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Virus Therapy
High vs. Standard Dose Flu Vaccine for Transplant Patients (PSOT Trial)
Phase 2
Waitlist Available
Led By Natasha Halasa, MD. MPH
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days after vaccine 2
Awards & highlights
PSOT Trial Summary
This trial aims to find out what's the best vaccine strategy for pediatric organ transplant patients to prevent influenza virus infections.
Who is the study for?
This trial is for pediatric solid organ transplant recipients aged 3-17, within 1 to 24 months post-transplant. It includes those who've had kidney, heart, or liver transplants and are available for the study duration. Excluded are patients with recent immune treatments, severe allergies, HIV positive status, pregnancy/lactation in females of childbearing age without a negative pregnancy test prior to each vaccine dose.Check my eligibility
What is being tested?
The trial tests whether two doses of High Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV) provide better immune response compared to Standard Dose (SD) in children who have received an organ transplant less than two years ago. The safety and increase in protective antibodies will be measured.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions to vaccines such as soreness at injection site, fever, fatigue or allergic reactions. Since it's a high-dose vaccine being tested on immunocompromised children, monitoring for any unusual side effects will be crucial.
PSOT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days after vaccine 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days after vaccine 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety: solicited local and systemic post-administration reactions
Secondary outcome measures
Durability of immunogenicity
Immunogenicity: Hemagglutination Inhibition (HAI) titers
The number of participants achieving seroprotection and seroconversion for influenza virus.
PSOT Trial Design
2Treatment groups
Experimental Treatment
Group I: Two Doses Standard Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention
Two doses of SD-QIV (0.5 mL; 15µg of each influenza antigen) 28-42 days apart
Group II: Two Doses High Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention
Two doses of HD-QIV (0.7 mL; 60µg of each influenza antigen) 28-42 days apart
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,157 Total Patients Enrolled
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Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
671,880 Total Patients Enrolled
14 Trials studying Infections
5,781 Patients Enrolled for Infections
Children's Hospital Medical Center, CincinnatiOTHER
815 Previous Clinical Trials
6,531,284 Total Patients Enrolled
10 Trials studying Infections
3,534 Patients Enrolled for Infections
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a lung or intestine transplant.I have had Guillain-Barre syndrome in the past.I have received this season's flu vaccine after my transplant.I am not pregnant or breastfeeding.I am between 3 and 17 years old.I received a kidney, heart, or liver transplant between 1 month and 2 years ago.I have received a transplant for my kidney, heart, or liver.I am eligible for another organ transplant.I can be reached by phone, email, or text.
Research Study Groups:
This trial has the following groups:- Group 1: Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine
- Group 2: Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the criteria for becoming a participant in this research endeavor?
"Qualified participants must be between 3 and 17 years old, display signs of infection, and comprise a total sample size of 312 individuals."
Answered by AI
Has the Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine been affirmed by the FDA?
"Due to the Phase 2 status of Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine, it was given a safety rating of 2 as there is evidence for its safety but not yet any data that suggests efficacy."
Answered by AI
Does this medical research accept participants aged 35 or above?
"The research protocol stipulates that patients aged 3 to 17 are qualified for inclusion in this clinical trial. As per the records, there 230 studies conducted on minors while 680 have been carried out with elderly persons."
Answered by AI
Are there any vacancies for this medical trial?
"According to clinicaltrials.gov, this research initiative is not presently looking for participants - it was first listed on September 1st 2023 and last altered on July 11th 2023. Nevertheless, there are 902 other medical studies actively recruiting members at the moment."
Answered by AI
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