Trial Outcomes & Findings for Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector (NCT NCT01765426)
NCT ID: NCT01765426
Last Updated: 2019-07-18
Results Overview
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=\<15 millimeters (mm), 2=15 to 30 mm and 3=\>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
67 participants
Primary outcome timeframe
28 Days after each dose
Results posted on
2019-07-18
Participant Flow
Participants took part in the study at 2 investigative sites in the United States from 15 February 2013 (First participant signed Informed Consent Form) to 26 June 2014 (date of last participant's visit/contact).
Healthy Volunteers were enrolled equally in 1 of 4 treatment groups: Group 1 (2 doses), Group 2 (2 doses) Group 4 (3 doses) of Tetravalent Dengue Vaccine (TDV) using PharmaJet® Injector and Group 3 (2 doses) TDV using needle and syringe.
Participant milestones
| Measure |
Group 1: TDV Using PharmaJet® Injector
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
17
|
15
|
|
Overall Study
Completed All Vaccinations
|
17
|
16
|
17
|
15
|
|
Overall Study
COMPLETED
|
18
|
16
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1: TDV Using PharmaJet® Injector
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector
Baseline characteristics by cohort
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=18 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=17 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=17 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=15 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 8.47 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 8.87 • n=7 Participants
|
30.1 years
STANDARD_DEVIATION 7.90 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 6.84 • n=4 Participants
|
29.9 years
STANDARD_DEVIATION 8.10 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
17 participants
n=5 Participants
|
12 participants
n=4 Participants
|
63 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
12 participants
n=4 Participants
|
52 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
17 participants
n=5 Participants
|
15 participants
n=4 Participants
|
67 participants
n=21 Participants
|
|
Weight
|
78.77 kg
STANDARD_DEVIATION 20.349 • n=5 Participants
|
81.19 kg
STANDARD_DEVIATION 15.673 • n=7 Participants
|
76.72 kg
STANDARD_DEVIATION 13.672 • n=5 Participants
|
73.73 kg
STANDARD_DEVIATION 8.939 • n=4 Participants
|
77.73 kg
STANDARD_DEVIATION 15.354 • n=21 Participants
|
|
Height
|
174.47 cm
STANDARD_DEVIATION 8.934 • n=5 Participants
|
177.58 cm
STANDARD_DEVIATION 9.891 • n=7 Participants
|
179.77 cm
STANDARD_DEVIATION 8.833 • n=5 Participants
|
169.13 cm
STANDARD_DEVIATION 10.593 • n=4 Participants
|
175.41 cm
STANDARD_DEVIATION 10.114 • n=21 Participants
|
|
Body Mass Index (BMI)
|
25.89 kg/m^2
STANDARD_DEVIATION 6.458 • n=5 Participants
|
25.73 kg/m^2
STANDARD_DEVIATION 4.516 • n=7 Participants
|
23.66 kg/m^2
STANDARD_DEVIATION 3.406 • n=5 Participants
|
25.93 kg/m^2
STANDARD_DEVIATION 3.743 • n=4 Participants
|
25.29 kg/m^2
STANDARD_DEVIATION 4.733 • n=21 Participants
|
|
Seropositivity Status at Baseline
Seropositive
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
Seropositivity Status at Baseline
Seronegative
|
17 participants
n=5 Participants
|
13 participants
n=7 Participants
|
16 participants
n=5 Participants
|
13 participants
n=4 Participants
|
59 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 Days after each dosePopulation: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=\<15 millimeters (mm), 2=15 to 30 mm and 3=\>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=18 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=17 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=17 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=15 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Edema, Grade 0 (None)
|
16.7 percentage of participants
|
11.8 percentage of participants
|
11.8 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Edema, Any Severity >Grade 0
|
83.3 percentage of participants
|
88.2 percentage of participants
|
88.2 percentage of participants
|
86.7 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Edema, Grade 1 (Mild)
|
77.8 percentage of participants
|
82.4 percentage of participants
|
76.5 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Erythema, Any Severity >Grade 0
|
88.9 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
93.3 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Erythema, Grade 3 (Severe)
|
0 percentage of participants
|
5.9 percentage of participants
|
5.9 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Itching, Grade 1 (Mild)
|
0 percentage of participants
|
11.8 percentage of participants
|
23.5 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Pain, Grade 0 (None)
|
38.9 percentage of participants
|
41.2 percentage of participants
|
64.7 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Pain, Grade 1 (Mild)
|
61.1 percentage of participants
|
52.9 percentage of participants
|
35.3 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Edema, Grade 2 (Moderate)
|
5.6 percentage of participants
|
5.9 percentage of participants
|
11.8 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Erythema, Grade 0 (None)
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Erythema, Grade 1 (Mild)
|
55.6 percentage of participants
|
23.5 percentage of participants
|
29.4 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Erythema, Grade 2 (Moderate)
|
33.3 percentage of participants
|
70.6 percentage of participants
|
64.7 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Itching, Grade 0 (None)
|
100.0 percentage of participants
|
88.2 percentage of participants
|
76.5 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Itching, Any Severity >Grade 0
|
0 percentage of participants
|
11.8 percentage of participants
|
23.5 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Pain, Any Severity >Grade 0
|
61.1 percentage of participants
|
58.8 percentage of participants
|
35.3 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff
Pain, Grade 2 (Moderate)
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
PRIMARY outcome
Timeframe: 28 Days after each dosePopulation: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant's worst reported severity grade.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=18 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=17 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=17 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=15 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity
Any Severity
|
83.3 percentage of participants
|
76.5 percentage of participants
|
88.2 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity
Grade 4 (Life Threatening)
|
5.6 percentage of participants
|
0 percentage of participants
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity
Grade 1 (Mild)
|
22.2 percentage of participants
|
35.3 percentage of participants
|
52.9 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity
Grade 2 (Moderate)
|
44.4 percentage of participants
|
23.5 percentage of participants
|
17.6 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity
Grade 3 (Severe)
|
11.1 percentage of participants
|
17.6 percentage of participants
|
5.9 percentage of participants
|
6.7 percentage of participants
|
PRIMARY outcome
Timeframe: 14 days after each dosePopulation: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=18 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=17 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=17 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=15 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Temperature, Any Severity >Grade 0
|
5.6 percentage of participants
|
0 percentage of participants
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Nausea, Grade 1 (Mild)
|
16.7 percentage of participants
|
11.8 percentage of participants
|
11.8 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Vomiting, Grade 0 (None)
|
94.4 percentage of participants
|
100.0 percentage of participants
|
94.1 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Vomiting, Any Severity >Grade 0
|
5.6 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Vomiting, Grade 1 (Mild)
|
5.6 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Temperature, Grade 0 (None)
|
94.4 percentage of participants
|
100.0 percentage of participants
|
88.2 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Temperature, Grade 1 (Mild)
|
5.6 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Temperature, Grade 2 (Moderate)
|
0 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Headache, Grade 0 (None)
|
61.1 percentage of participants
|
29.4 percentage of participants
|
41.2 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Headache, Any Severity >Grade 0
|
38.9 percentage of participants
|
70.6 percentage of participants
|
58.8 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Headache, Grade 1 (Mild)
|
22.2 percentage of participants
|
58.8 percentage of participants
|
58.8 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Headache, Grade 2 (Moderate)
|
16.7 percentage of participants
|
11.8 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Muscle Pain, Grade 0 (None)
|
88.9 percentage of participants
|
82.4 percentage of participants
|
76.5 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Muscle Pain, Any Severity >Grade 0
|
11.1 percentage of participants
|
17.6 percentage of participants
|
23.5 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Muscle Pain, Grade 1 (Mild)
|
5.6 percentage of participants
|
17.6 percentage of participants
|
23.5 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Muscle Pain, Grade 2 (Moderate)
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Joint Pain, Grade 0 (None)
|
88.9 percentage of participants
|
88.2 percentage of participants
|
88.2 percentage of participants
|
86.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Joint Pain, Any Severity >Grade 0
|
11.1 percentage of participants
|
11.8 percentage of participants
|
11.8 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Joint Pain, Grade 1 (Mild)
|
5.6 percentage of participants
|
11.8 percentage of participants
|
5.9 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Joint Pain, Grade 2 (Moderate)
|
5.6 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Eye Pain, Grade 0 (None)
|
88.9 percentage of participants
|
94.1 percentage of participants
|
88.2 percentage of participants
|
93.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Eye Pain, Any Severity >Grade 0
|
11.1 percentage of participants
|
5.9 percentage of participants
|
11.8 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Eye Pain, Grade 1 (Mild)
|
11.1 percentage of participants
|
5.9 percentage of participants
|
11.8 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Increased Sensitivity to Light, Grade 0
|
88.9 percentage of participants
|
88.2 percentage of participants
|
88.2 percentage of participants
|
86.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Increased Sensitivity to Light, Severity >Grade 0
|
11.1 percentage of participants
|
11.8 percentage of participants
|
11.8 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Increased Sensitivity to Light, Grade 1 (Mild)
|
11.1 percentage of participants
|
5.9 percentage of participants
|
11.8 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Increased Sensitivity to Light, Grade 2 (Moderate)
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Tiredness, Grade 0 (None)
|
66.7 percentage of participants
|
70.6 percentage of participants
|
47.1 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Tiredness, Any Severity >Grade 0
|
33.3 percentage of participants
|
29.4 percentage of participants
|
52.9 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Tiredness, Grade 1 (Mild)
|
16.7 percentage of participants
|
23.5 percentage of participants
|
41.2 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Tiredness, Grade 2 (Moderate)
|
16.7 percentage of participants
|
5.9 percentage of participants
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Rash Anywhere on Body, Grade 0 (None)
|
94.4 percentage of participants
|
88.2 percentage of participants
|
82.4 percentage of participants
|
93.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Rash Anywhere on Body, Any Severity >Grade 0
|
5.6 percentage of participants
|
11.8 percentage of participants
|
17.6 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Rash Anywhere on Body, Grade 1 (Mild)
|
5.6 percentage of participants
|
11.8 percentage of participants
|
11.8 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Rash Anywhere on Body, Grade 2 (Moderate)
|
0 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Nausea, Grade 0 (None)
|
83.3 percentage of participants
|
88.2 percentage of participants
|
88.2 percentage of participants
|
93.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Nausea, Any Severity >Grade 0
|
16.7 percentage of participants
|
11.8 percentage of participants
|
11.8 percentage of participants
|
6.7 percentage of participants
|
PRIMARY outcome
Timeframe: 14 days after each dosePopulation: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=18 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=17 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=17 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=15 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Swelling, Grade 0 (None)
|
50.0 percentage of participants
|
41.2 percentage of participants
|
35.3 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Swelling, Any Severity >Grade 0
|
50.0 percentage of participants
|
58.8 percentage of participants
|
64.7 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Swelling, Grade 1 (Mild)
|
44.4 percentage of participants
|
47.1 percentage of participants
|
47.1 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Swelling, Grade 2 (Moderate)
|
5.6 percentage of participants
|
11.8 percentage of participants
|
17.6 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Redness, Grade 0
|
22.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Redness, Any Severity >Grade 0
|
77.8 percentage of participants
|
100 percentage of participants
|
100.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Redness, Grade 1 (Mild)
|
44.4 percentage of participants
|
29.4 percentage of participants
|
23.5 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Redness, Grade 2 (Moderate)
|
33.3 percentage of participants
|
64.7 percentage of participants
|
64.7 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Redness, Grade 3 (Severe)
|
0 percentage of participants
|
5.9 percentage of participants
|
11.8 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Itching, Grade 0 (None)
|
66.7 percentage of participants
|
82.4 percentage of participants
|
47.1 percentage of participants
|
73.3 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Itching, Any Severity >Grade 0
|
33.3 percentage of participants
|
17.6 percentage of participants
|
52.9 percentage of participants
|
26.7 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Itching, Grade 1 (Mild)
|
33.3 percentage of participants
|
11.8 percentage of participants
|
52.9 percentage of participants
|
26.7 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Itching, Grade 2 (Moderate)
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Pain, Grade 0 (None)
|
72.2 percentage of participants
|
52.9 percentage of participants
|
76.5 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Pain, Any Severity >Grade 0
|
27.8 percentage of participants
|
47.1 percentage of participants
|
23.5 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity
Pain, Grade 1 (Mild)
|
27.8 percentage of participants
|
47.1 percentage of participants
|
23.5 percentage of participants
|
66.7 percentage of participants
|
PRIMARY outcome
Timeframe: 28 Days after each dosePopulation: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=18 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=17 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=17 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=15 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity
Any Severity
|
16.7 percentage of participants
|
17.6 percentage of participants
|
52.9 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity
Grade 1 (Mild)
|
11.1 percentage of participants
|
11.8 percentage of participants
|
41.2 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity
Grade 2 (Moderate)
|
5.6 percentage of participants
|
0 percentage of participants
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity
Grade 3 (Severe)
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 118 DaysPopulation: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs. Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=18 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=17 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=17 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=15 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)
Alanine aminotransferase increased
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)
Aspartate aminotransferase increased
|
5.6 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)
Blood bilirubin increased
|
5.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)
Blood creatine phosphokinase increased
|
5.6 percentage of participants
|
11.8 percentage of participants
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)
Occult blood
|
0 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 28Population: Per Protocol Set included all randomized participants who completed the study without any major protocol violations.
