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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1183-5556 | Other Identifier | World Health Organization Universal Trial Number |
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This randomized, modified double-blind, active-controlled, multi-center trial assessed the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in adults.
This randomized, modified double-blind, active-controlled, multi-center trial was conducted in healthy adults (greater than and equal to [>=] 65 years) to assess the safety and immunogenicity (geometric mean titers and seroconversion for the 4 virus strains at 28 days post vaccination) of the QIV-HD compared to one of the TIV-HDs containing either the B strain from the primary lineage (TIV-HD1; licensed vaccine [Fluzone® High-Dose] for the 2017-2018 Northern Hemisphere [NH] influenza season) or the B strain from the alternate lineage (TIV-HD2, investigational TIV-HD containing an alternate B strain).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QIV-HD | Experimental | Participants randomized to receive a single injection of 0.7 mL QIV-HD by intramuscular (IM) route at Day 0. |
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| TIV-HD1 (Licensed TIV-HD1) | Active Comparator | Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0. |
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| TIV-HD2 (Investigational TIV-HD2) | Active Comparator | Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QIV-HD | Biological | 0.7 mL-dose was administered intramuscularly (IM) into the upper arm area. |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain. | Day 28 post-vaccination |
| Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (>=) 40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain. | Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). For each B strain, the immunogenicity of QIV-HD was compared to that of TIV-HD group which contains the corresponding B strain. TIV-HD1 did not contain B2 strain; TIV-HD2 did not contain B1 strain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi Pasteur Investigational Site 037 | Anaheim | California | 92801 | United States | ||
| Sanofi Pasteur Investigational Site 029 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31431411 | Derived | Chang LJ, Meng Y, Janosczyk H, Landolfi V, Talbot HK; QHD00013 Study Group. Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults >/=65 years of age: A phase 3 randomized clinical trial. Vaccine. 2019 Sep 16;37(39):5825-5834. doi: 10.1016/j.vaccine.2019.08.016. Epub 2019 Aug 17. |
| Label | URL |
|---|---|
| Related info | 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 2670 participants were randomized in the study.
Study participants were screened in 35 centers in the Unites States (US) from 08 September 2017 to 15 September 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Participants randomized to receive a single injection of 0.7 mL high dose quadrivalent influenza vaccine (QIV-HD) by intramuscular (IM) route at Day 0. |
| FG001 | High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1) |
| 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 | Jul 20, 2017 | Nov 28, 2019 |
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QHD00013 was a phase III, randomized, modified double-blind, active-controlled, multi-center trial.
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QHD00013 was a modified double-blind trial with an unblinded administrator used at each trial site. The administrator was not involved in any of the blinded study assessments (e.g., safety).
| Licensed TIV-HD1 | Biological | 0.5 mL-dose was administered IM into the upper arm area. |
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| Investigational TIV-HD2 | Biological | 0.5 mL-dose was administered IM into the upper arm area. |
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| Day 28 post-vaccination |
| GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | GMTs of anti-influenza antibodies using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Geometric Mean Titers Ratios (GMTRs) were calculated as the ratio of GMTs post vaccination and pre-vaccination. | Day 0 (pre-vaccination) and Day 28 post-vaccination |
| Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Seroconversion was defined as either a HAI titer <10 (1/dilution) at Day 0 and post-injection titer >=40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28. | Day 28 post-vaccination |
| Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). Seroprotection was defined as a HAI titer >=40 (1/dilution) at Day 0 and Day 28. | Day 0 (pre-vaccination) and Day 28 post-vaccination |
| Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | GMTs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). | Day 0 (pre-vaccination) and Day 28 post-vaccination |
| GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | GMTRs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination. | Day 0 (pre-vaccination) and Day 28 post-vaccination |
| Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Neutralizing antibody was defined as titers >=20 (1/dilution), >=40 (1/dilution), >=80 (1/dilution) at Day 0 and Day 28. | Day 0, Day 28 |
| Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / baseline computed value. | Day 28 |
| Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Detectable neutralization antibody titer >= 1:10 (1/dilution) at Day 0 and Day 28. | Day 0, Day 28 |
| Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Solicited injection site: Pain, Erythema, Swelling, Induration, and Bruising. Grade 3 reactions: Pain - interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention; Erythema, Swelling, Induration, and Bruising: >100 millimeters (mm). Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 reactions: Fever: >=39°C; Headache, Malaise, Myalgia, and Shivering: interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. | Within 7 days after vaccination |
| Number of Participants With Immediate Adverse Event (AEs) | Participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurring during that time was recorded as immediate unsolicited systemic AEs (AEs that were related to the investigational product) in the case report book (CRB). Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/ or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. | Within 30 minutes after vaccination |
| Number of Participant With Unsolicited Adverse Event (AE) | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. | Within 28 days after vaccination |
| Number of Participant With Serious Adverse Event | An serious adverse event was any untoward medical occurrence that at any dose results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect, or was an important medical event. | Up to 6 months after vaccination |
| Redding |
| California |
| 96001 |
| United States |
| Sanofi Pasteur Investigational Site 003 | San Diego | California | 92117 | United States |
| Sanofi Pasteur Investigational Site 016 | Colorado Springs | Colorado | 80920 | United States |
| Sanofi Pasteur Investigational Site 035 | Milford | Connecticut | 06460 | United States |
| Sanofi Pasteur Investigational Site 031 | Hollywood | Florida | 33024 | United States |
| Sanofi Pasteur Investigational Site 009 | Jacksonville | Florida | 32205 | United States |
| Sanofi Pasteur Investigational Site 017 | Jacksonville | Florida | 32216 | United States |
| Sanofi Pasteur Investigational Site 030 | Stockbridge | Georgia | 30281 | United States |
| Sanofi Pasteur Investigational Site 010 | Boise | Idaho | 83712 | United States |
| Sanofi Pasteur Investigational Site 034 | Meridian | Idaho | 83642 | United States |
| Sanofi Pasteur Investigational Site 021 | Council Bluffs | Iowa | 51501 | United States |
| Sanofi Pasteur Investigational Site 023 | Wichita | Kansas | 67205 | United States |
| Sanofi Pasteur Investigational Site 028 | Wichita | Kansas | 67207 | United States |
| Sanofi Pasteur Investigational Site 012 | Bardstown | Kentucky | 40004 | United States |
| Sanofi Pasteur Investigational Site 018 | Metairie | Louisiana | 70427 | United States |
| Sanofi Pasteur Investigational Site 026 | Biloxi | Mississippi | 39531 | United States |
| Sanofi Pasteur Investigational Site 014 | St Louis | Missouri | 63104 | United States |
| Sanofi Pasteur Investigational Site 011 | Omaha | Nebraska | 68134 | United States |
| Sanofi Pasteur Investigational Site 024 | Las Vegas | Nevada | 89104 | United States |
| Sanofi Pasteur Investigational Site 008 | Rochester | New York | 14609 | United States |
| Sanofi Pasteur Investigational Site 005 | Wilmington | North Carolina | 28401 | United States |
| Sanofi Pasteur Investigational Site 036 | Winston-Salem | North Carolina | 27045 | United States |
| Sanofi Pasteur Investigational Site 004 | Cleveland | Ohio | 44122 | United States |
| Sanofi Pasteur Investigational Site 015 | Oklahoma City | Oklahoma | 73112 | United States |
| Sanofi Pasteur Investigational Site 013 | Warwick | Rhode Island | 02886 | United States |
| Sanofi Pasteur Investigational Site 033 | Mt. Pleasant | South Carolina | 29464 | United States |
| Sanofi Pasteur Investigational Site 001 | Nashville | Tennessee | 37212 | United States |
| Sanofi Pasteur Investigational Site 002 | Dallas | Texas | 75234 | United States |
| Sanofi Pasteur Investigational Site 025 | Tomball | Texas | 77375 | United States |
| Sanofi Pasteur Investigational Site 027 | Salt Lake City | Utah | 84109 | United States |
| Sanofi Pasteur Investigational Site 006 | Salt Lake City | Utah | 84121 | United States |
| Sanofi Pasteur Investigational Site 019 | Salt Lake City | Utah | 84123 | United States |
| Sanofi Pasteur Investigational Site 020 | South Jordan | Utah | 84095 | United States |
| Sanofi Pasteur Investigational Site 022 | West Jordan | Utah | 83642 | United States |
| Sanofi Pasteur Investigational Site 038 | Norfolk | Virginia | 23507 | United States |
Participants randomized to receive a single injection of 0.5 mL licensed high dose trivalent influenza vaccine (TIV-HD1) by IM route at Day 0. |
| FG002 | High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Participants randomized to receive a single injection of 0.5 mL investigational high dose trivalent influenza vaccine with alternate B strain (TIV-HD2) by IM route at Day 0. |
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| NOT COMPLETED |
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Analysis was performed on all randomized participants for whom a vaccine group was allocated.
