โšกYour ready-to-use recruitment solution: IRB-compliant, SEO-optimized website that automatically routes qualified patient leads to your clinical study (14-day free trial, then $44/mo)

NCT05947071RECRUITINGIRB Ready

High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients

(PSOT)

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 312 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs.

Who Can Participate

Inclusion Criteria

Male or female, 3-17 years of age at time of enrollment 2. Pediatric kidney, heart, and/or liver transplant recipient โ‰ฅ1 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 3. Anticipated to be available for duration of the study 4. Available by telephone, email, or text message

Exclusion Criteria

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 2. History of severe hypersensitivity to influenza vaccination or anaphylaxis to eggs/egg protein 3. History of severe latex hypersensitivity 4. History of Guillain-Barre syndrome 5. History of lung or intestine transplant 6. HIV positive pa

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

312 participants

๐ŸŽ‚

Age Range

3 Years - 17 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Stanford

California

Location available
View Stanford location page
RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

Kansas City

Missouri

Location available
View Kansas City location page
RECRUITING

Cincinnati

Ohio

Location available
View Cincinnati location page
RECRUITING

Pittsburgh

Pennsylvania

Location available
View Pittsburgh location page
RECRUITING

Nashville

Tennessee

Location available
View Nashville location page
RECRUITING

Houston

Texas

Location available
View Houston location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Organ Transplant Treatment in Stanford?

Join others in California exploring innovative treatment options through clinical research

Organ Transplant Treatment Options in Stanford, California

If you're searching for Organ Transplant treatment in Stanford, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Stanford, Atlanta, Chicago and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Organ Transplant. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 312 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Organ Transplant?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Organ Transplant

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Organ Transplant Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05947071. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.