Respiratory Syncytial Virus study: RSVpreF
Official title Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
ClinicalTrials.gov ID: NCT07839871
What this study is testing
What is RSVpreF?
RSVpreF is an investigational medicine, being studied as a potential treatment for respiratory syncytial virus (rsv).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of RSVpreF in children 5 to \<18 years of age at high risk for RSV disease, including those who are immunocompromised.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 17. Healthy volunteers may be eligible.
You may be able to join if
- Participants' age requirements for each study cohort at enrollment, respectively Cohort 1a (chronic medical conditions) 12 to \<18 years of age...
- Cystic fibrosis
- Medically treated asthma
- Other chronic respiratory diseases and malformations of the lung
- Trisomy 21 (Down syndrome)
You likely can't join if
- Applicable to Cohort 1 (a and b) participants only: Immunocompromised individuals with known or suspected immunodeficiency, as determined by history...
- Applicable to Cohort 1 (a and b) participants only: Individuals with a history of autoimmune disease, past or present, requiring therapeutic...
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study...
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular...
- Individuals with epilepsy or other seizure disorders that is uncontrolled/unstable, or a history of seizures and/or other neurological complications...
- History of Guillain-Barré syndrome and/or acute polyneuropathy without an underlying etiology.
See the full eligibility criteria
- Participants' age requirements for each study cohort at enrollment, respectively Cohort 1a (chronic medical conditions) 12 to \<18 years of age Cohort 1b (chronic medical conditions) 5 to \<12 years of age Cohort 2a...
- Cystic fibrosis
- Medically treated asthma
- Other chronic respiratory diseases and malformations of the lung
- Trisomy 21 (Down syndrome)
- Neuromuscular disease
- Cerebral palsy
- Hemodynamically significant or symptomatic congenital heart disease
- Sickle cell disease
- Immunomodulatory therapy: Is on an active immunosuppressive (including cytotoxic) or immunomodulatory therapy at a stable dose.
- Primary immune deficiency: Has a diagnosed primary immunodeficiency disease OR
- Cellular therapy: Has received a bone marrow or stem cell transplant at least 6 months (180 days) prior to enrollment with adequate immune reconstitution for immunization in the investigator's opinion or has received...
- Solid organ transplant: Has received a solid organ transplant at least 3 months prior and with no acute rejection episodes within 90 days prior to enrollment and is on ongoing immunosuppressive therapy OR
- End-stage renal disease: Has end-stage renal disease (ESRD) on hemodialysis (HD)
- Participants' weight must be: Cohort 1a: ≥30.0 kg at enrollment Cohort 1b: ≥14.5 kg at enrollment Cohort 2a : ≥30 kg at enrollment Cohort 2b: ≥14.5 kg at enrollment The participant's parent(s)/legal guardian is capable...
- Applicable to Cohort 1 (a and b) participants only: Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination
- Applicable to Cohort 1 (a and b) participants only: Individuals with a history of autoimmune disease, past or present, requiring therapeutic intervention including, but not limited to, systemic lupus erythematosus.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
- Individuals with epilepsy or other seizure disorders that is uncontrolled/unstable, or a history of seizures and/or other neurological complications following vaccination
- History of Guillain-Barré syndrome and/or acute polyneuropathy without an underlying etiology.
- Individuals who are pregnant
- Any medical or psychiatric condition, including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality, that may increase the risk of study participation or, in...
The study team makes the final eligibility decision.
Where it is enrolling
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- South Euclid, Ohio, United States
- Seattle, Washington, United States
- Maebashi, Gunma, Japan
- Midori, Saitama, Japan
- Chuo-ku, Tokyo, Japan
- Dziekanów Leśny, Poland
- Krakow, Poland
- Madrid, Madrid, Comunidad de, Spain
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, but 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, 5 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Durham, North Carolina, United States; Cincinnati, Ohio, United States; South Euclid, Ohio, United States; Seattle, Washington, United States; Maebashi, Gunma, Japan; Midori, Saitama, Japan and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.