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=16 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=13 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=16 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=13 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection
DEN-1
|
75.0 percentage of participants
Interval 47.6 to 92.7
|
38.5 percentage of participants
Interval 13.9 to 68.4
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
84.6 percentage of participants
Interval 54.6 to 98.1
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection
DEN-2
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
50.0 percentage of participants
Interval 24.7 to 75.3
|
76.9 percentage of participants
Interval 46.2 to 95.0
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection
DEN-3
|
56.3 percentage of participants
Interval 29.9 to 80.2
|
23.1 percentage of participants
Interval 5.0 to 53.8
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
46.2 percentage of participants
Interval 19.2 to 74.9
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection
DEN-4
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
23.1 percentage of participants
Interval 5.0 to 53.8
|
50.0 percentage of participants
Interval 24.7 to 75.3
|
38.5 percentage of participants
Interval 13.9 to 68.4
|
PRIMARY outcome
Timeframe: Day 118Population: Per Protocol Set included all randomized participants who completed the study without any major protocol violations.
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=16 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=13 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=16 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=13 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection
DEN-1
|
75.0 percentage of participants
Interval 47.6 to 92.7
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
87.5 percentage of participants
Interval 61.7 to 98.4
|
84.6 percentage of participants
Interval 54.6 to 98.1
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection
DEN-2
|
68.8 percentage of participants
Interval 41.3 to 89.0
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
84.6 percentage of participants
Interval 54.6 to 98.1
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection
DEN-3
|
75.0 percentage of participants
Interval 47.6 to 92.7
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
87.5 percentage of participants
Interval 61.7 to 98.4
|
84.6 percentage of participants
Interval 54.6 to 98.1
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection
DEN-4
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
81.3 percentage of participants
Interval 54.4 to 96.0
|
53.8 percentage of participants
Interval 25.1 to 80.8
|
PRIMARY outcome
Timeframe: Dose 1 until 28 days after Dose 2 (Up to Day 118)Population: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=18 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=17 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=17 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=15 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Percentage of Participants With Unsolicited Vaccine-Related SAEs
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0, 28, 90, 118 and 270Population: Per Protocol Set included all randomized participants who completed the study without any major protocol violations.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=16 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=13 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=16 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=13 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 270 DEN-2
|
118.1 titer
