Trial · NCT05044195
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
NCT05044195, Phase 3, Completed, Seqirus; results first posted 2023-09-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age. Trials, record NCT05044195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05044195
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
- NCT number
- NCT05044195
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,044 participants, actual
- Lead sponsor
- Seqirus
- Conditions
- Influenza, Human
- Interventions
- aQIV, Comparator QIV
- First posted
- 2021-09-14
- Last updated
- 2023-09-28
- Results first posted
- 2023-09-28
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 22 | The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV. |
| Primary | Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 22 | The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. The SCR difference is defined as the Comparator QIV SCR minus the aQIV SCR. |
| Primary | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 22 | The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV. |
| Secondary | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 181 | The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV. |
| Secondary | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | GMTs on Day 1 (prior to vaccination), Day 22 (3 weeks after vaccination), and Day 181 (6 months after vaccination) as determined by HI assay against each of the four vaccine strains |
| Secondary | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | The GMFI is defined as the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer. |
| Secondary | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | Percentage of subjects with a titer ≥1:40 on Day 1, Day 22, and Day 181 as determined by HI assay against each of the four vaccine strains |
| Secondary | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22 or Day 181) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. |
| Secondary | Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Day 1 through Day 7 | Number and percentage of subjects with solicited local and systemic AEs occurring for 7 days following vaccination |
| Secondary | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Day 1 through Day 22 | The percentage of subjects with at least one unsolicited AE occurring 21 days following vaccination The severity of AEs is based on the maximum severity associated with a Preferred Term for a reported AE. Related AEs include possibly related AEs, probably related AEs and AEs with missing relatedness assessment. The severity and relatedness of AEs were determined by the investigator. For the any AE summary by severity, a subject with multiple AEs is counted according to the highest severity of their reported AEs. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 22 | Per Protocol Set (PPS) Immunogenicity, defined as all subjects in the Full Analysis Set (FAS) Immunogenicity who: had both Day 1 and Day 22 immunogenicity assessment; correctly received the vaccine (ie, received the vaccine to which the subjects were randomized and at the scheduled time points); had no protocol deviations leading to exclusion as defined prior to unblinding/analysis; were not excluded due to other reasons defined prior to unblinding or analysis. Note: Adjusted GMTs are presented. | Titer | GEOMETRIC_MEAN |
| PRIMARY | Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 22 | PPS Immunogenicity | percentage of participants | NUMBER |
| PRIMARY | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 22 | FAS Immunogenicity, defined as all subjects in the All Enrolled Set who were randomized, received study vaccination and provided immunogenicity data at any time point. Note: Adjusted GMTs are presented. | Titer | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 181 | FAS Immunogenicity. Note: Adjusted GMTs are presented. | Titer | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | FAS Immunogenicity. Note: Unadjusted GMTs are presented. | Titer | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | FAS Immunogenicity | Fold Increase | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | FAS Immunogenicity | percentage of participants | NUMBER |
| SECONDARY | Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Day 1 to Day 181 | FAS Immunogenicity | percentage of participants | NUMBER |
| SECONDARY | Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination | Day 1 through Day 7 | Solicited Safety Set, defined as all subjects in the All Exposed Set with any solicited AE data including temperature measurements or use of analgesics/antipyretics | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination | Day 1 through Day 22 | Unsolicited Safety Set, defined as all subjects in the All Exposed Set with any unsolicited AE data. Note: Subjects are categorized according to the maximum symptom severity. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group188
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | aQIV | A/H1N1 | 731.90 | 95% Confidence Interval 689.39 to 777.04 | Titer |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Comparator QIV | A/H1N1 | 586.85 | 95% Confidence Interval 552.83 to 622.96 | Titer |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | aQIV | A/H3N2 | 347.89 | 95% Confidence Interval 324.78 to 372.64 | Titer |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Comparator QIV | A/H3N2 | 313.16 | 95% Confidence Interval 292.42 to 335.36 | Titer |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | aQIV | B/Yamagata | 154.40 | 95% Confidence Interval 146.80 to 162.40 | Titer |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Comparator QIV | B/Yamagata | 145.74 | 95% Confidence Interval 138.57 to 153.27 | Titer |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | aQIV | B/Victoria | 144.41 | 95% Confidence Interval 136.97 to 152.26 | Titer |
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Comparator QIV | B/Victoria | 143.32 | 95% Confidence Interval 135.97 to 151.07 | Titer |
| Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | aQIV | A/H1N1 | 81.2 | 95% Confidence Interval 78.57 to 83.58 | percentage of participants |
| Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains | Comparator QIV | A/H1N1 | 76.8 | 95% Confidence Interval 74.04 to 79.42 | percentage of participants |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | aQIV | 1,027 | |
| Overall Study | STARTED | Comparator QIV | 1,017 | |
| Overall Study | Received Study Vaccine | aQIV | 1,027 | |
| Overall Study | Received Study Vaccine | Comparator QIV | 1,016 | |
| Overall Study | COMPLETED | aQIV | 982 | |
| Overall Study | COMPLETED | Comparator QIV | 989 | |
| Overall Study | NOT COMPLETED | aQIV | 45 | |
| Overall Study | NOT COMPLETED | Comparator QIV | 28 |
Source ClinicalTrials.gov
Adverse events162
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | aQIV | 81 | 1,020 | |
| other | Diarrhea | Gastrointestinal disorders | Comparator QIV | 71 | 1,008 | |
| other | Nausea | Gastrointestinal disorders | aQIV | 74 | 1,020 | |
| other | Nausea | Gastrointestinal disorders | Comparator QIV | 44 | 1,008 | |
| other | Chills | General disorders | aQIV | 67 | 1,020 | |
| other | Chills | General disorders | Comparator QIV | 55 | 1,008 | |
| other | Fatigue | General disorders | aQIV | 301 | 1,020 | |
| other | Fatigue | General disorders | Comparator QIV | 245 | 1,008 | |
| other | Induration | General disorders | aQIV | 81 | 1,020 | |
| other | Induration | General disorders | Comparator QIV | 35 | 1,008 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | aQIV | 1 | 1,027 |
| Total, all-cause mortality | Comparator QIV | 0 | 1,016 |
| Total, other adverse events | aQIV | 660 | 1,020 |
| Total, other adverse events | Comparator QIV | 519 | 1,008 |
| Total, serious adverse events | aQIV | 31 | 1,027 |
| Total, serious adverse events | Comparator QIV | 31 | 1,016 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| aQIV vs Comparator QIV: deaths from any cause | Trial comparisons |
| aQIV vs Comparator QIV: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05044195
GET https://conductscience.org/api/trials/v1/NCT05044195/results?page=2