Immunization; InfectionPhase 2PSOTNCT05947071
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
A Phase 2 study testing Standard Dose Quadrivalent Inactivated Influenza Vaccine and High Dose Quadrivalent Inactivated Influenza Vaccine in people with Immunization; Infection and Transplantation Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Immunization; Infection, Transplantation Infection, Influenza
- What is being tested?
- Standard Dose Quadrivalent Inactivated Influenza Vaccine and High Dose Quadrivalent Inactivated Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 11 sitesUnited States
- Study dates
- 26 Sep 2024to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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 study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
ALEXANDRIA DRYER, 404-727-8237, alexandria.licht.dreyer@emory.edu
- Recruiting
Ann Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614
Molly Schnieders, 312-227-2061, mschnieders@luriechildrens.org
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
KERRIGAN PERKINS, 513-636-1882, Kerrigan.perkins@cchmc.edu
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Christopher Williams, 832-824-1580, cwillia4@bcm.edu
- Recruiting
Indiana University School of Medicine/Riley Hospital for Children
Indianapolis, Indiana, 46202
Kirsten Ryan, 317-944-5000, kramberg@iu.edu
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
MANDY MORGAN, 816-394-7545, mmmorgan@cmh.edu
- Recruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Haya Hayek, MBBS, 615-200-8479, haya.hayek@vumc.org
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Morgan Crowley, 610-888-7150, crowleym2@chop.edu
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
ISAAC CASON, 412-692-7351, casoni@upmc.edu
- Recruiting
Seattle Children's
Seattle, Washington, 98105
Zoe Munsey, 206-987-2000, Zoe.Munzoe.munsey@seattlechildrens.org
- Recruiting
Stanford University
Stanford, California, 94305
Hanqui Song, 415-806-1875, hanqui@stanford.edu
About this study
Official title: Comparison of High vs Standard Dose Influenza Vaccines in Pediatric Solid Organ Transplant Recipients
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. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined.
The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV.
Read the detailed description
Study design: This is a phase II, multi-center, double-blind, randomized controlled immunogenicity and safety trial comparing two doses of HD-QIV or two doses of SD-QIV in pediatric SOT recipients.
Hypotheses:
- Pediatric SOT recipients who are 1-23 months out from transplant and are administered two doses of HD-QIV will develop higher Hemagglutination Inhibition (HAI) geometric mean titer (GMT) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV, with Geometric Mean Titer Ratio (GMR) HD-QIV/SD-QIV greater than 1.0.
- Administration of HD-QIV in pediatric SOT recipients will be well tolerated and the safety profile will be similar to SD-QIV with regards to solicited local and systemic post-administration reactions.
- Baseline immunophenotypic markers of exhaustion, immune senescence, and immune activation at the pre-vaccine timepoint will correlate with post-vaccine HAI titers.
Study population: The study plans to enroll a total of approximately 312 pediatric heart, liver, and/or kidney transplant recipients between 1 and 23 months post-transplantation.
Study enrollment: The enrollment period will be over three-years. Participants will be randomized into one of two groups. Group 1 will receive two doses of SD-QIV (0.5 mL; 15μg of each influenza antigen) whereas Group 2 will receive two doses HD-QIV (0.7 mL; 60μg of each influenza antigen).
Influenza surveillance: Active surveillance for influenza-like symptoms will begin when influenza season starts in each site's community, defined in previous trials as identification of at least two positive respiratory tests for influenza, with at least 10% of diagnostic tests positive during two consecutive weeks in the local clinical or research laboratory. Enrollment will continue during influenza season with nasal swabs obtained at all main visits to document the occurrence of influenza virus both prior to and after vaccination. During the influenza season, the study staff will attempt to do a weekly telephone and/or electronic communication with the participants to detect and document any influenza-like illness (ILI) and any specific coronavirus disease of 2019 (COVID-19) like symptoms.
If participants meet ILI criteria and/or any specific coronavirus disease of 2019 (COVID-19) like symptoms (see below), an additional nasal swab will be collected*.
ILI criteria are met by occurrence of one of the conditions below:
- Fever: ≥38°C (100.4°F)
- Two or more of any of the following: respiratory symptoms (rhinorrhea, sinus congestion, post-nasal drip, shortness of breath, cough, wheezing, sputum production, sore throat, sneezing, watery eyes, ear pain, hoarseness); or systemic symptoms (myalgias, chills, chest pain, or headache); or new loss of taste or new loss of smell; or gastrointestinal symptoms (diarrhea or vomiting).
- Per investigators' discretion at each individual site, a swab is not needed if there is a known non-respiratory cause of symptoms.
- Being tested
- Standard Dose Quadrivalent Inactivated Influenza Vaccine, High Dose Quadrivalent Inactivated Influenza Vaccine
- Keywords
- Influenza, Vaccination, Immunization, High Dose, Fluzone, Standard Dose, Influenza, Human, Communicable Diseases, Pediatric transplantation
- Medical subject headings
- Infections, Influenza, Human, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Dose Quadrivalent Inactivated Influenza VaccineBiological
Also called Fluzone
Fluzone ® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by two influenza A subtype viruses and two type B viruses contained in the vaccine.
High Dose Quadrivalent Inactivated Influenza VaccineBiological
Also called Fluzone High Dose
Fluzone High-Dose (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphatebuffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration.
| Study group | Role | What they receive |
|---|---|---|
| Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine | Experimental | Two doses of SD-QIV (0.5 mL; 15µg of each influenza antigen) 28-42 days apart Receives: Biological: Standard Dose Quadrivalent Inactivated Influenza Vaccine |
| Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine | Experimental | Two doses of HD-QIV (0.7 mL; 60µg of each influenza antigen) 28-42 days apart Receives: Biological: High Dose Quadrivalent Inactivated Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: Hemagglutination Inhibition (HAI) titers
Antibody titers will be measured by hemagglutination inhibition assay.
Measured: 4 weeks following the 2nd study vaccine
Safety: solicited local and systemic post-administration reactions
Post-vaccination local adverse events (pain, tenderness, swelling/induration, erythema/redness, swelling/induration size, and erythema/redness size) and systemic adverse events (Fatigue/malaise, headache, nausea, body ache/myalgia (not at the injection site), general activity level, vomiting, and fever).
Measured: in the first 7 days following each study vaccine
Secondary outcomes (3)
Immunogenicity: Hemagglutination Inhibition (HAI) titers
Antibody titers will be measured by hemagglutination inhibition assay.
Measured: 4 weeks following 1st and 2nd doses of each study vaccine
The number of participants achieving seroprotection and seroconversion for influenza virus.
Antibody titers will be measured by hemagglutination inhibition assay. Seroconversion is defined as ≥ 4-fold rise in hemagglutination inhibition assay titers. Seroprotection is defined as ≥1:40 hemagglutination inhibition assay titer.
Measured: 4 weeks following the 1st and 2nd study vaccination
Durability of immunogenicity
Measured as Hemagglutination Inhibition (HAI) titer at end of season
Measured: 180 days after vaccine 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start26 Sep 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunization; InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary goal of this two-arm, double blind, randomized controlled trial is to compare influenza vaccine immunogenicity and safety between (a) two doses of SD-QIV and (b) two doses of HD-QIV over one influenza season in a population of pediatric SOT recipients who are ≥1 month and \<24 months post-transplant at the time of study immunization.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947071
- Sponsor's protocol ID
- DAIT RTB-019
- Acronym
- PSOT
- Status last verified
- Oct 2026
- First submitted
- 1 Mar 2023
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High vs Standard Dose Influenza Vaccines in Pediatric Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT05947071
- Acronym / sponsor ID
- PSOT / DAIT RTB-019
- Keywords
- Influenza, Vaccination, Immunization, High Dose, Fluzone, Standard Dose, Influenza, Human, Communicable Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined.
The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV.
Detailed description
Study design: This is a phase II, multi-center, double-blind, randomized controlled immunogenicity and safety trial comparing two doses of HD-QIV or two doses of SD-QIV in pediatric SOT recipients.
Hypotheses:
- Pediatric SOT recipients who are 1-23 months out from transplant and are administered two doses of HD-QIV will develop higher Hemagglutination Inhibition (HAI) geometric mean titer (GMT) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV, with Geometric Mean Titer Ratio (GMR) HD-QIV/SD-QIV greater than 1.0.
- Administration of HD-QIV in pediatric SOT recipients will be well tolerated and the safety profile will be similar to SD-QIV with regards to solicited local and systemic post-administration reactions.
- Baseline immunophenotypic markers of exhaustion, immune senescence, and immune activation at the pre-vaccine timepoint will correlate with post-vaccine HAI titers.
Study population: The study plans to enroll a total of approximately 312 pediatric heart, liver, and/or kidney transplant recipients between 1 and 23 months post-transplantation.
Study enrollment: The enrollment period will be over three-years. Participants will be randomized into one of two groups. Group 1 will receive two doses of SD-QIV (0.5 mL; 15μg of each influenza antigen) whereas Group 2 will receive two doses HD-QIV (0.7 mL; 60μg of each influenza antigen).
Influenza surveillance: Active surveillance for influenza-like symptoms will begin when influenza season starts in each site's community, defined in previous trials as identification of at least two positive respiratory tests for influenza, with at least 10% of diagnostic tests positive during two consecutive weeks in the local clinical or research laboratory. Enrollment will continue during influenza season with nasal swabs obtained at all main visits to document the occurrence of influenza virus both prior to and after vaccination. During the influenza season, the study staff will attempt to do a weekly telephone and/or electronic communication with the participants to detect and document any influenza-like illness (ILI) and any specific coronavirus disease of 2019 (COVID-19) like symptoms.
If participants meet ILI criteria and/or any specific coronavirus disease of 2019 (COVID-19) like symptoms (see below), an additional nasal swab will be collected*.
ILI criteria are met by occurrence of one of the conditions below:
- Fever: ≥38°C (100.4°F)
- Two or more of any of the following: respiratory symptoms (rhinorrhea, sinus congestion, post-nasal drip, shortness of breath, cough, wheezing, sputum production, sore throat, sneezing, watery eyes, ear pain, hoarseness); or systemic symptoms (myalgias, chills, chest pain, or headache); or new loss of taste or new loss of smell; or gastrointestinal symptoms (diarrhea or vomiting).
- Per investigators' discretion at each individual site, a swab is not needed if there is a known non-respiratory cause of symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The primary goal of this two-arm, double blind, randomized controlled trial is to compare influenza vaccine immunogenicity and safety between (a) two doses of SD-QIV and (b) two doses of HD-QIV over one influenza season in a population of pediatric SOT recipients who are ≥1 month and <24 months post-transplant at the time of study immunization.
| Arm | Type | Receives |
|---|---|---|
| Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine | Experimental | Biological: Standard Dose Quadrivalent Inactivated Influenza VaccineTwo doses of SD-QIV (0.5 mL; 15µg of each influenza antigen) 28-42 days apart |
| Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine | Experimental | Biological: High Dose Quadrivalent Inactivated Influenza VaccineTwo doses of HD-QIV (0.7 mL; 60µg of each influenza antigen) 28-42 days apart |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
- Anticipated to be available for duration of the study
- Available by telephone, email, or text message
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Dose Quadrivalent Inactivated Influenza VaccineAlso: FluzoneFluzone ® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by two influenza A subtype viruses and two type B viruses contained in the vaccine. | Biological | Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine |
| High Dose Quadrivalent Inactivated Influenza VaccineAlso: Fluzone High DoseFluzone High-Dose (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphatebuffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. | Biological | Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine |
Primary outcome
Immunogenicity: Hemagglutination Inhibition (HAI) titers
Time frame: 4 weeks following the 2nd study vaccine
Antibody titers will be measured by hemagglutination inhibition assay.
Safety: solicited local and systemic post-administration reactions
Time frame: in the first 7 days following each study vaccine
Post-vaccination local adverse events (pain, tenderness, swelling/induration, erythema/redness, swelling/induration size, and erythema/redness size) and systemic adverse events (Fatigue/malaise, headache, nausea, body ache/myalgia (not at the injection site), general activity level, vomiting, and fever).
3 secondary outcomes
Immunogenicity: Hemagglutination Inhibition (HAI) titers
Time frame: 4 weeks following 1st and 2nd doses of each study vaccine
The number of participants achieving seroprotection and seroconversion for influenza virus.
Time frame: 4 weeks following the 1st and 2nd study vaccination
Durability of immunogenicity
Time frame: 180 days after vaccine 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Robert H. Lurie Children's Hospital of Chicago
Chicago, United States
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Dose Quadrivalent Inactivated Influenza Vaccine and High Dose Quadrivalent Inactivated Influenza Vaccine in people with Immunization; Infection and Transplantation Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity: Hemagglutination Inhibition (HAI) titers (time frame: 4 weeks following the 2nd study vaccine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.