Who is sponsoring NCT03179761?

NCT03179761 is sponsored by Vanderbilt-Ingram Cancer Center.

What drugs are being tested in NCT03179761?

Interventions in NCT03179761: Quadrivalent Inactivated Influenza Vaccine, Laboratory Biomarker Analysis, Trivalent Influenza Vaccine.

What condition does NCT03179761 study?

NCT03179761 studies Hematopoietic Cell Transplantation.

Is NCT03179761 still recruiting?

NCT03179761 is currently completed. Last updated 4 December 2024.

Are results published for NCT03179761?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-12-04 · How we verify

NCT03179761

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients

Completed Phase 2 Results posted Last updated 4 December 2024

What this trial tests

Phase 2 trial testing Quadrivalent Inactivated Influenza Vaccine in Hematopoietic Cell Transplantation in 124 participants. Completed in 1 October 2024.

Timeline

9 October 2017

Primary endpoint
15 February 2022

1 October 2024

Quick facts

Lead sponsor	Vanderbilt-Ingram Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	124
Start date	9 October 2017
Primary completion	15 February 2022
Estimated completion	1 October 2024
Sites	4 locations across United States

Drugs / interventions tested

Quadrivalent Inactivated Influenza Vaccine — full drug profile →
Laboratory Biomarker Analysis — full drug profile →
Trivalent Influenza Vaccine — full drug profile →

Conditions studied

Hematopoietic Cell Transplantation — all drugs for Hematopoietic Cell Transplantation →

Sponsor

Vanderbilt-Ingram Cancer Center — full company profile →

Who can join

18 and older, any sex, with Hematopoietic Cell Transplantation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity Primary · Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.

Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza A antigens.

A/H1N1 Visit 2 GMT ≥1:40

Group	Value	95% CI
Group I (HD-TIV)	0.62	0.49 – 0.73
Group 2 (SD-QIV)	0.59	0.46 – 0.70

A/H1N1 Visit 2 GMFR ≥ 4-Fold Rise

Group	Value	95% CI
Group I (HD-TIV)	0.23	0.14 – 0.35
Group 2 (SD-QIV)	0.25	0.16 – 0.37

A/H1N1 Visit 3 GMT ≥1:40

Group	Value	95% CI
Group I (HD-TIV)	0.75	0.63 – 0.84
Group 2 (SD-QIV)	0.73	0.61 – 0.84

A/H1N1 Visit 3 GMFR ≥ 4-Fold Rise

Group	Value	95% CI
Group I (HD-TIV)	0.41	0.29 – 0.53
Group 2 (SD-QIV)	0.39	0.27 – 0.52

A/H1N1 Visit 4 GMT ≥1:40

Group	Value	95% CI
Group I (HD-TIV)	0.66	0.53 – 0.78
Group 2 (SD-QIV)	0.65	0.51 – 0.78

A/H1N1 Visit 4 GMFR ≥ 4-Fold Rise

Group	Value	95% CI
Group I (HD-TIV)	0.34	0.22 – 0.47
Group 2 (SD-QIV)	0.35	0.22 – 0.49

A/H3N2 Visit 2 GMT ≥1:40

Group	Value	95% CI
Group I (HD-TIV)	0.65	0.52 – 0.76
Group 2 (SD-QIV)	0.60	0.48 – 0.72

A/H3N2 Visit 2 GMFR ≥ 4-Fold Rise

Group	Value	95% CI
Group I (HD-TIV)	0.32	0.21 – 0.44
Group 2 (SD-QIV)	0.19	0.11 – 0.30

HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity Secondary · Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.

