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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1238-1970 | Other Identifier | UTN |
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Primary Objective:
Immunogenicity: To describe the immune response induced by high-dose quadrivalent influenza vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in all participants.
Safety: To describe the safety profile of all participants in each study groups.
The duration of each participant's participation was approximately 28 days (Day 0 through Day 28 [+ 7 days]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Experimental | Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0. |
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| Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Active Comparator | Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine | Biological | Pharmaceutical form: Suspension for injection in pre-filled syringe, Route of administration: IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 | 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. | Day 0 (pre-vaccination) |
| Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 | 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. | Day 28 (post-vaccination) |
| Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | GMTRs of anti-influenza antibodies were measured by 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). | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
| Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | 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 (<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer >=10 (1/dilution) at Day 0 and a >= four-fold increase in post-vaccination titer at Day 28. | Day 28 (post-vaccination) |
| Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 | Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). |
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Inclusion criteria :
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 1580004 | Taichung | 40447 | Taiwan | |||
| Investigational Site Number 1580001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36216650 | Derived | Chen JY, Hsieh SM, Hwang SJ, Liu CS, Li X, Fournier M, Yeh TY, Yin JK, Samson SI. Immunogenicity and safety of high-dose quadrivalent influenza vaccine in older adults in Taiwan: A phase III, randomized, multi-center study. Vaccine. 2022 Oct 26;40(45):6450-6454. doi: 10.1016/j.vaccine.2022.09.078. Epub 2022 Oct 7. |
| Label | URL |
|---|---|
| QHD00023 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 165 participants were vaccinated in the study.
The study was conducted at 4 active centers in Taiwan. A total of 165 participants were enrolled and randomized between 10 November 2020 to 12 January 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0. |
| FG001 | Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 14, 2019 | Aug 27, 2021 |
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The study was modified double-blind. The designated vaccine prepare(s)/administrator(s) would be unblinded given that the QIV-HD and QIV-SD vaccines had different dose volumes. Neither the participant nor the investigator nor the study staff in charge of vaccination was aware of which vaccine was administered (the syringes was masked to maintained the blinding of the participants and other members of the clinical site). The unblinded designated vaccine preparer(s)/administrator(s) was not involved in any of the blinded study assessments (eg, immunogenicity, safety).
|
| Standard-Dose Quadrivalent Influenza Vaccine | Biological | Pharmaceutical form: Suspension for injection in pre-filled syringe, Route of administration: IM |
|
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| Day 0 (pre-vaccination) |
| Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 | 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). | Day 28 (post-vaccination) |
| Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 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 causal 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 systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. | Within 30 minutes post-vaccination |
| Number of Participants With Solicited Injection Site and Systemic Reactions | 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 protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. | Within 7 days post-vaccination |
| Number of Participants With Unsolicited Adverse Events | 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 causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. | Within 28 days post-vaccination |
| Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | An 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. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. | From Day 0 up to 28 days post-vaccination |
| Taipei |
| 100 |
| Taiwan |
| Investigational Site Number 1580002 | Taipei | 112 | Taiwan |
| Investigational Site Number 1580003 | Taoyuan | 333 | Taiwan |
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. |
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. |
| BG001 | Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 | 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. | Analysis was performed on the full analysis set (FAS) that included randomized participants who received one of the study vaccine and had a post-vaccination blood sample. Participants were analyzed according to the vaccine group to which they were randomized. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 0 (pre-vaccination) |
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| Primary | Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28 | 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. | Analysis was performed on FAS. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 28 (post-vaccination) |
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| Primary | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | GMTRs of anti-influenza antibodies were measured by 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). | Analysis was performed on FAS. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
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| Primary | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | 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 (<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer >=10 (1/dilution) at Day 0 and a >= four-fold increase in post-vaccination titer at Day 28. | Analysis was performed on FAS. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 (post-vaccination) |
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| Primary | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0 | Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). | Analysis was performed on FAS. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 0 (pre-vaccination) |
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| Primary | Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28 | 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). | Analysis was performed on FAS. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 (post-vaccination) |
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| Primary | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 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 causal 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 systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. | Analysis was performed on the safety analysis set (SafAS) that included participants who had received one of the study vaccines and had any safety data available; and were analyzed according to the vaccine they actually received. | Posted | Count of Participants | Participants | Within 30 minutes post-vaccination |
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| Primary | Number of Participants With Solicited Injection Site and Systemic Reactions | 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 protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. | Analysis was performed on the SafAS. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Count of Participants | Participants | Within 7 days post-vaccination |
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| Primary | Number of Participants With Unsolicited Adverse Events | 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 causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. | Analysis was performed on the SafAS. | Posted | Count of Participants | Participants | Within 28 days post-vaccination |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | An 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. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. | Analysis was performed on the SafAS. | Posted | Count of Participants | Participants | From Day 0 up to 28 days post-vaccination |
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Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 (post-vaccination) up to 28 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 protocol and CRB and considered as related to the product administered. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on SafAS.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. | 0 | 82 | 0 | 82 | 46 | 82 |
| EG001 | Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) | Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. | 0 | 83 | 0 | 83 | 35 | 83 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Erythema | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection Site Induration | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment | Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE. |
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The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2021 | Aug 27, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| B1 |
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| B2 |
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| Units | Counts |
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| Participants |
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