Trial Outcomes & Findings for A Phase 1/2 Study of a Intramuscular Injection of TAK-850 in Healthy Adult Subjects (NCT NCT02111252)
NCT ID: NCT02111252
Last Updated: 2015-07-27
Results Overview
Number of participants with injection site and systemic adverse events will be tabulated in its own, and by severity and day of onset. Described if solicited adverse event term is different from the PT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
For 22 days
Results posted on
2015-07-27
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 23 March 2014 to 15 April 2014.
Informed consent for the study was obtained from 64 subjects in total. All subjects who gave informed consent were screened for eligibility, and 55 of these subjects were enrolled.
Participant milestones
| Measure |
TAK-850 0.5 mL
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
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|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
55
|
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Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1/2 Study of a Intramuscular Injection of TAK-850 in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
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Age, Continuous
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33.2 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
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Sex: Female, Male
Female
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25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
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Height
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164.8 cm
STANDARD_DEVIATION 7.82 • n=5 Participants
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Weight
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58.95 kg
STANDARD_DEVIATION 7.185 • n=5 Participants
|
|
Body Mass index (BMI)
|
21.66 kg/m^2
STANDARD_DEVIATION 1.563 • n=5 Participants
|
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Influenza Vaccination History Within 1 Year
Yes
|
0 Number of participants
n=5 Participants
|
|
Influenza Vaccination History Within 1 Year
No
|
55 Number of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For 22 daysPopulation: The safety analysis set, comprised the volunteers who received a single dose of 0.5 mL TAK-850, was used.
Number of participants with injection site and systemic adverse events will be tabulated in its own, and by severity and day of onset. Described if solicited adverse event term is different from the PT.
Outcome measures
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Arthralgia
|
1 participants
|
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Number of Participants With Solicited Injection Site and Systemic Adverse Events
Chills
|
2 participants
|
|
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Fatigue
|
1 participants
|
|
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Headache
|
3 participants
|
|
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Injection site ecchymosis (haemorrhage)
|
1 participants
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|
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Injection site pain
|
9 participants
|
|
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Injection site tenderness (Injection site pain)
|
18 participants
|
|
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Malaise
|
9 participants
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|
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Myalgia
|
2 participants
|
|
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Pyrexia
|
1 participants
|
|
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Sweaty (Hyperhidrosis)
|
1 participants
|
PRIMARY outcome
Timeframe: Day 22Population: The full analysis set was used.
Seroprotection rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroprotection Rate was defined as the percentage of participants with HI antibody titer ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Outcome measures
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer
A/H1N1 strain Pre-vaccination (Day 1)
|
34.5 Percentage of participants
Interval 22.237 to 48.581
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Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer
A/H1N1 strain 21 Days Post-vaccination (Day 22)
|
81.8 Percentage of participants
Interval 69.095 to 90.921
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Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer
A/H3N2 strain Pre-vaccination (Day 1)
|
63.6 Percentage of participants
Interval 49.563 to 76.186
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Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer
A/H3N2 strain 21 Days Post-vaccination (Day 22)
|
87.3 Percentage of participants
Interval 75.52 to 94.726
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Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer
B strain Pre-vaccination (Day 1)
|
20.0 Percentage of participants
Interval 10.43 to 32.973
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Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer
B strain 21 Days Post-vaccination (Day 22)
|
76.4 Percentage of participants
Interval 62.98 to 86.772
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PRIMARY outcome
Timeframe: Day 22Seroconversion rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion Rate was defined as the perccentage of participants with a baseline HI antibody titer of ≥ 10 achieving a minimal 4-fold increase, or baseline HI antibody titer of \< 10 achieving an HI antibody titer of ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Outcome measures
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
Seroconversion Rate of HI AntibodyTiter
A/H1N1 strain
|
70.9 Percentage of participants
Interval 57.102 to 82.37
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Seroconversion Rate of HI AntibodyTiter
A/H3N2 strain
|
52.7 Percentage of participants
Interval 38.804 to 66.347
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Seroconversion Rate of HI AntibodyTiter
B strain
|
61.8 Percentage of participants
Interval 47.726 to 74.591
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PRIMARY outcome
Timeframe: Day 22Population: The full analysis set was used.
Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.
