Trial · NCT04024228
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older
NCT04024228, Phase 3, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2021-01-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older. Trials, record NCT04024228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04024228
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older
- NCT number
- NCT04024228
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,539 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Influenza Immunization, Healthy Volunteers
- Interventions
Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD), High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation
- First posted
- 2019-07-18
- Last updated
- 2025-09-12
- Other registries' IDs
- eudract:2019-000655-14
- Results first posted
- 2021-01-19
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Day 28 post-vaccination | GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution. |
| Secondary | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution. |
| Secondary | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution. |
| Secondary | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). |
| Secondary | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). |
| Secondary | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | Day 28 post-vaccination | Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (all age group participants) with neutralizing antibody titers \>=40 (1/dilution) is reported in the outcome measure. |
| Secondary | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | Day 28 post-vaccination | Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (aged 60-64 Years and \>=65 Years) with neutralizing antibody titers \>=40 (1/dilution) is reported in the outcome measure. |
| Secondary | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | Day 28 post-vaccination | Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 1:10 (1/dilution) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (all age group participants) achieving seroconversion is reported in the outcome measure. |
| Secondary | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | Day 28 post-vaccination | Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 (1/dilution) and a post-vaccination titer \>= 1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (aged 60-64 Years and \>=65 Years) achieving seroconversion is reported in the outcome measure. |
| Secondary | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post-vaccination | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. |
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 | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Day 28 post-vaccination | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | titers | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | Day 0 (pre-vaccination), Day 28 (post-vaccination) | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | titers | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | Day 0 (pre-vaccination), Day 28 (post-vaccination) | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | titers | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | Day 0 (pre-vaccination), Day 28 (post-vaccination) | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | Day 0 (pre-vaccination), Day 28 (post-vaccination) | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | Day 28 post-vaccination | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | Day 28 post-vaccination | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | Day 28 post-vaccination | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | Day 28 post-vaccination | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post-vaccination | Analysis was performed on safety analysis set (SafAS) which included participants who had received the study vaccine and had any safety data available. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Group 1: QIV-HD | A/H1N1: Day 28: 60-64 years | 471 | 95% Confidence Interval 416 to 533 | titers |
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Group 2: QIV-SD | A/H1N1: Day 28: 60-64 years | 248 | 95% Confidence Interval 217 to 283 | titers |
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Group 1: QIV-HD | A/H3N2: Day 28: 60-64 years | 303 | 95% Confidence Interval 262 to 350 | titers |
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Group 2: QIV-SD | A/H3N2: Day 28: 60-64 years | 178 | 95% Confidence Interval 154 to 206 | titers |
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Group 1: QIV-HD | B1: Day 28: 60-64 years | 497 | 95% Confidence Interval 450 to 548 | titers |
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Group 2: QIV-SD | B1: Day 28: 60-64 years | 330 | 95% Confidence Interval 297 to 367 | titers |
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Group 1: QIV-HD | B2: Day 28: 60-64 years | 766 | 95% Confidence Interval 690 to 849 | titers |
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Group 2: QIV-SD | B2: Day 28: 60-64 years | 433 | 95% Confidence Interval 391 to 480 | titers |
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Group 1: QIV-HD | A/H1N1: Day 28: >= 65 years | 286 | 95% Confidence Interval 250 to 326 | titers |
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Group 2: QIV-SD | A/H1N1: Day 28: >= 65 years | 162 | 95% Confidence Interval 139 to 190 | titers |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: QIV-HD | 774 | |
| Overall Study | STARTED | Group 2: QIV-SD | 765 | |
| Overall Study | Vaccinated | Group 1: QIV-HD | 772 | |
| Overall Study | Vaccinated | Group 2: QIV-SD | 761 | |
| Overall Study | Full Analysis Set (FAS) | Group 1: QIV-HD | 769 | |
| Overall Study | Full Analysis Set (FAS) | Group 2: QIV-SD | 758 | |
| Overall Study | COMPLETED | Group 1: QIV-HD | 770 | |
| Overall Study | COMPLETED | Group 2: QIV-SD | 759 | |
| Overall Study | NOT COMPLETED | Group 1: QIV-HD | 4 | |
| Overall Study | NOT COMPLETED | Group 2: QIV-SD | 6 |
Source ClinicalTrials.gov
Adverse events88
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 | Chills | General disorders | Group 1 QIV-HD | 128 | 772 | 130 |
| other | Chills | General disorders | Group 2 QIV-SD | 57 | 761 | 58 |
| other | Injection Site Erythema | General disorders | Group 1 QIV-HD | 157 | 772 | 158 |
| other | Injection Site Erythema | General disorders | Group 2 QIV-SD | 85 | 761 | 85 |
| other | Injection Site Induration | General disorders | Group 1 QIV-HD | 132 | 772 | 133 |
| other | Injection Site Induration | General disorders | Group 2 QIV-SD | 64 | 761 | 64 |
| other | Injection Site Pain | General disorders | Group 1 QIV-HD | 350 | 772 | 350 |
| other | Injection Site Pain | General disorders | Group 2 QIV-SD | 161 | 761 | 161 |
| other | Injection Site Swelling | General disorders | Group 1 QIV-HD | 140 | 772 | 140 |
| other | Injection Site Swelling | General disorders | Group 2 QIV-SD | 62 | 761 | 62 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 QIV-HD | 2 | 772 |
| Total, all-cause mortality | Group 2 QIV-SD | 0 | 761 |
| Total, other adverse events | Group 1 QIV-HD | 507 | 772 |
| Total, other adverse events | Group 2 QIV-SD | 354 | 761 |
| Total, serious adverse events | Group 1 QIV-HD | 17 | 772 |
| Total, serious adverse events | Group 2 QIV-SD | 21 | 761 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: QIV-HD vs Group 2: QIV-SD: Number of Participants Reporting Unsolicited Adverse Events (AEs) | Trial comparisons |
| Group 1: QIV-HD vs Group 2: QIV-SD: Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Trial comparisons |
| Group 1 QIV-HD vs Group 2 QIV-SD: deaths from any cause | Trial comparisons |
| Group 1 QIV-HD vs Group 2 QIV-SD: 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/NCT04024228
GET https://conductscience.org/api/trials/v1/NCT04024228/results?page=2