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Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations

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ClinicalTrials.gov Identifier: NCT02908269
Recruitment Status : Completed
First Posted : September 20, 2016
Results First Posted : January 8, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative
Biological: Fluzone High-Dose, vaccine, 2016-2017 formulation
Enrollment 180
Recruitment Details Study participants were enrolled in 2 centers in the United States from 15 September 2016 to 28 September 2016.
Pre-assignment Details A total of 180 participants (60 for each group) were enrolled and vaccinated in the study.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years Fluzone High-Dose Vaccine Group 3: ≥ 65 Years
Hide Arm/Group Description Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Period Title: Overall Study
Started 60 60 60
Completed 60 60 60
Not Completed 0 0 0
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years Fluzone High-Dose Vaccine Group 3: ≥ 65 Years Total
Hide Arm/Group Description Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 60 60 60 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 60 participants 180 participants
6.03  (1.61) 42.2  (12.9) 72.6  (6.19) 40.3  (28.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Female 26 42 45 113
Male 34 18 15 67
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 60 participants 60 participants 180 participants
60 60 60 180
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age)
Hide Description Solicited injection site reactions: Pain (Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities), erythema & swelling (Grade 1: >0 to <25 mm;Grade 2: ≥ 25 to < 50 mm; Grade 3: ≥ 50 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported.
Time Frame Within 7 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using the Safety Analysis Set, which included all participants who received the study vaccine. Number of participants analyzed corresponds to participants with available data for the listed solicited reaction.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years
Hide Arm/Group Description:
Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Any Injection site pain Number Analyzed 58 participants
18
  31.0%
Grade 3 Injection site pain Number Analyzed 58 participants
1
   1.7%
Any Injection site erythema Number Analyzed 58 participants
6
  10.3%
Grade3 Injection site erythema Number Analyzed 58 participants
0
   0.0%
Any Injection site swelling Number Analyzed 58 participants
7
  12.1%
Grade3 Injection site swelling Number Analyzed 58 participants
0
   0.0%
Any Fever Number Analyzed 57 participants
3
   5.3%
Grade 3 Fever Number Analyzed 57 participants
1
   1.8%
Any Headache Number Analyzed 57 participants
9
  15.8%
Grade 3 Headache Number Analyzed 57 participants
0
   0.0%
Any Malaise Number Analyzed 57 participants
15
  26.3%
Grade 3 Malaise Number Analyzed 57 participants
1
   1.8%
Any Myalgia Number Analyzed 57 participants
12
  21.1%
Grade 3 Myalgia Number Analyzed 57 participants
0
   0.0%
2.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years)
Hide Description Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant; prevents daily activity), erythema & swelling (Grade 1: ≥ 25 to ≤ 50 mm; Grade 2: ≥ 51 to ≤ 100 mm; Grade 3: >100 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported.
Time Frame Within 7 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years Fluzone High-Dose Vaccine Group 3: ≥ 65 Years
Hide Arm/Group Description:
Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Any Injection site pain
28
  46.7%
12
  20.0%
Grade 3 Injection site pain
0
   0.0%
0
   0.0%
Any Injection site erythema
0
   0.0%
3
   5.0%
Grade3 Injection site erythema
0
   0.0%
0
   0.0%
Any Injection site swelling
0
   0.0%
1
   1.7%
Grade3 Injection site swelling
0
   0.0%
0
   0.0%
Any Fever
0
   0.0%
1
   1.7%
Grade 3 Fever
0
   0.0%
0
   0.0%
Any Headache
11
  18.3%
8
  13.3%
Grade 3 Headache
0
   0.0%
0
   0.0%
Any Malaise
10
  16.7%
4
   6.7%
Grade 3 Malaise
0
   0.0%
0
   0.0%
Any Myalgia
15
  25.0%
11
  18.3%
Grade 3 Myalgia
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years)
Hide Description Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.
Time Frame Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using the Per-protocol Analysis Set (PPAS), which included all participants who received study vaccine and had a valid post-vaccination serology result for at least 1 strain.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years
Hide Arm/Group Description:
Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
Overall Number of Participants Analyzed 54
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Pre-Vaccination: A/H1N1 Number Analyzed 54 participants
273
(177 to 419)
Pre-Vaccination: A/H3N2 Number Analyzed 54 participants
167
(106 to 265)
Pre-Vaccination: B Victoria Number Analyzed 53 participants
111
(63.1 to 195)
Pre-Vaccination: B Yamagata Number Analyzed 54 participants
170
(103 to 279)
Post-Vaccination: A/H1N1 Number Analyzed 54 participants
1232
(961 to 1579)
Post-Vaccination: A/H3N2 Number Analyzed 54 participants
2495
(1893 to 3289)
Post-Vaccination: B Victoria Number Analyzed 54 participants
1208
(807 to 1809)
Post-Vaccination: B Yamagata Number Analyzed 54 participants
1731
(1230 to 2435)
4.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years)
Hide Description Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.
Time Frame Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years
Hide Arm/Group Description:
Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Pre-Vaccination: A/H1N1
225
(151 to 335)
Pre-Vaccination: A/H3N2
66.1
(45.7 to 95.6)
Pre-Vaccination: B Victoria
195
(136 to 278)
Pre-Vaccination: B Yamagata
264
(181 to 386)
Post-Vaccination: A/H1N1
779
(584 to 1039)
Post-Vaccination: A/H3N2
752
(562 to 1006)
Post-Vaccination: B Victoria
998
(787 to 1267)
Post-Vaccination: B Yamagata
1470
(1114 to 1941)
5.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years)
Hide Description Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 strains: H1N1, H3N2, Victoria lineage.
Time Frame Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS.
Arm/Group Title Fluzone High-Dose Vaccine Group 3: ≥ 65 Years
Hide Arm/Group Description:
Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Pre-Vaccination: A/H1N1
77.3
(51.8 to 115)
Pre-Vaccination: A/H3N2
59.6
(39.6 to 89.6)
Pre-Vaccination: B Victoria
106
(77.4 to 146)
Post-Vaccination: A/H1N1
347
(249 to 484)
Post-Vaccination: A/H3N2
590
(406 to 858)
Post-Vaccination: B Victoria
816
(607 to 1097)
6.Secondary Outcome
Title Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years)
Hide Description Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.
Time Frame Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years
Hide Arm/Group Description:
Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28.
Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Vaccination: A/H1N1 Number Analyzed 54 participants
46
  85.2%
Pre-Vaccination: A/H3N2 Number Analyzed 54 participants
47
  87.0%
Pre-Vaccination: B Victoria Number Analyzed 53 participants
35
  66.0%
Pre-Vaccination: B Yamagata Number Analyzed 54 participants
41
  75.9%
Post-Vaccination: A/H1N1 Number Analyzed 54 participants
54
 100.0%
Post-Vaccination: A/H3N2 Number Analyzed 54 participants
54
 100.0%
Post-Vaccination: B Victoria Number Analyzed 54 participants
52
  96.3%
Post-Vaccination: B Yamagata Number Analyzed 54 participants
53
  98.1%
7.Secondary Outcome
Title Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years)
Hide Description Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.
Time Frame Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years
Hide Arm/Group Description:
Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Vaccination: A/H1N1
53
  88.3%
Pre-Vaccination: A/H3N2
40
  66.7%
Pre-Vaccination: B Victoria
52
  86.7%
Pre-Vaccination: B Yamagata
56
  93.3%
Post-Vaccination: A/H1N1
60
 100.0%
Post-Vaccination: A/H3N2
60
 100.0%
Post-Vaccination: B Victoria
60
 100.0%
Post-Vaccination: B Yamagata
60
 100.0%
8.Secondary Outcome
Title Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years)
Hide Description Anti-influenza antibodies were measured using HAI assay for 3 strains: H1N1, H3N2, Victoria lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.
Time Frame Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS.
Arm/Group Title Fluzone High-Dose Vaccine Group 3: ≥ 65 Years
Hide Arm/Group Description:
Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Vaccination: A/H1N1
41
  68.3%
Pre-Vaccination: A/H3N2
39
  65.0%
Pre-Vaccination: B Victoria
51
  85.0%
Post-Vaccination: A/H1N1
56
  93.3%
Post-Vaccination: A/H3N2
58
  96.7%
Post-Vaccination: B Victoria
60
 100.0%
Time Frame Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Group 1; up to Day 21 for Groups 2 and 3.
Adverse Event Reporting Description

A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF.

An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.

 
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years Fluzone High-Dose Vaccine Group 3: ≥ 65 Years
Hide Arm/Group Description Participants aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second dose of Fluzone Quadrivalent vaccine was administered at Day 28. Participants aged 18 to < 65 years received one 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants aged ≥ 65 years received one 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
All-Cause Mortality
Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years Fluzone High-Dose Vaccine Group 3: ≥ 65 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%)   0/60 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years Fluzone High-Dose Vaccine Group 3: ≥ 65 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/60 (1.67%)   0/60 (0.00%)   2/60 (3.33%) 
Cardiac disorders       
Atrial fibrillation  1  0/60 (0.00%)  0/60 (0.00%)  1/60 (1.67%) 
Infections and infestations       
Pneumonia  1  0/60 (0.00%)  0/60 (0.00%)  1/60 (1.67%) 
Sepsis  1  0/60 (0.00%)  0/60 (0.00%)  1/60 (1.67%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal chest pain  1  0/60 (0.00%)  0/60 (0.00%)  1/60 (1.67%) 
Renal and urinary disorders       
Acute kidney injury  1  0/60 (0.00%)  0/60 (0.00%)  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/60 (1.67%)  0/60 (0.00%)  0/60 (0.00%) 
1
Term from vocabulary, MedDra 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years Fluzone High-Dose Vaccine Group 3: ≥ 65 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/60 (58.33%)   33/60 (55.00%)   25/60 (41.67%) 
General disorders       
Injection site erythema  1  6/60 (10.00%)  0/60 (0.00%)  3/60 (5.00%) 
Injection site pain  1  18/60 (30.00%)  28/60 (46.67%)  12/60 (20.00%) 
Injection site swelling  1  7/60 (11.67%)  0/60 (0.00%)  1/60 (1.67%) 
Malaise  1  15/60 (25.00%)  10/60 (16.67%)  4/60 (6.67%) 
Pyrexia  1  5/60 (8.33%)  0/60 (0.00%)  1/60 (1.67%) 
Infections and infestations       
Bronchiolitis  1  3/60 (5.00%)  0/60 (0.00%)  0/60 (0.00%) 
Pharyngitis streptococcal  1  4/60 (6.67%)  0/60 (0.00%)  0/60 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  12/60 (20.00%)  15/60 (25.00%)  12/60 (20.00%) 
Nervous system disorders       
Headache  1  9/60 (15.00%)  11/60 (18.33%)  8/60 (13.33%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  6/60 (10.00%)  0/60 (0.00%)  0/60 (0.00%) 
Oropharyngeal pain  1  3/60 (5.00%)  0/60 (0.00%)  0/60 (0.00%) 
1
Term from vocabulary, MedDra 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject 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.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02908269     History of Changes
Other Study ID Numbers: GRC71
U1111-1174-4738 ( Other Identifier: WHO )
First Submitted: September 16, 2016
First Posted: September 20, 2016
Results First Submitted: December 8, 2017
Results First Posted: January 8, 2018
Last Update Posted: February 2, 2018