Interval 32.2 to 433.0
|
173.3 titer
Interval 41.0 to 732.2
|
54.2 titer
Interval 14.8 to 198.5
|
265.5 titer
Interval 62.9 to 1121.8
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 0 DEN-1
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 0 DEN-2
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 0 DEN-3
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 0 DEN-4
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
5.0 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 28 DEN-1
|
28.3 titer
Interval 13.0 to 61.3
|
10.5 titer
Interval 4.5 to 24.9
|
27.1 titer
Interval 12.5 to 58.7
|
29.0 titer
Interval 12.3 to 68.6
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 28 DEN-2
|
293.4 titer
Interval 48.0 to 1792.9
|
311.6 titer
Interval 41.8 to 2320.7
|
146.7 titer
Interval 24.0 to 896.5
|
1006.9 titer
Interval 135.2 to 7499.7
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 28 DEN-3
|
32.2 titer
Interval 13.2 to 78.7
|
11.1 titer
Interval 4.1 to 30.0
|
10.0 titer
Interval 4.1 to 24.4
|
19.0 titer
Interval 7.0 to 51.1
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 28 DEN-4
|
13.5 titer
Interval 5.0 to 36.4
|
11.7 titer
Interval 3.9 to 35.2
|
32.2 titer
Interval 12.0 to 86.7
|
20.0 titer
Interval 6.7 to 60.0
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 90 DEN-1
|
29.5 titer
Interval 11.8 to 73.9
|
26.1 titer
Interval 9.4 to 72.2
|
28.9 titer
Interval 11.6 to 72.3
|
19.0 titer
Interval 6.9 to 52.4
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 90 DEN-2
|
174.5 titer
Interval 41.3 to 736.7
|
311.6 titer
Interval 63.0 to 1540.0
|
60.4 titer
Interval 14.3 to 254.9
|
560.1 titer
Interval 113.3 to 2768.5
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 90 DEN-3
|
30.2 titer
Interval 13.5 to 67.3
|
22.3 titer
Interval 9.1 to 54.2
|
11.9 titer
Interval 5.3 to 26.5
|
19.0 titer
Interval 7.8 to 46.2
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 90 DEN-4
|
7.1 titer
Interval 3.4 to 14.8
|
11.7 titer
Interval 5.2 to 26.6
|
20.9 titer
Interval 10.0 to 43.7
|
19.0 titer
Interval 8.4 to 43.0
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 118 DEN-1
|
25.9 titer
Interval 11.8 to 56.9
|
21.1 titer
Interval 8.8 to 50.4
|
60.4 titer
Interval 27.5 to 132.3
|
21.1 titer
Interval 8.8 to 50.4
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 118 DEN-2
|
160.0 titer
Interval 40.1 to 638.3
|
220.3 titer
Interval 47.5 to 1022.7
|
89.2 titer
Interval 22.3 to 355.7
|
429.1 titer
Interval 92.4 to 1991.5
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 118 DEN-3
|
30.8 titer
Interval 15.9 to 60.0
|
19.0 titer
Interval 9.1 to 39.7
|
36.7 titer
Interval 18.9 to 71.3
|
32.3 titer
Interval 15.5 to 67.6
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 118 DEN-4
|
8.4 titer
Interval 4.0 to 17.7
|
10.8 titer
Interval 4.7 to 24.8
|
54.2 titer
Interval 25.7 to 114.3
|
22.3 titer
Interval 9.7 to 51.0
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 270 DEN-1
|
16.8 titer
Interval 8.2 to 34.6
|
12.4 titer
Interval 5.6 to 27.5
|
24.8 titer
Interval 12.1 to 51.1
|
10.5 titer
Interval 4.7 to 23.5
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 270 DEN-3
|
21.8 titer
Interval 12.0 to 39.5
|
14.5 titer
Interval 7.5 to 28.1
|
14.8 titer
Interval 8.2 to 26.7
|
14.5 titer
Interval 7.5 to 28.1
|
|
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Day 270 DEN-4
|
8.4 titer
Interval 4.5 to 15.8
|
10.0 titer
Interval 5.0 to 20.1
|
28.3 titer
Interval 15.1 to 53.1
|
13.8 titer
Interval 6.9 to 27.7
|
SECONDARY outcome
Timeframe: Days 90 and 270Population: Per Protocol Set included all randomized participants who completed the study without any major protocol violations.
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=16 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=13 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=16 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=13 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
Day 270 DEN-3
|
68.8 percentage of participants
Interval 41.3 to 89.0
|
53.8 percentage of participants
Interval 25.1 to 80.8
|
75.0 percentage of participants
Interval 47.6 to 92.7
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
Day 90 DEN-1
|
68.8 percentage of participants
Interval 41.3 to 89.0
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
76.9 percentage of participants
Interval 46.2 to 95.0
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
Day 90 DEN-2
|
75.0 percentage of participants
Interval 47.6 to 92.7
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
43.8 percentage of participants
Interval 19.8 to 70.1
|
84.6 percentage of participants
Interval 54.6 to 98.1
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
Day 90 DEN-3
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
43.8 percentage of participants
Interval 19.8 to 70.1
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
Day 90 DEN-4
|
18.8 percentage of participants
Interval 4.0 to 45.6
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
56.3 percentage of participants
Interval 29.9 to 80.2
|
46.2 percentage of participants
Interval 19.2 to 74.9
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
Day 270 DEN-1
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
46.2 percentage of participants
Interval 19.2 to 74.9
|
75.0 percentage of participants
Interval 47.6 to 92.7
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
Day 270 DEN-2
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
50.0 percentage of participants
Interval 24.7 to 75.3
|
84.6 percentage of participants
Interval 54.6 to 98.1
|
|
Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270
Day 270 DEN-4
|
25.0 percentage of participants
Interval 7.3 to 52.4
|
23.1 percentage of participants
Interval 5.0 to 53.8
|
75.0 percentage of participants
Interval 47.6 to 92.7
|
46.2 percentage of participants
Interval 19.2 to 74.9
|
SECONDARY outcome
Timeframe: Day 0 to Day 104Population: Full analysis set included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid sample for immunogenicity (eg, seroconversion) was received.
A quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay was used for detection and serotype identification of dengue viral ribonucleic acid (RNA) that is present in serum. A test for viremia is considered positive if the assay value is \>= 3.6, which is the limit of quantification (LOQ), negative if the assay value was zero, and undetermined if the assay value is \>0 but \<3.6. The percentage of participants with positive results is reported.
Outcome measures
| Measure |
Group 1: TDV Using PharmaJet® Injector
n=18 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=17 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=17 Participants
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=15 Participants
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination
DEN-1
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination
DEN-2
|
38.9 percentage of participants
|
23.5 percentage of participants
|
23.5 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination
DEN-3
|
5.6 percentage of participants
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination
DEN-4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Group 1: TDV Using PharmaJet® Injector
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 2: TDV Using PharmaJet® Injector
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 3: TDV Using Needle and Syringe
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 4: TDV Using PharmaJet® Injector
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 |
Group 1: TDV Using PharmaJet® Injector
n=18 participants at risk
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 2: TDV Using PharmaJet® Injector
n=17 participants at risk
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
Group 3: TDV Using Needle and Syringe
n=17 participants at risk
TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
|
Group 4: TDV Using PharmaJet® Injector
n=15 participants at risk
TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
|
|---|---|---|---|---|
|
General disorders
Injection site haematoma
|
11.1%
2/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
17.6%
3/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Injection site warmth
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
20.0%
3/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Vessel puncture site haematoma
|
11.1%
2/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Vessel puncture site pain
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
11.8%
2/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Immune system disorders
Seasonal allergy
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
11.8%
2/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
4/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
23.5%
4/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
23.5%
4/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
20.0%
3/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
3/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Infections and infestations
Viral infection
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
11.1%
2/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
11.8%
2/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
13.3%
2/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
11.8%
2/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
11.8%
2/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
13.3%
2/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
17.6%
3/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
2/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
11.8%
2/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Eye disorders
Eye irritation
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Chest pain
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Chills
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Feeling abnormal
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Influenza like illness
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Injection site discolouration
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Injection site pain
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Malaise
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Hepatobiliary disorders
Biliary colic
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Infections and infestations
Chlamydial infection
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Infections and infestations
Gingival infection
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
13.3%
2/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Pain
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
General disorders
Pyrexia
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
13.3%
2/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Injury, poisoning and procedural complications
Laceration
|
11.1%
2/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
11.8%
2/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Injury, poisoning and procedural complications
Sunburn
|
11.1%
2/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Investigations
Blood bilirubin increased
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Investigations
Occult blood
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
13.3%
2/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Renal and urinary disorders
Micturition urgency
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
5.9%
1/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
6.7%
1/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
11.8%
2/17 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
0.00%
0/15 • Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor is permitted to protect any proprietary information and to provide comments based on information from other studies that may not be available to the Investigator.
- Publication restrictions are in place
Restriction type: OTHER