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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000655-14 | EudraCT Number | ||
| U1111-1225-0952 | Other Identifier | UTN |
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Primary Objective:
To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older.
Secondary Objective:
Study duration per participant was approximately 6 months including: 1 day of screening and vaccination, an end of study visit and safety follow-up telephone call approximately at Day 28 and Day 180 after vaccination, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 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: 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 |
|---|---|---|---|---|
| Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD) | Biological | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | 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 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | 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 0 (pre-vaccination), Day 28 (post-vaccination) |
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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 Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 0560001 | Ghent | BE-9000 | Belgium | |||
| Investigational Site Number 0560002 |
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| Label | URL |
|---|---|
| QHD00011 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 1533 participants were vaccinated in the study.
The study was conducted at 17 active centers in 6 countries. A total of 1539 participants were enrolled and randomized between 28 October 2019 to 15 November 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: QIV-HD | Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. |
| FG001 | Group 2: 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 | Aug 23, 2019 | Dec 21, 2020 |
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Participants randomized in each group were stratified by age (60 to 64 years of age; 65 years of age and older).
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Modified double-blind: the participant and the Investigators remained unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member administered the appropriate vaccine but were not involved in the immunogenicity and safety evaluations.
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| High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation | Biological | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
|
| Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | 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 0 (pre-vaccination), Day 28 (post-vaccination) |
| Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | 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). | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
| Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | 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). | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
| Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | 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. | Day 28 post-vaccination |
| Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | 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. | Day 28 post-vaccination |
| Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against 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 (<) 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. | Day 28 post-vaccination |
| Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against 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 < 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. | Day 28 post-vaccination |
| Number of Participants Reporting Immediate Unsolicited 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 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. | Within 30 minutes post-vaccination |
| Number of Participants Reporting Solicited Injection Site 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 CRB and considered as related to the product administered. Solicited injection site reactions included induration, bruising, pain, erythema, and swelling. | Within 7 days post-vaccination |
| Number of Participants Reporting Solicited 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 CRB and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. | Within 7 days post-vaccination |
| Number of Participants Reporting Unsolicited 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 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. | Within 28 days post-vaccination |
| Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | 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. A SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (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 6 months post-vaccination |
| Wilrijk |
| 2610 |
| Belgium |
| Investigational Site Number 2500001 | Gières | 38610 | France |
| Investigational Site Number 2500004 | Paris | 75014 | France |
| Investigational Site Number 2500003 | Pierre-Bénite | 69495 | France |
| Investigational Site Number 2760003 | Berlin | 10629 | Germany |
| Investigational Site Number 2760005 | Berlin | 10787 | Germany |
| Investigational Site Number 2760004 | Berlin | 13347 | Germany |
| Investigational Site Number 2760001 | Essen | 45136 | Germany |
| Investigational Site Number 2760002 | Oldenburg in Holstein | 23758 | Germany |
| Investigational Site Number 3800001 | Genova | IT-16132 | Italy |
| Investigational Site Number 3800003 | Palermo | 90127 | Italy |
| Investigational Site Number 5280001 | Utrecht | 3584 CX | Netherlands |
| Investigational Site Number 6160001 | Dębica | 39-200 | Poland |
| Investigational Site Number 6160003 | Siemianowice ÅšlÄ…skie | 41-103 | Poland |
| Investigational Site Number 6160002 | Wola | 43-225 | Poland |
| Investigational Site Number 6160004 | Wroclaw | 50-452 | Poland |
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0.
| Vaccinated |
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| Full Analysis Set (FAS) | FAS included all randomized participants who received the study vaccine and had a post-vaccination blood sample. |
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| 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: QIV-HD | Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. |
| BG001 | Group 2: 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, Categorical | Count of Participants | Participants |
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| 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 Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | 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 FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 28 post-vaccination |
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| Secondary | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | 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 population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
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| Secondary | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | 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 population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
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| Secondary | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | 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). | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
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| Secondary | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | 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). | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0 (pre-vaccination), Day 28 (post-vaccination) |
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| Secondary | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | 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. | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 post-vaccination |
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| Secondary | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | 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. | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 post-vaccination |
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| Secondary | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against 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 (<) 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. | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 post-vaccination |
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| Secondary | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against 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 < 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. | Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 post-vaccination |
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| Secondary | Number of Participants Reporting Immediate Unsolicited 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 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. | Analysis was performed on safety analysis set (SafAS) which included participants who had received the study vaccine and had any safety data available. | Posted | Count of Participants | Participants | Within 30 minutes post-vaccination |
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| Secondary | Number of Participants Reporting Solicited Injection Site 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 CRB and considered as related to the product administered. Solicited injection site reactions included induration, bruising, pain, erythema, and swelling. | Analysis was performed on the SafAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Within 7 days post-vaccination |
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| Secondary | Number of Participants Reporting Solicited 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 CRB and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. | Analysis was performed on the SafAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Within 7 days post-vaccination |
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| Secondary | Number of Participants Reporting Unsolicited 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 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. | Analysis was performed on SafAS population. | Posted | Count of Participants | Participants | Within 28 days post-vaccination |
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| Secondary | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | 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. A SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (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 population. | Posted | Count of Participants | Participants | From Day 0 up to 6 months 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 throughout the study, i.e. up to 6 months post-vaccination.
Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). 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. In the AE section, solicited reactions Shivering were reported as Chills.
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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 QIV-HD | Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. | 2 | 772 | 17 | 772 | 507 | 772 |
| EG001 | Group 2 QIV-SD | Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. | 0 | 761 | 21 | 761 | 354 | 761 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA-22.1 | Systematic Assessment |
| |
| Coronary Artery Stenosis | Cardiac disorders | MedDRA-22.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA-22.1 | Systematic Assessment |
| |
| Gastric Perforation | Gastrointestinal disorders | MedDRA-22.1 | Systematic Assessment |
| |
| Intestinal Haemorrhage | Gastrointestinal disorders | MedDRA-22.1 | Systematic Assessment |
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| Intestinal Obstruction | Gastrointestinal disorders | MedDRA-22.1 | Systematic Assessment |
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| Large Intestinal Obstruction | Gastrointestinal disorders | MedDRA-22.1 | Systematic Assessment |
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| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA-22.1 | Systematic Assessment |
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| Rectal Prolapse | Gastrointestinal disorders | MedDRA-22.1 | Systematic Assessment |
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| Corona Virus Infection | Infections and infestations | MedDRA-22.1 | Systematic Assessment |
| |
| Pilonidal Cyst | Infections and infestations | MedDRA-22.1 | Systematic Assessment |
| |
| Pneumococcal Sepsis | Infections and infestations | MedDRA-22.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA-22.1 | Systematic Assessment |
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| Forearm Fracture | Injury, poisoning and procedural complications | MedDRA-22.1 | Systematic Assessment |
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| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA-22.1 | Systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA-22.1 | Systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA-22.1 | Systematic Assessment |
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| Thermal Burn | Injury, poisoning and procedural complications | MedDRA-22.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA-22.1 | Systematic Assessment |
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| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA-22.1 | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA-22.1 | Systematic Assessment |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-22.1 | Systematic Assessment |
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| Bronchial Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-22.1 | Systematic Assessment |
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| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-22.1 | Systematic Assessment |
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| Polycythaemia Vera | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-22.1 | Systematic Assessment |
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| Thyroid Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-22.1 | Systematic Assessment |
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| Cerebral Thrombosis | Nervous system disorders | MedDRA-22.1 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA-22.1 | Systematic Assessment |
| |
| Loss Of Consciousness | Nervous system disorders | MedDRA-22.1 | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA-22.1 | Systematic Assessment |
| |
| Vith Nerve Paralysis | Nervous system disorders | MedDRA-22.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA-22.1 | Systematic Assessment |
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| Urinary Incontinence | Renal and urinary disorders | MedDRA-22.1 | Systematic Assessment |
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| Prostatitis | Reproductive system and breast disorders | MedDRA-22.1 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA-22.1 | Systematic Assessment |
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| Intermittent Claudication | Vascular disorders | MedDRA-22.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA-22.1 | Systematic Assessment | Chills/Shivering events that occurred after 7 days post-vaccination were considered as unsolicited AE. |
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| Injection Site Erythema | General disorders | MedDRA-22.1 | Systematic Assessment |
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| Injection Site Induration | General disorders | MedDRA-22.1 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA-22.1 | Systematic Assessment | Pain events that occurred after 7 days post-vaccination were considered as unsolicited AE. |
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| Injection Site Swelling | General disorders | MedDRA-22.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA-22.1 | Systematic Assessment | Malaise events that occurred after 7 days post-vaccination were considered as unsolicited AE. |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA-22.1 | Systematic Assessment | Myalgia events that occurred after 7 days post-vaccination were considered as unsolicited AE. |
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| Headache | Nervous system disorders | MedDRA-22.1 | 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 | 1# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2020 | Dec 21, 2020 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D006388 | Hemagglutinins |
| D009439 | Neuraminidase |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D000373 | Agglutinins |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D003029 | Coagulants |
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| >=65 years |
|
| 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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| A/H3N2: Day 28: 60-64 years |
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| B1: Day 28: 60-64 years |
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| B2: Day 28: 60-64 years |
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| A/H1N1: Day 28: >= 65 years |
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| A/H3N2: Day 28: >=65 years |
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| B1: Day 28: >=65 years |
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| B2: Day 28: >=65 years |
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A/H3N2: 60-64 years |
| GMT ratio |
| 1.70 |
| 2-Sided |
| 95 |
| 1.38 |
| 2.08 |
| Superiority |
Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons. |
| B1: 60-64 years | GMT ratio | 1.51 | 2-Sided | 95 | 1.30 | 1.74 | Superiority | Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons. |
| B2: 60-64 years | GMT ratio | 1.77 | 2-Sided | 95 | 1.53 | 2.04 | Superiority | Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons. |
| A/H1N1: >=65 years | GMT ratio | 1.76 | 2-Sided | 95 | 1.44 | 2.15 | Superiority | Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons. |
| A/H3N2: >=65 years | GMT ratio | 2.15 | 2-Sided | 95 | 1.74 | 2.65 | Superiority | Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons. |
| B1: >=65 years | GMT ratio | 1.55 | 2-Sided | 95 | 1.34 | 1.79 | Superiority | Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons. |
| B2: >=65 years | GMT ratio | 1.76 | 2-Sided | 95 | 1.52 | 2.03 | Superiority | Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons. |
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