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| ID | Title | Description |
|---|---|---|
| BG000 | High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0. |
| BG001 | High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1) | Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0. |
| BG002 | High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain. | Per-protocol analysis set (PPAS): all randomized participants who received at least 1 dose of trial vaccine & had a post-vaccination blood sample HAI result for at least 1 strain, with no relevant protocol deviations. Here, 'number analyzed' = participants with available data for each category. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | Day 28 post-vaccination |
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| Primary | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (>=) 40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain. | Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 post-vaccination |
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| Secondary | GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). For each B strain, the immunogenicity of QIV-HD was compared to that of TIV-HD group which contains the corresponding B strain. TIV-HD1 did not contain B2 strain; TIV-HD2 did not contain B1 strain. | Analysis was performed on full analysis set (FAS) that consisted who received at least 1 dose of a trial vaccine and had a post-vaccination blood sample HAI result for at least 1 strain. Participants were analyzed according to the vaccine group to which they were randomized. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | Day 28 post-vaccination |
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| Secondary | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | GMTs of anti-influenza antibodies using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Geometric Mean Titers Ratios (GMTRs) were calculated as the ratio of GMTs post vaccination and pre-vaccination. | Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category. | Posted | Number | 95% Confidence Interval | ratio | Day 0 (pre-vaccination) and Day 28 post-vaccination |
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| Secondary | Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Seroconversion was defined as either a HAI titer <10 (1/dilution) at Day 0 and post-injection titer >=40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28. | Analysis was performed on FAS. Here, 'number analyzed' = participants with available data for each category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 post-vaccination |
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| Secondary | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). Seroprotection was defined as a HAI titer >=40 (1/dilution) at Day 0 and Day 28. | Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 0 (pre-vaccination) and Day 28 post-vaccination |
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| Secondary | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | GMTs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). | Expanded immunogenicity subset:participants who received at least 1 dose of trial vaccine& had post-vaccination blood sample HAI result for at least 1 strain& were randomized into expanded immunogenicity subset with at least 1 post-vaccination SN assay result for at least 1 strain.'Number analyzed'=participants with available data for each category | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | Day 0 (pre-vaccination) and Day 28 post-vaccination |
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| Secondary | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | GMTRs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination. | Analysis was performed on expanded immunogenicity subset. Here, 'number analyzed' = participants with available data for each category. | Posted | Number | 95% Confidence Interval | ratio | Day 0 (pre-vaccination) and Day 28 post-vaccination |
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| Secondary | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Neutralizing antibody was defined as titers >=20 (1/dilution), >=40 (1/dilution), >=80 (1/dilution) at Day 0 and Day 28. | Analysis was performed on expanded immunogenicity subset. | Posted | Count of Participants | Participants | Day 0, Day 28 |
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| Secondary | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / baseline computed value. | Analysis was performed on expanded immunogenicity subset. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | Posted | Count of Participants | Participants | Day 28 |
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| Secondary | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Detectable neutralization antibody titer >= 1:10 (1/dilution) at Day 0 and Day 28. | Analysis was performed on expanded immunogenicity subset. Here, 'number analyzed' = participants with available data for each category. | Posted | Count of Participants | Participants | Day 0, Day 28 |
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| Secondary | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Solicited injection site: Pain, Erythema, Swelling, Induration, and Bruising. Grade 3 reactions: Pain - interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention; Erythema, Swelling, Induration, and Bruising: >100 millimeters (mm). Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 reactions: Fever: >=39°C; Headache, Malaise, Myalgia, and Shivering: interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. | Analysis was performed on safety analysis set that included all participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Count of Participants | Participants | Within 7 days after vaccination |
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| Secondary | Number of Participants With Immediate Adverse Event (AEs) | Participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurring during that time was recorded as immediate unsolicited systemic AEs (AEs that were related to the investigational product) in the case report book (CRB). Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/ or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. | Analysis was performed on safety analysis set. | Posted | Count of Participants | Participants | Within 30 minutes after vaccination |
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| Secondary | Number of Participant With Unsolicited Adverse Event (AE) | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. | Analysis was performed on safety analysis set. | Posted | Count of Participants | Participants | Within 28 days after vaccination |
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| Secondary | Number of Participant With Serious Adverse Event | An serious adverse event was any untoward medical occurrence that at any dose results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect, or was an important medical event. | Analysis was performed on safety analysis set. | Posted | Count of Participants | Participants | Up to 6 months after vaccination |
|
Adverse events were collected from Day 0 (post-vaccination) up to 28 days after last vaccination. Solicited Reaction (SR) data were collected up to Day 7 after each vaccination. Serious adverse event data were collected throughout the study (up to 180 days after last vaccination).
Analysis was performed on safety analysis set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) 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 eCRF in terms of symptom and/or onset post-vaccination.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Participants randomized to receive a single injection of the high dose QIV-HD by IM route at Day 0. | 3 | 1,777 | 80 | 1,777 | 935 | 1,777 |
| EG001 | High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Participants randomized to receive a single injection of the licensed high dose TIV-HD1 by IM route at Day 0. | 2 | 443 | 29 | 443 | 234 | 443 |
| EG002 | High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Participants randomized to receive a single injection of the investigational TIV-HD2 by IM route at Day 0. | 0 | 450 | 19 | 450 | 206 | 450 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic Anaemia | Blood and lymphatic system disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Stress Cardiomyopathy | Cardiac disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Diverticulum Intestinal Haemorrhagic | Gastrointestinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Gastrointestinal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Vascular Stent Thrombosis | General disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Parainfluenzae Viral Laryngotracheobronchitis | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Streptococcal Infection | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA-20.1 | Systematic Assessment |
| |
| Anaesthetic Complication | Injury, poisoning and procedural complications | MedDRA-20.1 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA-20.1 | Systematic Assessment |
| |
| Bone Contusion | Injury, poisoning and procedural complications | MedDRA-20.1 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA-20.1 | Systematic Assessment |
| |
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA-20.1 | Systematic Assessment |
| |
| Postpericardiotomy Syndrome | Injury, poisoning and procedural complications | MedDRA-20.1 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA-20.1 | Systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA-20.1 | Systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA-20.1 | Systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA-20.1 | Systematic Assessment |
| |
| Troponin Increased | Investigations | MedDRA-20.1 | Systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-20.1 | Systematic Assessment |
| |
| Brain Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-20.1 | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-20.1 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-20.1 | Systematic Assessment |
| |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-20.1 | Systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-20.1 | Systematic Assessment |
| |
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-20.1 | Systematic Assessment |
| |
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-20.1 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-20.1 | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA-20.1 | Systematic Assessment |
| |
| Carotid Artery Occlusion | Nervous system disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Carotid Artery Stenosis | Nervous system disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Cerebrospinal Fluid Leakage | Nervous system disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Facial Paralysis | Nervous system disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Ischaemic Cerebral Infarction | Nervous system disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Small Fibre Neuropathy | Nervous system disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Aortic Stenosis | Vascular disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Peripheral Vascular Disorder | Vascular disorders | MedDRA-20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA-20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA-20.1 | Systematic Assessment |
|
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 partcipant 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 Inc. | 800-633-1610 | 1# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2018 | Nov 28, 2019 | 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 |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| A/H3N2 |
|
|
| B Victoria |
|
|
| B Yamagata |
|
|
| B Yamagata: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results. | GMT Ratio (QIV-HD/TIV-HDs) | 1.00 | 2-Sided | 95 | 0.881 | 1.129 | Non-Inferiority | Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 0.667 for each of the comparisons. |
| A/H1N1: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results. | GMT Ratio (QIV-HD/TIV-HDs) | 0.83 | 2-Sided | 95 | 0.744 | 0.932 | Non-Inferiority | Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 0.667 for each of the comparisons. |
| A/H3N2: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results. | GMT Ratio (QIV-HD/TIV-HDs) | 0.95 | 2-Sided | 95 | 0.842 | 1.066 | Non-Inferiority | Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 0.667 for each of the comparisons. |
| OG002 | High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0. |
| OG003 | High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled) | Participants randomized to receive either a single injection of 0.5 mL licensed TIV-HD1 or investigational TIV-HD2 by IM route at Day 0. |
|
|
|
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0. |
|
|
|
|
|
|
|
|
|
|
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
|
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|
| Units | Counts |
|---|---|
| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
|
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| OG002 | High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0. |
|
|
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) |
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0. |
|
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| Units | Counts |
|---|---|
| Participants |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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