Trial Outcomes & Findings for ADXS 11-001 Vaccination Prior to Robotic Surgery, HPV-Positive Oropharyngeal Cancer (NCT NCT02002182)
NCT ID: NCT02002182
Last Updated: 2022-09-22
Results Overview
Response rate defined as proportion of participants with a \>2-fold increase in HPV-specific T cell response from baseline to time of surgery.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
At time of surgery
Results posted on
2022-09-22
Participant Flow
Participant milestones
| Measure |
Treatment-Vaccine Group
Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10\^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.
ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.
|
Control Group
Observational control group treated with standard of care therapy only
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Treatment-Vaccine Group
Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10\^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.
ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.
|
Control Group
Observational control group treated with standard of care therapy only
|
|---|---|---|
|
Overall Study
Withdraw from study
|
3
|
1
|
|
Overall Study
Health Reasons
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
ADXS 11-001 Vaccination Prior to Robotic Surgery, HPV-Positive Oropharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Treatment-Vaccine Group
n=9 Participants
Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10\^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.
ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.
|
Control Group
n=6 Participants
Observational control group treated with standard of care therapy only
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=99 Participants
|
53 years
n=107 Participants
|
62 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At time of surgeryPopulation: The analysis included participants who had HPV-specific T cell response measurement at time of surgery. T cell response data were not collected at time of surgery for the control group, which was an optional observational group.
Response rate defined as proportion of participants with a \>2-fold increase in HPV-specific T cell response from baseline to time of surgery.
Outcome measures
| Measure |
Treatment-Vaccine Group
n=9 Participants
Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10\^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.
ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.
|
Control Group
Observational control group treated with standard of care therapy only
|
|---|---|---|
|
HPV-Specific T Cell Response Rate
|
0.333 proportion of participants
Interval 0.075 to 0.701
|
—
|
PRIMARY outcome
Timeframe: Assessed up to 30 Days after surgeryPopulation: All participants were included in the analysis.
Degree of toxicity assessed according to NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.
Outcome measures
| Measure |
Treatment-Vaccine Group
n=9 Participants
Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10\^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.
ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.
|
Control Group
n=6 Participants
Observational control group treated with standard of care therapy only
|
|---|---|---|
|
Number of Participants With Any Grade 3 or 4 Toxicity
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed up to 3 months after surgeryPopulation: The analysis included participants who had at least one HPV-specific T cell response measurement post surgery.
Response rate defined as proportion of participants with a \>2-fold increase in HPV-specific T cell response from baseline to 3 months after surgery.
Outcome measures
| Measure |
Treatment-Vaccine Group
n=8 Participants
Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10\^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.
ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.
|
Control Group
n=4 Participants
Observational control group treated with standard of care therapy only
|
|---|---|---|
|
HPV-Specific T Cell Response Rate
|
0.625 proportion of participants
Interval 0.245 to 0.915
|
0.75 proportion of participants
Interval 0.194 to 0.994
|
Adverse Events
Treatment-Vaccine Group
Serious events: 5 serious events
Other events: 9 other events
Deaths: 1 deaths
Control Group
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment-Vaccine Group
n=9 participants at risk
Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10\^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.
ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.
|
Control Group
n=6 participants at risk
Observational control group treated with standard of care therapy only
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
11.1%
1/9 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Vomitting
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Failure to thrive
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Mouth pain
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Pain in throat and left ear when swollowing
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Skin and subcutaneous tissue disorders
mucositis
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
Other adverse events
| Measure |
Treatment-Vaccine Group
n=9 participants at risk
Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10\^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.