Outcome measures
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
Geometric Mean Fold Increase in HI Antibody Titer
A/H3N2 strain
|
6.71 Fold Change
95% Confidence Interval 6.783 • Interval 3.997 to 11.252
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Geometric Mean Fold Increase in HI Antibody Titer
A/H1N1 strain
|
14.74 Fold Change
95% Confidence Interval 7.412 • Interval 8.578 to 25.335
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|
Geometric Mean Fold Increase in HI Antibody Titer
B strain7.14
|
7.14 Fold Change
95% Confidence Interval 5.123 • Interval 4.592 to 11.108
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SECONDARY outcome
Timeframe: Day 1 (Baseline), Day 8, Day 22For continuous variables, summary statistics of measured values and respective changes from baseline will be calculated at each evaluation time point. In addition, figures illustrating individual changes will be created. For discrete variables, shift tables (before and after vaccination) will be created.
Outcome measures
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
Change From Baseline in Blood Pressure
Systolic blood pressure Day 1
|
-1.2 mmHg
Standard Deviation 8.37
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Change From Baseline in Blood Pressure
Systolic blood pressure Day 8
|
-2.1 mmHg
Standard Deviation 9.23
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|
Change From Baseline in Blood Pressure
Systolic blood pressure Day 22
|
0.7 mmHg
Standard Deviation 10.62
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|
Change From Baseline in Blood Pressure
Diastolic blood pressure Day 1
|
-2.0 mmHg
Standard Deviation 6.95
|
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Change From Baseline in Blood Pressure
Diastolic blood pressure Day 8
|
-2.7 mmHg
Standard Deviation 6.79
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|
Change From Baseline in Blood Pressure
Diastolic blood pressure Day 22
|
-2.4 mmHg
Standard Deviation 7.30
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SECONDARY outcome
Timeframe: Day 1 and Day 22The ECG data will be analyzed into 3 categories, 'normal', 'abnormal but not clinically significant' and 'abnormal clinically significant'. Using these variables, shift tables (before and after vaccination) will be created by individual participant. . The definitions for the acronyms are as follows: Within Normal Limits (WNL), Not Clinically Significant (NCS), and Clinically Significant (CS).
Outcome measures
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
Change From Baseline in Safety Electrocardiogram (ECG) Parameters
WNL at Day 1 and WNL at Day 22
|
55 participants
|
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Change From Baseline in Safety Electrocardiogram (ECG) Parameters
WNL ay Day 1 and Abnormal, NCS at Day 22
|
0 participants
|
|
Change From Baseline in Safety Electrocardiogram (ECG) Parameters
WNL at Day 1 and Abnormal, CS at Day 22
|
0 participants
|
|
Change From Baseline in Safety Electrocardiogram (ECG) Parameters
Abnormal, NCS at Day 1 and WNL at Day 22
|
0 participants
|
|
Change From Baseline in Safety Electrocardiogram (ECG) Parameters
Abnormal, NCS at Day 1 and Abnormal NCS at Day 22
|
0 participants
|
|
Change From Baseline in Safety Electrocardiogram (ECG) Parameters
Abnormal, NCS at Day 1 and Abnormal, CS at Day 22
|
0 participants
|
|
Change From Baseline in Safety Electrocardiogram (ECG) Parameters
Abnormal, CS at Day WNL at Day 22
|
0 participants
|
|
Change From Baseline in Safety Electrocardiogram (ECG) Parameters
Abnormal, CS at Day 1 and Abnormal, NCS at Day 22
|
0 participants
|
|
Change From Baseline in Safety Electrocardiogram (ECG) Parameters
Abnormal, CS at Day 1 and Abnormal, CS at Day 22
|
0 participants
|
SECONDARY outcome
Timeframe: Day 22Population: The full analysis set was used.
Geometric mean titer (GMT) of HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination
Outcome measures
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
Geometric Mean Titer (GMT) of HI Antibody Titer
A/H1N1 strain Pre-vaccination (Day 1)
|
17.86 titer
Interval 10.915 to 29.209
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Geometric Mean Titer (GMT) of HI Antibody Titer
A/H1N1 strain 21 Days Post-vaccination (Day 22)
|
263.22 titer
Interval 152.753 to 453.562
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|
Geometric Mean Titer (GMT) of HI Antibody Titer
A/H3N2 strain Pre-vaccination (Day 1)
|
76.07 titer
Interval 42.054 to 137.592
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Geometric Mean Titer (GMT) of HI Antibody Titer
A/H3N2 strain 21 Days Post-vaccination (Day 22)
|
510.11 titer
Interval 299.04 to 870.144
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Geometric Mean Titer (GMT) of HI Antibody Titer
B strain Pre-vaccination (Day 1)
|
8.33 titer
Interval 6.342 to 10.943
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Geometric Mean Titer (GMT) of HI Antibody Titer
B 21 Days Post-vaccination (Day 22)
|
59.49 titer
Interval 39.81 to 88.908
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SECONDARY outcome
Timeframe: Day 22Population: The full analysis set was used.
GMT of single radial hemolysis (SRH) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Outcome measures
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
GMT of Single Radial Hemolysis (SRH) Antibody Titer
A/H1N1 strain Pre-vaccination (Day 1)
|
18.1601 mm^2
Interval 12.95725 to 25.45204
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GMT of Single Radial Hemolysis (SRH) Antibody Titer
A/H1N1 strain 21 Days Post-vaccination (Day 22)
|
71.0170 mm^2
Interval 56.50806 to 89.25123
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GMT of Single Radial Hemolysis (SRH) Antibody Titer
A/H3N2 strain Pre-vaccination (Day 1)
|
7.8348 mm^2
Interval 6.13169 to 10.01108
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GMT of Single Radial Hemolysis (SRH) Antibody Titer
A/H3N2 strain 21 Days Post-vaccination (Day 22)
|
30.7917 mm^2
Interval 23.81308 to 39.81552
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GMT of Single Radial Hemolysis (SRH) Antibody Titer
B strain Pre-vaccination (Day 1)
|
32.8363 mm^2
Interval 24.66069 to 43.72228
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GMT of Single Radial Hemolysis (SRH) Antibody Titer
B strain 21 Days Post-vaccination (Day 22)
|
101.3016 mm^2
Interval 96.47024 to 106.37497
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SECONDARY outcome
Timeframe: Day 22Population: The full analysis set was used.
Seroprotection rate is measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Outcome measures
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
Seroprotection Rate of SRH Antibody Titer
A/H1N1 strain Pre-vaccination (Day 1)
|
50.9 percentage of participants
Interval 37.071 to 64.646
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|
Seroprotection Rate of SRH Antibody Titer
A/H1N1 strain 21 Days Post-vaccination (Day 22)
|
92.7 percentage of participants
Interval 82.413 to 97.983
|
|
Seroprotection Rate of SRH Antibody Titer
A/H3N2 strain Pre-vaccination (Day 1)
|
16.4 percentage of participants
Interval 7.766 to 28.803
|
|
Seroprotection Rate of SRH Antibody Titer
A/H3N2 strain 21 Days Post-vaccination (Day 22)
|
81.8 percentage of participants
Interval 69.095 to 90.921
|
|
Seroprotection Rate of SRH Antibody Titer
B strain Pre-vaccination (Day 1)
|
72.7 percentage of participants
Interval 59.038 to 83.862
|
|
Seroprotection Rate of SRH Antibody Titer
B strain 21 Days Post-vaccination (Day 22)
|
100.0 percentage of participants
Interval 93.513 to 100.0
|
SECONDARY outcome
Timeframe: Day 22Seroconversion rate as measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Outcome measures
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
Seroconversion Rate of SRH Antibody Titer
A/H1N1 strain
|
81.8 percentage of participants
Interval 69.095 to 90.921
|
|
Seroconversion Rate of SRH Antibody Titer
A/H3N2 strain
|
74.5 percentage of participants
Interval 60.997 to 85.33
|
|
Seroconversion Rate of SRH Antibody Titer
B strain
|
78.2 percentage of participants
Interval 64.99 to 88.186
|
SECONDARY outcome
Timeframe: Day 22Geometric mean fold increase in SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.
Outcome measures
| Measure |
TAK-850 0.5 mL
n=55 Participants
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
Geometric Mean Fold Increase in SRH Antibody Titer
A/H1N1 strain
|
3.9106 Fold Change
95% Confidence Interval 2.98684 • Interval 2.90922 to 5.25669
|
|
Geometric Mean Fold Increase in SRH Antibody Titer
A/H3N2 strain
|
3.9301 Fold Change
95% Confidence Interval 2.75769 • Interval 2.9875 to 5.17011
|
|
Geometric Mean Fold Increase in SRH Antibody Titer
B strain
|
3.0851 Fold Change
95% Confidence Interval 2.82759 • Interval 2.32931 to 4.08599
|
Adverse Events
TAK-850 0.5 mL
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-850 0.5 mL
n=55 participants at risk
A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle.
|
|---|---|
|
General disorders
Injection site pain
|
40.0%
22/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
General disorders
Malaise
|
16.4%
9/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
General disorders
Chills
|
3.6%
2/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
General disorders
Injection site pruritus
|
3.6%
2/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
General disorders
Fatigue
|
1.8%
1/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
General disorders
Injection site haemorrhage
|
1.8%
1/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
General disorders
Injection site warmth
|
1.8%
1/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
General disorders
Pyrexia
|
1.8%
1/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
1/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
1/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
2/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
Nervous system disorders
Headache
|
5.5%
3/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.8%
1/55 • From the injection of study drug until 22 days.
The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER