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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1253-2122 | Registry Identifier | ICTRP |
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The duration of each participant's participation was approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4) | Experimental | Participants received a single intramuscular (IM) injection of 0.5 milliliters (mL) RIV4 on Day 1. |
|
| Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4) | Active Comparator | Participants received a single IM injection of 0.5 mL IIV4 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Recombinant Influenza Vaccine (RIV4) | Biological | Solution for intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS) | GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution. | Day 1 (pre-vaccination) |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS) | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution. | Day 1 (pre-vaccination) |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPAS | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution. | Day 29 (post-vaccination) |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FAS | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution. | Day 29 (post-vaccination) |
| Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPAS | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1). | Day 1 (pre-vaccination) and Day 29 (post-vaccination) |
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Inclusion Criteria:
Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR Was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study intervention administration until at least 4 weeks after study intervention administration.
A female participant of childbearing potential must had a negative highly sensitive pregnancy test (urine) before the first dose of study intervention.
Exclusion Criteria:
Participants were excluded from the study if any of the following criteria applied:
The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :4100003 | Ansan-si | Gyeonggi-do | 15355 | South Korea | ||
| Investigational Site Number :4100001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40752250 | Derived | Choi WS, Lee J, Ottaviano C, Samson S, Peng L, Shin S, Choe S, Kim WJ. Immunogenicity and safety of quadrivalent recombinant influenza vaccine in Korean adults: Phase III, randomized study. Vaccine. 2025 Aug 30;62:127521. doi: 10.1016/j.vaccine.2025.127521. Epub 2025 Aug 5. |
| Label | URL |
|---|---|
| VAP00016 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 301 participants were enrolled and randomized in the study.
The study was conducted at 3 active sites in South Korea from 07 December 2021 to 01 September 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4) | Participants received a single intramuscular (IM) injection of 0.5 milliliters (mL) RIV4 on Day 1. |
| FG001 | Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4) |
| 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 | Jan 20, 2022 | Aug 30, 2023 |
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In each age group (18-49 and >= 50 years of age), participants were randomized in a 1:1 ratio to each of the vaccines.
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Modified double-blind: A designated unblinded administrator administered the appropriate vaccine but was not involved in the immunogenicity and safety assessments.
| Quadrivalent inactivated influenza vaccine (IIV4) | Biological | Suspension for intramuscular injection |
|
|
| Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FAS | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1). | Day 1 (pre-vaccination) and Day 29 (post-vaccination) |
| Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPAS | Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination 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 29. | Day 29 (post-vaccination) |
| Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FAS | Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination 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 29. | Day 29 (post-vaccination) |
| Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS | Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure. | Day 1 (pre-vaccination) and Day 29 (post-vaccination) |
| Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS | Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure. | Day 1 (pre-vaccination) and Day 29 (post-vaccination) |
| Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS | Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure. | Day 1 (pre-vaccination) and Day 29 (post-vaccination) |
| Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS | Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure. | Day 1 (pre-vaccination) and Day 29 (post-vaccination) |
| Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence 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 form (CRF) 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 CRF. | Within 30 minutes 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 CRF and considered as related to the study intervention administered. Solicited systemic reactions included fever, headache, malaise, myalgia, shivering, fatigue, nausea, and arthralgia. | Within 7 days 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 CRF and considered as related to the study intervention administered. Solicited injection site reactions included pain, erythema, swelling, induration, bruising and tenderness. | Within 7 days post-vaccination |
| Number of Participants Reporting Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence 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 CRF in terms of diagnosis and/or onset window post-vaccination. | From Day 1 up to 28 days post-vaccination (i.e., up to Day 29) |
| Number of Participants Reporting Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | 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. An AESIs were defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. | From Day 1 up to 6 months post-vaccination (i.e., up to Day 181) |
| Seoul |
| Seoul-teukbyeolsi |
| 152-703 |
| South Korea |
| Investigational Site Number :4100002 | Seoul | 07441 | South Korea |
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
| Safety Analysis Set | Participants who received a dose of the study vaccine and were analyzed according to the vaccine they actually received. |
|
| 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: Quadrivalent Recombinant Influenza Vaccine (RIV4) | Participants received a single IM injection of 0.5 mL RIV4 on Day 1. |
| BG001 | Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4) | Participants received a single IM injection of 0.5 mL IIV4 on Day 1. |
| 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 and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | 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 1- Per Protocol Analysis Set (PPAS) | GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution. | Analysis was performed on PPAS population that included all randomized participants who received a dose of the study vaccine and had a post-vaccination blood sample. Participants with protocol deviations were excluded from the PPAS. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 1 (pre-vaccination) |