B/Victoria Visit 2 GMT ≥1:40

Group	Value	95% CI
Group I (HD-TIV)	0.73	0.61 – 0.83
Group 2 (SD-QIV)	0.79	0.68 – 0.88

B/Victoria Visit 2 GMFR ≥ 4-Fold Rise

Group	Value	95% CI
Group I (HD-TIV)	0.25	0.15 – 0.37
Group 2 (SD-QIV)	0.17	0.09 – 0.28

B/Victoria Visit 3 GMT ≥1:40

Group	Value	95% CI
Group I (HD-TIV)	0.92	0.83 – 0.97
Group 2 (SD-QIV)	0.86	0.75 – 0.93

B/Victoria Visit 3 GMFR ≥ 4-Fold Rise

Group	Value	95% CI
Group I (HD-TIV)	0.44	0.32 – 0.57
Group 2 (SD-QIV)	0.29	0.18 – 0.41

B/Victoria Visit 4 GMT ≥1:40

Group	Value	95% CI
Group I (HD-TIV)	0.83	0.71 – 0.91
Group 2 (SD-QIV)	0.73	0.60 – 0.84

B/Victoria Visit 4 GMFR ≥ 4-Fold Rise

Group	Value	95% CI
Group I (HD-TIV)	0.34	0.22 – 0.47
Group 2 (SD-QIV)	0.18	0.09 – 0.31

B/Yamagata Visit 2 GMT ≥1:40

Group	Value	95% CI
Group I (HD-TIV)	0.72	0.60 – 0.82
Group 2 (SD-QIV)	0.87	0.78 – 0.94

B/Yamagata Visit 2 GMFR ≥ 4-Fold Rise

Group	Value	95% CI
Group I (HD-TIV)	0.07	0.02 – 0.15
Group 2 (SD-QIV)	0.22	0.13 – 0.33

Solicited Local Injection Site Adverse Events Secondary · Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.

The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol. Solicited injection site AEs included: pain, tenderness, erythema/redness, and swelling/induration. The diameter of any erythema/redness and swelling/induration was measured to evaluate "redness size" and "swelling size."

Vaccine 1 - Pain

Group	Value	95% CI
Group I (HD-TIV)	0.250	0.147 – 0.379
Group 2 (SD-QIV)	0.156	0.078 – 0.269

Vaccine 1 - Tenderness

Group	Value	95% CI
Group I (HD-TIV)	0.383	0.261 – 0.518
Group 2 (SD-QIV)	0.297	0.189 – 0.424

Vaccine 1 - Redness size

Group	Value	95% CI
Group I (HD-TIV)	0.067	0.018 – 0.162
Group 2 (SD-QIV)	0.047	0.010 – 0.131

Vaccine 1 - Swelling

Group	Value	95% CI
Group I (HD-TIV)	0.117	0.048 – 0.226
Group 2 (SD-QIV)	0.094	0.035 – 0.193

Vaccine 1 - Swelling size

Group	Value	95% CI
Group I (HD-TIV)	0.100	0.038 – 0.205
Group 2 (SD-QIV)	0.063	0.017 – 0.152

Vaccine 2 - Pain

Group	Value	95% CI
Group I (HD-TIV)	0.254	0.150 – 0.384
Group 2 (SD-QIV)	0.169	0.084 – 0.290

Vaccine 2 - Tenderness

Group	Value	95% CI
Group I (HD-TIV)	0.458	0.327 – 0.592
Group 2 (SD-QIV)	0.288	0.178 – 0.421

Vaccine 2 - Redness size

Group	Value	95% CI
Group I (HD-TIV)	0.102	0.038 – 0.208
Group 2 (SD-QIV)	0.000	0.000 – 0.061

Solicited Systemic Adverse Events Secondary · Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.

The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol. Solicited systemic AEs included: fevers, fatigue/malaise, headache, nausea, body ache/myalgia, generally activity, and vomiting.

