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Comparison of Three Licensed Influenza Vaccines
Phase 4 trial testing FluBlok in Influenza in 413 participants. Completed in 30 June 2021.
| Lead sponsor | University of Rochester |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 413 |
| Start date | 28 October 2015 |
| Primary completion | 30 June 2020 |
| Estimated completion | 30 June 2021 |
| Sites | 1 location across United States |
University of Rochester
Adults 18 to 49, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean change of HAI serum antibody titers to A/California/07/09 (H1N1) using serum hemagglutination-inhibition (HAI) assay.
| Group | Value | 95% CI |
|---|---|---|
| FluBlok | 1937 | 636 – 3238 |
| Fluzone | 383 | 176 – 590 |
| FluCelVax | 607 | 370 – 845 |
Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using serum hemagglutination-inhibition (HAI) assay.
| Group | Value | 95% CI |
|---|---|---|
| FluBlok | 564 | 68 – 1059 |
| Fluzone | 420 | 137 – 703 |
| FluCelVax | 354 | 143 – 564 |
| Fluzone HD | 898 | 238 – 1557 |
Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2)
| Group | Value | 95% CI |
|---|---|---|
| FluBlok | 1733 | 655 – 2811 |
| Fluzone | 1711 | 450 – 2971 |
| FluCelVax | 799 | 221 – 1377 |
Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1) using Microneutralization (MN) assay.
| Group | Value | 95% CI |
|---|---|---|
| FluBlok | 2786 | 1390 – 4182 |
| Fluzone | 373 | 131 – 615 |
| FluCelVax | 881 | 477 – 1286 |
Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using Microneutralization (MN) assay.
| Group | Value | 95% CI |
|---|---|---|
| FluBlok | 1007 | 246 – 1769 |
| Fluzone | 554 | 104 – 1003 |
| FluCelVax | 308 | 94 – 710 |
| Fluzone HD | 1477 | 660 – 2293 |
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from pH1N1 HA using cytokine Elispot
| Group | Value | 95% CI |
|---|---|---|
| FluBlok | 71.2 | ± 97.4 |
| Fluzone | 21.4 | ± 57.3 |
| FluCelVax | 29.5 | ± 92.8 |
| Fluzone HD | 39.8 | ± 84.7 |
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from H3 HA using cytokine Elispot
| Group | Value | 95% CI |
|---|---|---|
| FluBlok | 93.2 | ± 128.0 |
| Fluzone | 14.0 | ± 69.8 |
| FluCelVax | 21.5 | ± 157.3 |
| Fluzone HD | 58.6 | ± 162.7 |
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from influenza B HA using cytokine Elispot.
| Group | Value | 95% CI |
|---|---|---|
| FluBlok | 178.0 | ± 218.8 |
| Fluzone | 89.2 | ± 162.1 |
| FluCelVax | 79.0 | ± 203.5 |
| Fluzone HD | 42.1 | ± 171.6 |
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from NP using cytokine Elispot.
| Group | Value | 95% CI |
|---|---|---|
| FluBlok | -23.9 | ± 81.3 |
| Fluzone | -9.7 | ± 95.5 |
| FluCelVax | -16.9 | ± 128.1 |
| Fluzone HD | 19.6 | ± 165.2 |
Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from M1 using cytokine Elispot.
| Group | Value | 95% CI |
|---|---|---|
| FluBlok | -18.9 | ± 99.7 |
| Fluzone | -18.7 | ± 118.0 |
| FluCelVax | 20.9 | ± 143.8 |
| Fluzone HD | -36.3 | ± 212.3 |
Time frame: 6 months. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | FluBlok | Fluzone | FluCelVax | Fluzone HD |
|---|---|---|---|---|---|
| Uri | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| sore throat | General disorders | — | — | — | — |
| sinusitis | Infections and infestations | — | — | — | — |
| headache | General disorders | — | — | — | — |
| back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| concussion | Nervous system disorders | — | — | — | — |
| urinary tract infection | Infections and infestations | — | — | — | — |
| influenza like illness | Infections and infestations | — | — | — | — |
| influenza | Infections and infestations | — | — | — | — |
| feverish | General disorders | — | — | — | — |
| fatigue | General disorders | — | — | — | — |
| gastrointestional illness | Gastrointestinal disorders | — | — | — | — |
| abdomina l pain | Gastrointestinal disorders | — | — | — | — |
| alopecia | Skin and subcutaneous tissue disorders | — | — | — | — |
| bilateral conjunctivities | Eye disorders | — | — | — | — |
| body aches | Musculoskeletal and connective tissue disorders | — | — | — | — |
| bronchitis | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| chest pain | Cardiac disorders | — | — | — | — |
| chills | General disorders | — | — | — | — |
| chipped tooth/dentral extraction | General disorders | — | — | — | — |
| strep throat | Infections and infestations | — | — | — | — |
| yeast infection | Infections and infestations | — | — | — | — |
| tooth infection | Infections and infestations | — | — | — | — |
| tooth ache | General disorders | — | — | — | — |
| otitis media | Infections and infestations | — | — | — | — |
| serous otitis | Infections and infestations | — | — | — | — |
| myalgia | General disorders | — | — | — | — |
| injection site bruise | Skin and subcutaneous tissue disorders | — | — | — | — |
| injection site erythema | Skin and subcutaneous tissue disorders | — | — | — | — |
| injection site hematoma | Skin and subcutaneous tissue disorders | — | — | — | — |
| injection site pain | Skin and subcutaneous tissue disorders | — | — | — | — |
| injection site swelling | Skin and subcutaneous tissue disorders | — | — | — | — |
| foot pain due to bone chip | Musculoskeletal and connective tissue disorders | — | — | — | — |
| fractured right thumb | Musculoskeletal and connective tissue disorders | — | — | — | — |
| knee replacement surgery | Musculoskeletal and connective tissue disorders | — | — | — | — |
| left wrist pain secondary to electric shock | Musculoskeletal and connective tissue disorders | — | — | — | — |
| left arm pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| left arm laceration | Musculoskeletal and connective tissue disorders | — | — | — | — |
| right ankle sprain | Musculoskeletal and connective tissue disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT03068949 adverse events section.
This study will evaluate in detail the way that the immune system responds to three different kinds of flu shots that are licensed in the United States.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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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/NCT03068949.
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