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| Primary | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS) | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution. | Analysis was performed on FAS population that included all randomized participants who received a dose of the study vaccine and had a post-vaccination blood sample. Participants were analyzed according to the intervention to which they were randomized. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 1 (pre-vaccination) |
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| Primary | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPAS | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution. | Analysis was performed on PPAS population. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 29 (post-vaccination) |
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| Primary | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FAS | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution. | Analysis was performed on FAS population. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 29 (post-vaccination) |
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| Primary | Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPAS | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1). | Analysis was performed on PPAS population. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 1 (pre-vaccination) and Day 29 (post-vaccination) |
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| Primary | Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FAS | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1). | Analysis was performed on FAS population. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 1 (pre-vaccination) and Day 29 (post-vaccination) |
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| Primary | Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPAS | Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination 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 29. | Analysis was performed on PPAS population. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 (post-vaccination) |
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| Primary | Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FAS | Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination 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 29. | 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 29 (post-vaccination) |
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| Primary | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS | Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure. | Analysis was performed on PPAS population. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 (pre-vaccination) and Day 29 (post-vaccination) |
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| Primary | Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS | Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this 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 1 (pre-vaccination) and Day 29 (post-vaccination) |
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| Primary | Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS | Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure. | Analysis was performed on PPAS population. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 (pre-vaccination) and Day 29 (post-vaccination) |
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| Primary | Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS | Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this 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 1 (pre-vaccination) and Day 29 (post-vaccination) |
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| Primary | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence 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 form (CRF) 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 CRF. | Analysis was performed on safety analysis set that included participants who had received a dose of the study vaccine 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 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 CRF and considered as related to the study intervention administered. Solicited systemic reactions included fever, headache, malaise, myalgia, shivering, fatigue, nausea, and arthralgia. | Analysis was performed on safety analysis set. | Posted | Count of Participants | Participants | Within 7 days post-vaccination |
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| Primary | 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 CRF and considered as related to the study intervention administered. Solicited injection site reactions included pain, erythema, swelling, induration, bruising and tenderness. | Analysis was performed on safety analysis set. | Posted | Count of Participants | Participants | Within 7 days post-vaccination |
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| Primary | Number of Participants Reporting Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence 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 CRF in terms of diagnosis and/or onset window post-vaccination. | Analysis was performed on safety analysis set. | Posted | Count of Participants | Participants | From Day 1 up to 28 days post-vaccination (i.e., up to Day 29) |
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| Primary | Number of Participants Reporting Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | 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. An AESIs were defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. | Analysis was performed on safety analysis set. | Posted | Count of Participants | Participants | From Day 1 up to 6 months post-vaccination (i.e., up to Day 181) |
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Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF 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 CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was 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: Quadrivalent Recombinant Influenza Vaccine (RIV4) | Participants received a single IM injection of 0.5 mL RIV4 on Day 1. | 0 | 149 | 0 | 149 | 96 | 149 |
| EG001 | Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4) | Participants received a single IM injection of 0.5 mL IIV4 on Day 1. | 0 | 151 | 0 | 151 | 100 | 151 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA 25.1 | Systematic Assessment | Pain events that occurred after 7 days post-vaccination were considered as unsolicited AE. |
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| Malaise | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | 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 | Feb 28, 2023 | Aug 30, 2023 | 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 |
| C510903 | fluarix |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| B/Victoria |
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| B/Yamagata |
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