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New treatment option for Immunization; Infection
Official title High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
ClinicalTrials.gov ID: NCT05947071
What this study is testing
What is Standard Dose Quadrivalent Inactivated Influenza Vaccine?
Standard Dose Quadrivalent Inactivated Influenza Vaccine is an investigational medicine, given as an once-weekly, being studied as a potential treatment for immunization; infection.
Also referred to as Fluzone.
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
- Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 17
You may be able to join if
- Male or female, 3-17 years of age at time of enrollment
- Pediatric kidney, heart, and/or liver transplant recipient ≥1 month and \<24 months post-transplant at the time of study immunization
- Note: Inclusion of recipients of multiple organs is permitted but is limited to recipients of any combination of organs including kidney, heart...
- Note: Participants undergoing re-transplantation are permitted
- Anticipated to be available for duration of the study
You likely can't join if
- Inability (i.e. not able to understand and provide consent) or unwillingness of a participant/parent/legal guardian to give written informed consent...
- History of severe hypersensitivity to influenza vaccination or anaphylaxis to eggs/egg protein
- History of severe latex hypersensitivity
- History of Guillain-Barre syndrome
- History of lung or intestine transplant
- HIV positive patients (testing within 24 months of enrollment)
See the full eligibility criteria
- Male or female, 3-17 years of age at time of enrollment
- Pediatric kidney, heart, and/or liver transplant recipient ≥1 month and \<24 months post-transplant at the time of study immunization
- Note: Inclusion of recipients of multiple organs is permitted but is limited to recipients of any combination of organs including kidney, heart and/or liver
- Note: Participants undergoing re-transplantation are permitted
- Anticipated to be available for duration of the study
- Available by telephone, email, or text message
- Inability (i.e. not able to understand and provide consent) or unwillingness of a participant/parent/legal guardian to give written informed consent or comply with study protocol
- History of severe hypersensitivity to influenza vaccination or anaphylaxis to eggs/egg protein
- History of severe latex hypersensitivity
- History of Guillain-Barre syndrome
- History of lung or intestine transplant
- HIV positive patients (testing within 24 months of enrollment)
- Receipt of current season's influenza vaccine post-transplant prior to enrollment in the study
- Currently pregnant or lactating (females of childbearing age may be enrolled based on self-report, urine pregnancy test must be performed prior to each influenza vaccine)
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Kansas City, Missouri, United States
- Cincinnati, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
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, 3 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Kansas City, Missouri, United States; Cincinnati, Ohio, United States; Pittsburgh, Pennsylvania, United States and 2 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 ClinicalTrials.gov; the study team decides eligibility.