ADXS11-001 (ADXS-HPV): ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.
|
Control Group
n=6 participants at risk
Observational control group treated with standard of care therapy only
|
|---|---|---|
|
Nervous system disorders
headache
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Blood and lymphatic system disorders
Decreased WBCs
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
1/9 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Blood and lymphatic system disorders
Localized edema
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Blood and lymphatic system disorders
Monocytosis
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Blood and lymphatic system disorders
lymphedema
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Cardiac disorders
Hypertension
|
22.2%
2/9 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Cardiac disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Cardiac disorders
Tachycardia
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Cardiac disorders
Tachycardia (HR112)
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Cardiac disorders
Tachychardia
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Endocrine disorders
Face Flushing
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Endocrine disorders
Flushed Face
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Endocrine disorders
Flushing
|
22.2%
2/9 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Endocrine disorders
Flushing (face+neck)
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Endocrine disorders
Sweating
|
22.2%
2/9 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Constipation
|
66.7%
6/9 • Number of events 7 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
33.3%
2/6 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Difficulty with swallowing solid food
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Dysphagia
|
77.8%
7/9 • Number of events 12 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Intermittent diarrhea after taking Bactrim
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 7 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
33.3%
2/6 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Upset Stomach
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
33.3%
2/6 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
Vomitting
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Gastrointestinal disorders
tongue ulcer
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Anorexia
|
33.3%
3/9 • Number of events 3 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Body ache
|
33.3%
3/9 • Number of events 3 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Chill
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Chills
|
77.8%
7/9 • Number of events 10 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Dry Mouth
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Dry mouth
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
33.3%
2/6 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Ear pain
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Fatigue
|
55.6%
5/9 • Number of events 8 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Fever
|
55.6%
5/9 • Number of events 7 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Intermittent throat pain when swallowing
|
11.1%
1/9 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Jaw pain
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Left Ear Pain
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Mild discomfort in the throat on the left side
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Mild odynophagia
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Mild throat pain
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Neck Mass
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Occasional fatigue
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Occasional pain in throat
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
50.0%
3/6 • Number of events 3 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Pain (in neck)
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Pain (in throat)
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Pain in left jaw
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Pain in legs
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Pain in neck
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Pain in right ear
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Pain in right ear,nec
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Pain in right shoulder
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Pain in right side of neck
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Right Neck Pain
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Right Shoulder Pain
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Shivering
|
11.1%
1/9 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Slight sore throat
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Throat pain
|
22.2%
2/9 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Tonsillar Pain
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Weakening
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
Xerostomia
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
dry saliva
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
left buccal mucosa lump
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
minor discomfort when swallowing
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
pain in right neck
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
pain in right neck, shoulder
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
pain in shoulder
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
pain in throat
|
33.3%
3/9 • Number of events 5 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
pressure in the right neck
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
slight tightness on outside of left neck at surgical site when out in the cold only
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
General disorders
tooth decay
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Metabolism and nutrition disorders
Gout
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Musculoskeletal and connective tissue disorders
Intermittent neck stiffness
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Musculoskeletal and connective tissue disorders
cramping in feet
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Nervous system disorders
Decreased taste
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Nervous system disorders
Dysgeusia
|
22.2%
2/9 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • Number of events 5 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Nervous system disorders
Headache Intermittent
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Nervous system disorders
Loss of taste
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Nervous system disorders
Memory loss and cognitive decline
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Nervous system disorders
Numbness right Ear,Neck and back of head
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Nervous system disorders
dysgeusia
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Psychiatric disorders
Euphoria
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Respiratory, thoracic and mediastinal disorders
Blood tinged sputum
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
33.3%
2/6 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Respiratory, thoracic and mediastinal disorders
Voice Change
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Respiratory, thoracic and mediastinal disorders
voice changes
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Skin and subcutaneous tissue disorders
Mucositis
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
2/9 • Number of events 2 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Skin and subcutaneous tissue disorders
Rash (chest, back of neck)
|
11.1%
1/9 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
0.00%
0/6 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Skin and subcutaneous tissue disorders
left lump posterior pharyngeal region
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Skin and subcutaneous tissue disorders
radiation associated dermatitis
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
|
Skin and subcutaneous tissue disorders
tender left arm lump
|
0.00%
0/9 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
16.7%
1/6 • Number of events 1 • Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place