Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers (NCT NCT00214461)
NCT ID: NCT00214461
Last Updated: 2012-04-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Day 0 to up to 70 days post first vaccination
Results posted on
2012-04-11
Participant Flow
Participants were enrolled and treated from 01 November 2005 to 11 October 2006 in 3 medical centers in the US.
A total of 48 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Placebo Vaccine Group
Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
|
Low-dose C. Difficile Vaccine Group
Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
Medium-dose C. Difficile Vaccine Group
Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
High-dose C. Difficile Vaccine Group
Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Placebo Vaccine Group
Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
|
Low-dose C. Difficile Vaccine Group
Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
Medium-dose C. Difficile Vaccine Group
Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
High-dose C. Difficile Vaccine Group
Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
Baseline characteristics by cohort
| Measure |
Placebo Vaccine Group
n=12 Participants
Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
|
Low-dose C. Difficile Vaccine Group
n=12 Participants
Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
Medium-dose C. Difficile Vaccine Group
n=12 Participants
Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
High-dose C. Difficile Vaccine Group
n=12 Participants
Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
48 Participants
n=36 Participants
|
|
Age Continuous
|
69.0 Years
STANDARD_DEVIATION 3.59 • n=93 Participants
|
72.2 Years
STANDARD_DEVIATION 5.32 • n=4 Participants
|
75.5 Years
STANDARD_DEVIATION 6.47 • n=27 Participants
|
68.9 Years
STANDARD_DEVIATION 4.32 • n=483 Participants
|
71.4 Years
STANDARD_DEVIATION 5.60 • n=36 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
12 participants
n=4 Participants
|
12 participants
n=27 Participants
|
12 participants
n=483 Participants
|
48 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 0 to up to 70 days post first vaccinationPopulation: Safety assessments were on the safety population.
Outcome measures
| Measure |
Placebo Vaccine Group
n=12 Participants
Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
|
Low-dose C. Difficile Vaccine Group
n=12 Participants
Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
Medium-dose C. Difficile Vaccine Group
n=12 Participants
Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
High-dose C. Difficile Vaccine Group
n=12 Participants
Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Nasopharyngitis
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Blood potassium increased
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Injection site pain
|
3 Participants
|
8 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Eosinophil count increased
|
4 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
White blood cells urine positive
|
3 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Fatigue
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Myalgia
|
2 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Arthralgia
|
2 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Injection site erythema
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Headache
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Back pain
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Blood urea increased
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Diarrhoea
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
White blood cell count increased
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Protein urine present
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Vomiting
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Anorexia
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Red blood cells urine positive
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Haemoglobin decreased
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Injection site warmth
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Red blood cell count decreased
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day up to Day 236 post first vaccinationPopulation: Serum anti-toxin levels were assessed in the fully evaluable (Per-Protocol) population.
Seroconversion was defined as a ≥ 4-fold increase from baseline in a subject's specific IgG levels: Serum Levels of Anti-toxin Immunoglobulin (IgG) against toxin A and toxin B in enzyme units (EU) were assessed by enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Placebo Vaccine Group
n=11 Participants
Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
|
Low-dose C. Difficile Vaccine Group
n=12 Participants
Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
Medium-dose C. Difficile Vaccine Group
n=9 Participants
Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
High-dose C. Difficile Vaccine Group
n=11 Participants
Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
|
|---|---|---|---|---|
|
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Toxin A: Day 28
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Toxin A: Day 14
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Toxin A: Day 56
|
0 Participants
|
6 Participants
|
8 Participants
|
11 Participants
|
|
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Toxin A: Day 70
|
0 Participants
|
11 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Toxin A: Day 236
|
0 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Toxin B: Day 14
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Toxin B: Day 28
|
0 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Toxin B: Day 56
|
0 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Toxin B: Day 70
|
0 Participants
|
7 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Toxin B: Day 236
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Placebo Vaccine Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Low-dose C. Difficile Vaccine Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Medium-dose C. Difficile Vaccine Group
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
High-dose C. Difficile Vaccine Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Vaccine Group
n=12 participants at risk
Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
|
Low-dose C. Difficile Vaccine Group
n=12 participants at risk
Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
Medium-dose C. Difficile Vaccine Group
n=12 participants at risk
Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
High-dose C. Difficile Vaccine Group
n=12 participants at risk
Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
Other adverse events
| Measure |
Placebo Vaccine Group
n=12 participants at risk
Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
|
Low-dose C. Difficile Vaccine Group
n=12 participants at risk
Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
Medium-dose C. Difficile Vaccine Group
n=12 participants at risk
Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
|
High-dose C. Difficile Vaccine Group
n=12 participants at risk
Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Asthenia
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Fatigue
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
25.0%
3/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
33.3%
4/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Induration
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Injection site bruising
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Injection site erythema
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
25.0%
3/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
25.0%
3/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Injection site induration
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Injection site nodule
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Injection site oedema
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Injection site pain
|
25.0%
3/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
66.7%
8/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
33.3%
4/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
66.7%
8/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Injection site pruritus
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Injection site reaction
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Injection site swelling
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Injection site warmth
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Malaise
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Pain
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Blood potassium decreased
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Blood potassium increased
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Blood pressure increased
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Blood urea decreased
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Blood urea increased
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
25.0%
3/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Electrocardiogram ST T Change
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Eosinophil count increased
|
33.3%
4/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
41.7%
5/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
25.0%
3/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
41.7%
5/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Glucose urine
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Haematocrit decreased
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Platelet count decreased
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Platelet count increased
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Prostate examination abnormal
|
0.00%
0/6 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/4 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/7 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
20.0%
1/5 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Protein urine present
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
25.0%
3/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Red blood cell count decreased
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Red blood cell count increased
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
Red blood cells urine positive
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
White blood cell count increased
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Investigations
White blood cells urine positive
|
25.0%
3/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
41.7%
5/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
50.0%
6/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
41.7%
5/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
25.0%
3/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
33.3%
4/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
33.3%
4/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
25.0%
3/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
16.7%
2/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/6 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/4 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
14.3%
1/7 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/5 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolarygeal pain
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
8.3%
1/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
0.00%
0/12 • Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER