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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
EU CTIS ID: 2023-509762-38-00
What this study is testing
"- RSV_PreS4 group: to evaluate the humoral immune response following a single revaccination dose of RSVPreF3 OA vaccine given at pre-Season 4 - RSV_PreS5 group: to evaluate the humoral immune response following a single revaccination dose of RSVPreF3 OA vaccine given at pre-Season 5"
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- '- Male or female participants who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV_1dose group).
- "- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications). Note: In case of physical incapacity that would preclude the self-completion of the diary cards, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant’s health status while answering diaries or make decisions on behalf of the participant. Refer to Section 8 and Definition of Terms of the Clinical Study Protocol for the definition of caregiver. "
- "- Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure. "
- '- Participants who are medically stable in the opinion of the investigator at study entry. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.
You likely can't join if
- '- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
- '- Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions.
- '- Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination.
- '- Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study visit, or their planned use during the study period.
- '- Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study.
- '- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (For details on components of study intervention administered, refer to Arexvy SmPC/Prescribing information) [Arexvy Summary of Product Characteristics, 2023; Arexvy Prescribing Information, 2023].
See the full eligibility criteria
Who can join
- '- Male or female participants who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV_1dose group).
- "- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications). Note: In case of physical incapacity that would preclude the self-completion of the diary cards, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant’s health status while answering diaries or make decisions on behalf of the participant. Refer to Section 8 and Definition of Terms of the Clinical Study Protocol for the definition of caregiver. "
- "- Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure. "
- '- Participants who are medically stable in the opinion of the investigator at study entry. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.
What rules you out
- '- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
- '- Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions.
- '- Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination.
- '- Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study visit, or their planned use during the study period.
- '- Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study.
- '- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (For details on components of study intervention administered, refer to Arexvy SmPC/Prescribing information) [Arexvy Summary of Product Characteristics, 2023; Arexvy Prescribing Information, 2023].
- '- Hypersensitivity to latex.
- '- Serious or unstable chronic illness.
- '- Recurrent or un-controlled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g., completion of diary cards, attend regular phone calls/study site visits).
- '- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
- '- Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- '- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- "- Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures. Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant. "
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Republic of
- Russian Federation
- Canada
- New Zealand
- Australia
- South Africa
- Japan
- United Kingdom
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Republic of; Russian Federation; Canada; New Zealand; Australia and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.