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High Dose Quadrivalent Inactivated Influenza Vaccine for Infections

Vanderbilt University Medical Center, Nashville, TN
Infections+2 More ConditionsHigh Dose Quadrivalent Inactivated Influenza Vaccine - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial will test if two doses of a high-dose influenza vaccine are more effective than two doses of a standard dose influenza vaccine in lung transplant recipients.

Eligible Conditions
  • Immunization, Infection
  • Influenza
  • Transplant Infection

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Day 56 (post-vaccination)

Day 56 (post-vaccination)
Geometric Mean Titers Ratio of influenza vaccine antibodies (post-/pre-vaccination).
Geometric Mean Titers of influenza vaccine antibodies.
The number of participants achieving seroprotection and seroconversion for influenza virus.
Within 7 days post-vaccination
The number of participants reporting solicited injection site reactions and systemic reactions.

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine
1 of 2
Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine
1 of 2

Experimental Treatment

270 Total Participants · 2 Treatment Groups

Primary Treatment: High Dose Quadrivalent Inactivated Influenza Vaccine · No Placebo Group · Phase 2

Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine
Biological
Experimental Group · 1 Intervention: Standard Dose Quadrivalent Inactivated Influenza Vaccine · Intervention Types: Biological
Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine
Biological
Experimental Group · 1 Intervention: High Dose Quadrivalent Inactivated Influenza Vaccine · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 56 (post-vaccination)

Who is running the clinical trial?

Feinberg School of Medicine, Northwestern UniversityOTHER
33 Previous Clinical Trials
11,975 Total Patients Enrolled
1 Trials studying Infections
396 Patients Enrolled for Infections
Vanderbilt University Medical CenterLead Sponsor
798 Previous Clinical Trials
640,196 Total Patients Enrolled
13 Trials studying Infections
6,085 Patients Enrolled for Infections
Northwestern University Feinberg School of MedicineOTHER
35 Previous Clinical Trials
12,191 Total Patients Enrolled
1 Trials studying Infections
396 Patients Enrolled for Infections
University of WashingtonOTHER
1,633 Previous Clinical Trials
1,575,710 Total Patients Enrolled
40 Trials studying Infections
60,604 Patients Enrolled for Infections
Duke UniversityOTHER
2,235 Previous Clinical Trials
3,033,799 Total Patients Enrolled
26 Trials studying Infections
56,685 Patients Enrolled for Infections
University of Alabama at BirminghamOTHER
1,473 Previous Clinical Trials
2,245,863 Total Patients Enrolled
28 Trials studying Infections
48,224 Patients Enrolled for Infections
Natasha Halasa, MD. MPHPrincipal InvestigatorVanderbilt University Medical Center

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received a lung transplant.
References

Frequently Asked Questions

How many participants are currently being monitored for this clinical experiment?

"Affirmative, the clinicaltrials.gov database shows that this research is actively seeking to enroll participants. The study was first advertised on November 7th 2022 and its details have been updated most recently on November 18th of the same year. 270 individuals are needed for completion at one single site." - Anonymous Online Contributor

Unverified Answer

Are there still openings for participants to join this experiment?

"Affirmative. Clinicaltrials.gov data reveals that this study, first posted on November 7th 2022 is currently recruiting patients for enrollment. Approximately 270 subjects need to be enrolled from 1 particular medical centre." - Anonymous Online Contributor

Unverified Answer

Is High Dose Quadrivalent Inactivated Influenza Vaccine a secure method of immunization for patients?

"Taking into consideration the Phase 2 status of this High Dose Quadrivalent Inactivated Influenza Vaccine, our team at Power assigned it a rating of two out of three for safety due to existing data on its precautionary properties but lack thereof regarding efficacy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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