Trial · NCT04498832
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 Japanese Adults 60 Years of Age and Older
NCT04498832, Phase 3, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2022-02-08
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 Japanese Adults 60 Years of Age and Older. Trials, record NCT04498832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04498832
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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 Japanese Adults 60 Years of Age and Older
- NCT number
- NCT04498832
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,100 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Influenza Immunization, Healthy Volunteers
- Interventions
- High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD), Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)
- First posted
- 2020-08-05
- Last updated
- 2025-09-23
- Results first posted
- 2022-02-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | 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-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution. |
| Primary | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | Day 28 (post-vaccination) | Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. |
| Secondary | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | Day 0 (pre-vaccination) and Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution. |
| Secondary | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). |
| Secondary | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | Day 28 (post-vaccination) | Anti-influenza antibodies were measured by HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer \<10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. |
| Secondary | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | Day 0 (pre-vaccination), Day 28 (post-vaccination) | Anti-influenza antibodies were measured using HAI assay method for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Percentage of participants with HAI titers \>=40 (1/dilution) 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 necessarily have a 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 that occurred during that time were recorded as immediate unsolicited AEs in the CRB. |
| Secondary | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Within 7 days post-vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included injection site pain, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. |
| Secondary | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Within 28 days 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 necessarily have a 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. |
| Secondary | Number of Participants Reporting Serious Adverse Events (SAEs) | From Day 0 up to Day 28 post-vaccination | A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. |
Source ClinicalTrials.gov
Outcomes10
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 Vaccine Antibodies at Day 28 | Day 28 (post-vaccination) | Analysis was performed on full analysis set (FAS) population which included all randomized participants who received at least one dose of the study vaccine and had a post-vaccination blood sample HAI result for at least one strain. Here, 'Number analyzed' = participants with available data for each specified category. | titers | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | 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 | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | Day 0 (pre-vaccination) and 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 Ratio (GMTR) of Influenza Vaccine Antibodies | 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 Achieving Seroconversion Against Influenza Virus 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 With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | 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. | 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) population which included participants who had received the study vaccine and had any safety data available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Within 7 days post-vaccination | Analysis was performed on the SafAS population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Within 28 days post-vaccination | Analysis was performed on SafAS population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Serious Adverse Events (SAEs) | From Day 0 up to Day 28 post-vaccination | Analysis was performed on the SafAS population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group114
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 Vaccine Antibodies at Day 28 | QIV-HD | A/H1N1 | 309.0 | 95% Confidence Interval 282.1 to 338.4 | titers |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | QIV-SD | A/H1N1 | 110.0 | 95% Confidence Interval 100.0 to 121.1 | titers |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | QIV-HD | A/H3N2-like | 540.0 | 95% Confidence Interval 504.4 to 578.0 | titers |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | QIV-SD | A/H3N2-like | 239.9 | 95% Confidence Interval 222.0 to 259.1 | titers |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | QIV-HD | B/Victoria-like | 354.8 | 95% Confidence Interval 333.0 to 378.0 | titers |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | QIV-SD | B/Victoria-like | 139.2 | 95% Confidence Interval 129.4 to 149.8 | titers |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | QIV-HD | B/Yamagata | 795.8 | 95% Confidence Interval 750.3 to 844.1 | titers |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | QIV-SD | B/Yamagata | 254.7 | 95% Confidence Interval 237.7 to 273.0 | titers |
| Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | QIV-HD | A/H1N1 | 77.6 | 95% Confidence Interval 75.0 to 80.1 | percentage of participants |
| Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | QIV-SD | A/H1N1 | 47.9 | 95% Confidence Interval 44.9 to 51.0 | percentage of participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QIV-HD | 1,049 | |
| Overall Study | STARTED | QIV-SD | 1,051 | |
| Overall Study | COMPLETED | QIV-HD | 1,048 | |
| Overall Study | COMPLETED | QIV-SD | 1,047 | |
| Overall Study | NOT COMPLETED | QIV-HD | 1 | |
| Overall Study | NOT COMPLETED | QIV-SD | 4 |
Source ClinicalTrials.gov
Adverse events28
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 | Injection Site Erythema | General disorders | QIV-HD | 86 | 1,049 | 86 |
| other | Injection Site Erythema | General disorders | QIV-SD | 328 | 1,051 | 328 |
| other | Injection Site Induration | General disorders | QIV-HD | 52 | 1,049 | 52 |
| other | Injection Site Induration | General disorders | QIV-SD | 107 | 1,051 | 107 |
| other | Injection Site Pain | General disorders | QIV-HD | 503 | 1,049 | 504 |
| other | Injection Site Pain | General disorders | QIV-SD | 334 | 1,051 | 334 |
| other | Injection Site Swelling | General disorders | QIV-HD | 82 | 1,049 | 82 |
| other | Injection Site Swelling | General disorders | QIV-SD | 185 | 1,051 | 185 |
| other | Malaise | General disorders | QIV-HD | 102 | 1,049 | 103 |
| other | Malaise | General disorders | QIV-SD | 59 | 1,051 | 59 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QIV-HD | 0 | 1,049 |
| Total, all-cause mortality | QIV-SD | 0 | 1,051 |
| Total, other adverse events | QIV-HD | 614 | 1,049 |
| Total, other adverse events | QIV-SD | 569 | 1,051 |
| Total, serious adverse events | QIV-HD | 2 | 1,049 |
| Total, serious adverse events | QIV-SD | 5 | 1,051 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36906404 | BACKGROUND |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| QIV-HD vs QIV-SD: Number of Participants Reporting Unsolicited Adverse Events (AEs) | Trial comparisons |
| QIV-HD vs QIV-SD: Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Trial comparisons |
| QIV-HD vs QIV-SD: Number of Participants Reporting Serious Adverse Events (SAEs) | Trial comparisons |
| QIV-HD vs QIV-SD: deaths from any cause | Trial comparisons |
| QIV-HD vs 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/NCT04498832
GET https://conductscience.org/api/trials/v1/NCT04498832/results?page=2