Vaccine 1 - Fever

Group	Value	95% CI
Group I (HD-TIV)	0.033	0.004 – 0.115
Group 2 (SD-QIV)	0.031	0.004 – 0.108

Vaccine 1 - Fatigue

Group	Value	95% CI
Group I (HD-TIV)	0.350	0.231 – 0.484
Group 2 (SD-QIV)	0.313	0.202 – 0.441

Vaccine 1 - Headache

Group	Value	95% CI
Group I (HD-TIV)	0.267	0.161 – 0.397
Group 2 (SD-QIV)	0.188	0.101 – 0.305

Vaccine 1 - Nausea

Group	Value	95% CI
Group I (HD-TIV)	0.083	0.028 – 0.184
Group 2 (SD-QIV)	0.172	0.089 – 0.287

Vaccine 1 - Myalgia

Group	Value	95% CI
Group I (HD-TIV)	0.200	0.108 – 0.323
Group 2 (SD-QIV)	0.172	0.089 – 0.287

Vaccine 1 - General Activity

Group	Value	95% CI
Group I (HD-TIV)	0.300	0.188 – 0.432
Group 2 (SD-QIV)	0.297	0.189 – 0.424

Vaccine 1 - Vomiting

Group	Value	95% CI
Group I (HD-TIV)	0.017	0.000 – 0.089
Group 2 (SD-QIV)	0.063	0.017 – 0.152

Vaccine 2 - Fever

Group	Value	95% CI
Group I (HD-TIV)	0.034	0.004 – 0.117
Group 2 (SD-QIV)	0.068	0.019 – 0.165

Percentage of Individuals in Each Group That Test Positive for Influenza by PCR Secondary · Nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration of the study.

The percentage of breakthrough flu in vaccinated participants, separated by treatment group.

Group	Value	95% CI
Group I (HD-TIV)	5
Group 2 (SD-QIV)	2

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group I (HD-TIV)

Serious: 4/60 (7%)

Deaths: 2/60

Group 2 (SD-QIV)

Serious: 0/64 (0%)

Deaths: 5/64

Serious adverse events (4 terms)

Reaction	System	Group I (HD-TIV)	Group 2 (SD-QIV)
Pneumonia	Infections and infestations	—	—
Diarrhea	Gastrointestinal disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Viral illness	Infections and infestations	—	—

Other adverse events (11 terms — click to expand)

Reaction	System	Group I (HD-TIV)	Group 2 (SD-QIV)
Tenderness	General disorders	—	—
Decreased general activity	General disorders	—	—
Fatigue	General disorders	—	—
Pain	General disorders	—	—
Headache	General disorders	—	—
Myalgia/ Body aches	General disorders	—	—
Nausea	General disorders	—	—
Swelling	Skin and subcutaneous tissue disorders	—	—
Redness/ Erythema	Skin and subcutaneous tissue disorders	—	—
Fever	General disorders	—	—
Vomiting	General disorders	—	—

Most-reported serious reactions: Pneumonia, Diarrhea, Atrial fibrillation, Viral illness.

Data from ClinicalTrials.gov NCT03179761 adverse events section.

Sponsor's own description

This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or standard-dose quadrivalent inactivated influenza and how well they work in treating adult patients undergoing stem cell transplant. Season influenza can cause more severe infections in patients who have had a stem cell transplant since their immune system doesn't work as well. Influenza vaccine may provide better protection against flu in adults.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Community-Acquired Respiratory Viruses in Transplant Patients: Diversity, Impact, Unmet Clinical Needs.
Ison MG, Hirsch HH. · · 2019 · cited 76× · PMID 31511250 · DOI 10.1128/cmr.00042-19
The Importance of Advancing Severe Acute Respiratory Syndrome Coronavirus 2 Vaccines in Children.
Kao CM, Orenstein WA, Anderson EJ. · · 2021 · cited 27× · PMID 33527122 · DOI 10.1093/cid/ciaa712
Comparison of Two High-Dose Versus Two Standard-Dose Influenza Vaccines in Adult Allogeneic Hematopoietic Cell Transplant Recipients.
Thomas LD, Batarseh E, Hamdan L, Haddadin Z, et al · · 2023 · cited 8× · PMID 39219510 · DOI 10.1093/cid/ciad458

Verify or expand the search:

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Currently open trials in the same condition.

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Other Vanderbilt-Ingram Cancer Center trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03179761 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center
Last refreshed: 4 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03179761.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing