory Syncytial Virus (RSV) because it can cause coughs, colds, and sometimes more serious chest infections, especially in older adults. This study is an important next step for a vaccine designed to protect against RSV, called RSVPreF3 OA. It's for people aged 60 and over, as this age group can be particularly vulnerable to severe RSV.

The main aim of this study is to learn more about how well and for how long the RSVPreF3 OA vaccine works. Researchers want to understand the ideal time for someone to get a second dose (a booster) to keep their protection strong. They will also be tracking participants for up to five years to see how long the initial protection lasts and to continue monitoring the vaccine's safety.

Another key part of this study is offering the RSVPreF3 OA vaccine to people who were in the original study but received a placebo, which is a dummy treatment without any active ingredients. This ensures that everyone who helped with the first research now has the opportunity to receive the potential protection, while also allowing the study team to gather even more valuable safety information.

Key takeaways

  • This study is for people aged 60+ who were in a previous RSV vaccine study.
  • It aims to find the best time for repeat RSV vaccinations.
  • Researchers will check how long the vaccine protects for (up to 5 years).
  • It offers the RSV vaccine to those who previously got a dummy treatment.
  • Participation involves follow-up appointments and health checks.
  • It contributes to understanding RSV protection in older adults.

Who may be eligible?

This study is specifically for people who have already taken part in an earlier RSV vaccine study called RSV OA=ADJ-006. You must be aged 60 or older. You could have either received the actual RSVPreF3 OA vaccine or a dummy treatment (placebo) in that previous study.

It's important that you are generally healthy enough to take part and can follow the study's instructions. This includes being able to attend appointments, use a phone or other communication, and keep track of things in a diary if needed. You also need to be able to understand and agree to what the study involves.

However, there are some reasons why you wouldn't be able to join. If you have an illness that affects your immune system, or if you've had a bad reaction to vaccines before, you wouldn't be suitable. Also, if you have a serious or unstable long-term illness, certain neurological problems, or any condition that a doctor thinks would make taking part unsafe or difficult, you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Were you previously in the RSV OA=ADJ-006 study?
  2. Are you 60 years old or older?
  3. Do you feel generally well and medically stable?
  4. Are you able to attend appointments and communicate with the study team?
  5. Do you NOT have a serious immune system problem or severe allergies to vaccine ingredients?
  6. Do you NOT have an unstable long-term illness or memory problems?
Answer every question to see your result.

What does participation involve?

If you join this study, it builds on your previous participation in the RSV OA=ADJ-006 study. You will likely continue to have contact with the study team, which could involve phone calls or visits to the study clinic. These visits are important for the team to check your health, see how you're feeling, and potentially give you a vaccine dose if you previously received the placebo. They will also collect information about your general health and any potential side effects. You might be asked to keep a diary of how you feel. The study aims to follow participants for up to five years (about 60 months) to understand the vaccine's long-term effects and safety.

Potential risks and benefits

By taking part, you could potentially benefit from receiving protection against RSV if you get the vaccine, or you might contribute to understanding how often a booster is needed for ongoing protection. However, as with any medical study, there are potential risks, such as temporary side effects from the vaccine like soreness or redness at the injection site, or feeling generally unwell. While rare, more serious reactions are always a possibility, and the study team will monitor you closely. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (249)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • GSK Investigational Site
    Verified postcode
    Birmingham, United States
  • GSK Investigational Site
    Verified postcode
    Birmingham, United States
  • GSK Investigational Site
    Verified postcode
    Huntsville, United States
  • GSK Investigational Site
    Verified postcode
    Phoenix, United States
  • GSK Investigational Site
    Verified postcode
    Tucson, United States
  • GSK Investigational Site
    Verified postcode
    Cerritos, United States
  • GSK Investigational Site
    Verified postcode
    Doral, United States
  • GSK Investigational Site
    Verified postcode
    Fort Myers, United States
  • GSK Investigational Site
    Verified postcode
    Jacksonville, United States
  • GSK Investigational Site
    Verified postcode
    Lake City, United States
  • GSK Investigational Site
    Verified postcode
    Melbourne, United States
  • GSK Investigational Site
    Verified postcode
    Miami, United States

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that can cause cold-like symptoms, but for older adults, it can sometimes lead to more serious breathing problems like bronchitis or pneumonia.

Who is this study for?

This study is for adults aged 60 or older who have previously taken part in another RSV vaccine study called RSV OA=ADJ-006.

What is the RSVPreF3 OA vaccine?

It's the specific vaccine being studied that is designed to protect against Respiratory Syncytial Virus.

Why is this study important?

It helps researchers learn more about how long the RSV vaccine protects people, when booster shots might be needed, and gathers more information about its safety over a longer period.

Will I get the actual vaccine if I join?

If you were in the previous study and received a dummy treatment (placebo), this study offers you the chance to receive the actual RSVPreF3 OA vaccine.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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