Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers (NCT NCT00127803)
NCT ID: NCT00127803
Last Updated: 2012-09-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Day 0 and up to 7 days post each vaccination
Results posted on
2012-09-14
Participant Flow
Participants were enrolled from 13 July 2005 to 27 July 2005 in 2 medical centers in the US.
A total of 50 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Placebo Group
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
|
Low Dose Vaccine Group
Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
|
Medium Dose Vaccine Group
Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
|
High Dose Vaccine Group
Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
13
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo Group
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
|
Low Dose Vaccine Group
Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
|
Medium Dose Vaccine Group
Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
|
High Dose Vaccine Group
Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
Baseline characteristics by cohort
| Measure |
Placebo Group
n=13 Participants
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
|
Low Dose Vaccine Group
n=13 Participants
Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
|
Medium Dose Vaccine Group
n=12 Participants
Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
|
High Dose Vaccine Group
n=12 Participants
Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
33.6 Years
STANDARD_DEVIATION 12.49 • n=5 Participants
|
30.8 Years
STANDARD_DEVIATION 10.26 • n=7 Participants
|
30.4 Years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
32.6 Years
STANDARD_DEVIATION 9.07 • n=4 Participants
|
31.9 Years
STANDARD_DEVIATION 10.28 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
50 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 and up to 7 days post each vaccinationPopulation: Safety assessments were on the safety population.
Outcome measures
| Measure |
Placebo Group
n=13 Participants
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
|
Low Dose Vaccine Group
n=13 Participants
Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
|
Medium Dose Vaccine Group
n=12 Participants
Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
|
High Dose Vaccine Group
n=12 Participants
Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.
Erythema Day 0
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.
Erythema Day 28
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.
Erythema Day 56
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.
Tenderness Day 0
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.
Tenderness Day 28
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.
Tenderness Day 56
|
0 Participants
|
2 Participants
|
1 Participants
|
1 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 Group
n=13 Participants
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
|
Low Dose Vaccine Group
n=13 Participants
Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
|
Medium Dose Vaccine Group
n=12 Participants
Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
|
High Dose Vaccine Group
n=12 Participants
Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
|
|---|---|---|---|---|
|
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 paraesthesia
|
2 Participants
|
0 Participants
|
0 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 pain
|
8 Participants
|
11 Participants
|
11 Participants
|
12 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
|
2 Participants
|
6 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.
Red blood cells urine positive
|
2 Participants
|
5 Participants
|
6 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.
Protein urine present
|
2 Participants
|
6 Participants
|
4 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.
Eosinophil count increased
|
1 Participants
|
2 Participants
|
5 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
|
4 Participants
|
4 Participants
|
3 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.
Upper respiratory tract infection
|
2 Participants
|
3 Participants
|
2 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.
White blood cells urine positive
|
3 Participants
|
1 Participants
|
3 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.
Pain in extremity
|
5 Participants
|
0 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.
Injection site swelling
|
1 Participants
|
2 Participants
|
3 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.
Diarrhoea
|
3 Participants
|
2 Participants
|
0 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.
Blood urea increased
|
0 Participants
|
1 Participants
|
4 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 induration
|
0 Participants
|
1 Participants
|
4 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.
Abdominal pain
|
1 Participants
|
0 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.
Injection site warmth
|
1 Participants
|
1 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.
Fatigue
|
2 Participants
|
1 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.
Myalgia
|
2 Participants
|
1 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 pruritus
|
0 Participants
|
0 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.
White blood cell count decreased
|
0 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.
Blood potassium increased
|
3 Participants
|
1 Participants
|
0 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.
Sensation of heaviness
|
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 irritation
|
2 Participants
|
0 Participants
|
1 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.
Sinus headache
|
0 Participants
|
2 Participants
|
0 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.
White blood cell count increased
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 28, 56, 70, and 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 in antibody levels from Baseline. For values below the limit of quantification (LLQ) for the assay, the LLQ was used. Serum anti-toxin IgG levels were determined by enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Placebo Group
n=10 Participants
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
|
Low Dose Vaccine Group
n=13 Participants
Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
|
Medium Dose Vaccine Group
n=12 Participants
Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
|
High Dose Vaccine Group
n=11 Participants
Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
|
|---|---|---|---|---|
|
Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Toxin A Day 28
|
0 Participants
|
6 Participants
|
5 Participants
|
10 Participants
|
|
Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Toxin A Day 56
|
0 Participants
|
13 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Toxin A Day 70
|
0 Participants
|
13 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Toxin A Day 236
|
0 Participants
|
12 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Toxin B Day 28
|
0 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Toxin B Day 56
|
0 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Toxin B Day 70
|
0 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Toxin B Day 236
|
0 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
Adverse Events
Placebo Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Low Dose Vaccine Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Medium Dose Vaccine Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
High Dose Vaccine Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Group
n=13 participants at risk
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
|
Low Dose Vaccine Group
n=13 participants at risk
Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
|
Medium Dose Vaccine Group
n=12 participants at risk
Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
|
High Dose Vaccine Group
n=12 participants at risk
Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
|
|---|---|---|---|---|
|
Eye disorders
Eyelid cyst
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
33.3%
4/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
3/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
25.0%
3/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Gastrointestinal disorders
Lip pain
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Asthenia
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Fatigue
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
16.7%
2/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Induration
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site anaesthesia
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site discomfort
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site erythema
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
46.2%
6/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
41.7%
5/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
50.0%
6/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site haemorrhage
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site induration
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
33.3%
4/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
16.7%
2/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site irritation
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site oedema
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site pain
|
61.5%
8/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
84.6%
11/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
91.7%
11/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
100.0%
12/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site paraesthesia
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site pruritus
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
25.0%
3/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site swelling
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
25.0%
3/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
25.0%
3/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Injection site warmth
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
25.0%
3/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Malaise
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Oedema peripheral
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Infections and infestations
Herpes simplex
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
23.1%
3/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
16.7%
2/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
25.0%
3/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Infections and infestations
Viral infection
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Blood calcium increased
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Blood creatinine increased
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Blood potassium decreased
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Blood potassium increased
|
23.1%
3/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Blood urea increased
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
33.3%
4/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
16.7%
2/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Eosinophil count increased
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
41.7%
5/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
25.0%
3/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Protein urine present
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
46.2%
6/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
33.3%
4/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
41.7%
5/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Red blood cell count increased
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Red blood cells urine positive
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
38.5%
5/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
50.0%
6/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
41.7%
5/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
Transaminase increased
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
16.7%
2/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
16.7%
2/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
White blood cell count increased
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Blood and lymphatic system disorders
White blood cells urine positive
|
23.1%
3/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
25.0%
3/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
25.0%
3/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
38.5%
5/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
25.0%
3/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
16.7%
2/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
30.8%
4/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
25.0%
3/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
15.4%
2/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
—
0/0 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Psychiatric disorders
Nervousness
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Reproductive system and breast disorders
Metorrhagia
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
50.0%
1/2 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
8.3%
1/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
7.7%
1/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/13 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
|
0.00%
0/12 • Adverse events data were collected from the day of vaccination 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