Trial Outcomes & Findings for QUILT-3.006 for Recurrent Medullary Thyroid Cancer (NCT NCT01856920)

NCT ID: NCT01856920

Last Updated: 2024-07-09

Results Overview

NCI developed an equation based on the assumption that the change of a tumor's quantity during therapy results from 2 independent component processes: an exponential (first-order kinetics) decrease/regression and an exponential regrowth of the tumor. The equation is f(t) = exp(-d\*t)+exp(g\*t) (A) where exp is the base of the natural logarithm, and f(t) is the MTC calcitonin measurement at time t in days, divided by the tumor measurement at day 0, the time at which treatment is commenced. Rate decay constant d (days\^(-1) )represents the exponential decrease of the tumor marker signal during therapy. Rate growth constant g (days-\^(1) )represents the exponential growth of the tumor during treatment. For each patient an attempt to fit Equation (A) to each data set for which more than one data point is available. Linear regressions to evaluate the relationship between the growth rate constant,g, or other parameters will be implemented using the polynomial linear routine of Sigmaplot 9.0.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: after 6 months of therapy
• Results posted on: 2024-07-09

Participant Flow

Participant milestones

Measure	Surveillance Subjects GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.	Vaccine Subjects 6 months of surveillance followed by GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.
Overall Study STARTED	17	18
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Measure	Surveillance Subjects GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.	Vaccine Subjects 6 months of surveillance followed by GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.
Overall Study Disease Progression On Study	3	4
Overall Study Disease Progression before Treatment	1	0
Overall Study Ineligible	0	1
Overall Study Patient Declined to Participate (before treatment started.)	1	0
Overall Study Refused further Treatment	5	1
Overall Study Other Reasons	0	1
Overall Study Completed treatment phase but refused the Protocol-Specified	0	2

Baseline Characteristics

QUILT-3.006 for Recurrent Medullary Thyroid Cancer

Baseline characteristics by cohort

Measure	Surveillance Subjects n=17 Participants GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.	Vaccine Subjects n=18 Participants 6 months of surveillance followed by GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.	Total n=35 Participants Total of all reporting groups
Age, Continuous	51.4 years STANDARD_DEVIATION 14.50 • n=5 Participants	51.9 years STANDARD_DEVIATION 14.20 • n=7 Participants	51.7 years STANDARD_DEVIATION 14.14 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Patients with recurrent metastatic medullary thyroid cancer	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: after 6 months of therapy

Population: Intent-to-treat: all subjects enrolled in the study regardless of having received treatment

NCI developed an equation based on the assumption that the change of a tumor's quantity during therapy results from 2 independent component processes: an exponential (first-order kinetics) decrease/regression and an exponential regrowth of the tumor. The equation is f(t) = exp(-d*t)+exp(g*t) (A) where exp is the base of the natural logarithm, and f(t) is the MTC calcitonin measurement at time t in days, divided by the tumor measurement at day 0, the time at which treatment is commenced. Rate decay constant d (days^(-1) )represents the exponential decrease of the tumor marker signal during therapy. Rate growth constant g (days-^(1) )represents the exponential growth of the tumor during treatment. For each patient an attempt to fit Equation (A) to each data set for which more than one data point is available. Linear regressions to evaluate the relationship between the growth rate constant,g, or other parameters will be implemented using the polynomial linear routine of Sigmaplot 9.0.

Outcome measures

Measure	Surveillance Subjects n=17 Participants GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.	Vaccine Subjects n=18 Participants 6 months of surveillance followed by GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.
Calcitonin Growth Rate	-2.53 days^-1	-2.49 days^-1

Adverse Events

Surveillance Subjects

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Vaccine Subjects

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Surveillance Subjects n=13 participants at risk GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.	Vaccine Subjects n=17 participants at risk 6 months of surveillance followed by GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Diarrhea	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Nausea	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Vomiting	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
General disorders Neck edema	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.

Other adverse events

Measure	Surveillance Subjects n=13 participants at risk GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.	Vaccine Subjects n=17 participants at risk 6 months of surveillance followed by GI-6207 for 1 year GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.
General disorders Injection site reaction	92.3% 12/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	82.4% 14/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
General disorders Fatigue	69.2% 9/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	47.1% 8/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
General disorders Flu like symptoms	30.8% 4/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	35.3% 6/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
General disorders Pain	30.8% 4/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	35.3% 6/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
General disorders Fever	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	17.6% 3/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
General disorders Neck edema	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
General disorders Non-cardiac chest pain	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hyperglycemia	53.8% 7/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	58.8% 10/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypocalcemia	23.1% 3/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	35.3% 6/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypernatremia	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	29.4% 5/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hyperuricemia	15.4% 2/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	17.6% 3/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypoalbuminemia	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	23.5% 4/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypokalemia	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	23.5% 4/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hyponatremia	23.1% 3/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Dehydration	23.1% 3/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypercalcemia	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypoglycemia	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypomagnesemia	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Anorexia	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Diarrhea	38.5% 5/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	52.9% 9/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Nausea	30.8% 4/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	47.1% 8/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Abdominal pain	15.4% 2/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	23.5% 4/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Vomiting	15.4% 2/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	17.6% 3/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Bloating	15.4% 2/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
General disorders Constipation	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Stomach pain	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations Lymphocyte count decreased	30.8% 4/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	35.3% 6/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations Aspartate aminotransferase increased	23.1% 3/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	23.5% 4/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations Alanine aminotransferase increased	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	29.4% 5/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations Creatinine increased	23.1% 3/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations White blood cell decreased	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	23.5% 4/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations CPK increased	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	23.5% 4/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations Platelet count decreased	15.4% 2/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations Alkaline phosphatase increased	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations Blood bilirubin increased	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations Neutrophil count decreased	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations Lipase increased	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Investigations Serum amylase increased	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Infections and infestations Upper respiratory infection	30.8% 4/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	47.1% 8/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Infections and infestations Urinary tract infection	15.4% 2/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Infections and infestations Sinusitis	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Infections and infestations Infections and infestations - Other, specify	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Infections and infestations Vaginal infection	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	35.3% 6/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Back pain	30.8% 4/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Pain in extremity	15.4% 2/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	17.6% 3/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Nervous system disorders Dizziness	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Nervous system disorders Headache	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	17.6% 3/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Nervous system disorders Peripheral sensory neuropathy	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Nervous system disorders Amnesia	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Nervous system disorders Paresthesia	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Nervous system disorders Facial muscle weakness	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	17.6% 3/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Postnasal drip	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Blood and lymphatic system disorders Anemia	15.4% 2/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	35.3% 6/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Skin and subcutaneous tissue disorders Pruritus	23.1% 3/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Skin and subcutaneous tissue disorders Rash acneiform	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Injury, poisoning and procedural complications Fall	15.4% 2/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Injury, poisoning and procedural complications Fracture	15.4% 2/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Injury, poisoning and procedural complications Bruising	15.4% 2/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Psychiatric disorders Insomnia	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	17.6% 3/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Psychiatric disorders Anxiety	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Vascular disorders Hypotension	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Vascular disorders Flushing	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Vascular disorders Vascular disorders - Other, specify	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Cardiac disorders Palpitations	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	11.8% 2/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Eye disorders Cataract	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Eye disorders Dry eye	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Eye disorders Eye disorders - Other, specify	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Eye disorders Flashing lights	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Ear and labyrinth disorders Ear pain	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Endocrine disorders Hyperthyroidism	7.7% 1/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	0.00% 0/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Reproductive system and breast disorders Menorrhagia	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.00% 0/13 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.	5.9% 1/17 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, were to be followed until return to baseline or stabilization of event (up to 2 years). Serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention and have an attribution of at least possibly related to the agent/intervention were to be recorded (Up to 2 years) The safety population was used for all adverse event summaries (serious adverse events and non-serious adverse events). Only 13/17 surveillance subjects and 17/18 vaccine subjects received at least one dose of study drug and were included in the safety population.

Additional Information

Sandeep Bobby Reddy, Chief Medical Office

ImmunityBio

Phone: 855-797-9277

Email: Bobby.Reddy@immunitybio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place