Trial Outcomes & Findings for Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity (NCT NCT01728792)
NCT ID: NCT01728792
Last Updated: 2019-07-18
Results Overview
Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=\<2.5 centimeters (cm) to 3=Severe: \>10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number 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. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
For 14 days after each vaccination (Up to Day 14 and/or Day 104)
Results posted on
2019-07-18
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 22 January 2013 to 21 November 2013.
Healthy participants were randomized equally to 1 of 5 TDV treatment groups: 2 doses subcutaneous (SC) on Day 0 using needle/syringe, 2 doses intramuscular (IM) on Day 0 using needle/syringe, 1 dose IM on Days 0 and 90 using needle/syringe, 2 doses SC on Day 0 using the PharmaJet Stratis™ device and 2 doses IM on Day 0 using the PharmaJet Stratis™.
Participant milestones
| Measure |
Group 1: TDV SC_ 2 Doses Day 0
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 2: TDV IM_2 Doses Day 0
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 3: TDV IM_2 Doses Days 0 and 90
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
|
Group 4: TDV SC_2 Doses Day 0
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Group 5: TDV IM_2 Doses Day 0
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
17
|
17
|
16
|
|
Overall Study
COMPLETED
|
11
|
14
|
13
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
4
|
3
|
0
|
Reasons for withdrawal
| Measure |
Group 1: TDV SC_ 2 Doses Day 0
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 2: TDV IM_2 Doses Day 0
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 3: TDV IM_2 Doses Days 0 and 90
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
|
Group 4: TDV SC_2 Doses Day 0
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Group 5: TDV IM_2 Doses Day 0
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal of Consent
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
4
|
2
|
0
|
Baseline Characteristics
Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity
Baseline characteristics by cohort
| Measure |
Group 1: TDV SC_ 2 Doses Day 0
n=14 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 2: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 3: TDV IM_2 Doses Days 0 and 90
n=17 Participants
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
|
Group 4: TDV SC_2 Doses Day 0
n=17 Participants
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Group 5: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 5.81 • n=5 Participants
|
30.2 years
STANDARD_DEVIATION 7.49 • n=7 Participants
|
27.5 years
STANDARD_DEVIATION 7.92 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 7.48 • n=4 Participants
|
30.8 years
STANDARD_DEVIATION 7.79 • n=21 Participants
|
29.4 years
STANDARD_DEVIATION 7.31 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
4 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
16 participants
n=4 Participants
|
16 participants
n=21 Participants
|
76 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
1 participants
n=21 Participants
|
10 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
12 participants
n=5 Participants
|
13 participants
n=4 Participants
|
13 participants
n=21 Participants
|
63 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
17 participants
n=4 Participants
|
16 participants
n=21 Participants
|
80 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: For 14 days after each vaccination (Up to Day 14 and/or Day 104)Population: Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.
Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=\<2.5 centimeters (cm) to 3=Severe: \>10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number 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. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.
Outcome measures
| Measure |
Group 1: TDV SC_ 2 Doses Day 0
n=14 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 2: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 3: TDV IM_2 Doses Days 0 and 90
n=17 Participants
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
|
Group 4: TDV SC_2 Doses Day 0
n=17 Participants
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Group 5: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Erythema_Any Grade
|
2 participants
|
0 participants
|
0 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Erythema_Grade 1
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
3 participants
|
|
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Erythema_Grade 2
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Edema_Any Grade
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Pain_Any Grade
|
1 participants
|
5 participants
|
7 participants
|
6 participants
|
7 participants
|
|
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Pain_Grade 2
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Itching_Any Grade
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Itching_Grade 1
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Pain_Grade 1
|
1 participants
|
5 participants
|
6 participants
|
5 participants
|
7 participants
|
|
Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Itching_Grade 2
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: For 14 days after each vaccination (Up to Day 14 and/or Day 104)Population: Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.
Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=\< 2.5 cm to 3= Severe: \> 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.
Outcome measures
| Measure |
Group 1: TDV SC_ 2 Doses Day 0
n=14 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 2: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 3: TDV IM_2 Doses Days 0 and 90
n=17 Participants
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
|
Group 4: TDV SC_2 Doses Day 0
n=17 Participants
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Group 5: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Erythema_Any Grade (n=9,10,14,14,13)
|
3 participants
|
0 participants
|
0 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Erythema_Grade 1 (n=9,10,14,14,13)
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Erythema_Grade 2 (n=9,10,14,14,13)
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Edema_Any Grade (n=8,10,14,12,12)
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Edema_Grade 1 (n=8,10,14,12,12)
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Pain_Any Grade (n=13,16,17,17,16)
|
10 participants
|
7 participants
|
8 participants
|
11 participants
|
10 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Pain_Grade 1 (n=13,16,17,17,16)
|
7 participants
|
7 participants
|
8 participants
|
9 participants
|
7 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Itching_Any Grade (n=13,15,17,17,16)
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Erythema_Grade 3 (n=9,10,14,14,13)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Edema_Grade 2 (n=8,10,14,12,12)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Pain_Grade 2 (n=13,16,17,17,16)
|
3 participants
|
0 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Itching_Grade 1 (n=13,15,17,17,16)
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Itching_Grade 2 (n=13,15,17,17,16)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: For 14 days after each vaccination (Up to Day 14 and/or Day 104)Population: Participants from the Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.
Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.
Outcome measures
| Measure |
Group 1: TDV SC_ 2 Doses Day 0
n=14 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 2: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 3: TDV IM_2 Doses Days 0 and 90
n=17 Participants
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
|
Group 4: TDV SC_2 Doses Day 0
n=17 Participants
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Group 5: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Fever_Any Grade (n=13,16,17,17,16)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Headache_Any Grade
|
3 participants
|
3 participants
|
9 participants
|
6 participants
|
5 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Headache_Grade 2
|
0 participants
|
0 participants
|
5 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Headache_Grade 3
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Myalgia_Grade 1
|
2 participants
|
2 participants
|
1 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Myalgia_Grade 2
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Arthralgia_Any Grade
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Arthralgia_Grade 1
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Arthralgia_Grade 2
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Eye Pain_Any Grade
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Photophobia_Any Grade
|
2 participants
|
1 participants
|
4 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Photophobia_Grade 1
|
2 participants
|
0 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Photophobia_Grade 2
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Fatigue_Any Grade
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
2 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Fatigue_Grade 1
|
3 participants
|
4 participants
|
1 participants
|
6 participants
|
1 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Fatigue_Grade 2
|
3 participants
|
1 participants
|
5 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Rash_Any Grade
|
1 participants
|
0 participants
|
3 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Rash_Grade 1
|
1 participants
|
0 participants
|
3 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Rash_Grade 2
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Nausea_Any Grade
|
3 participants
|
3 participants
|
4 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Nausea_Grade1
|
2 participants
|
2 participants
|
2 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Nausea_Grade 2
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Nausea_Grade 3
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Vomiting_Any Grade
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Headache_Grade 1
|
3 participants
|
2 participants
|
3 participants
|
5 participants
|
3 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Myalgia_Any Grade
|
2 participants
|
2 participants
|
3 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Fatigue_Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)Population: Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.
Outcome measures
| Measure |
Group 1: TDV SC_ 2 Doses Day 0
n=14 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 2: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 3: TDV IM_2 Doses Days 0 and 90
n=17 Participants
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
|
Group 4: TDV SC_2 Doses Day 0
n=17 Participants
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Group 5: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose
|
1 participants
|
2 participants
|
2 participants
|
3 participants
|
3 participants
|
PRIMARY outcome
Timeframe: First Vaccination to End of Study (Up to Day 120)Population: Safety Analysis Set includes all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Outcome measures
| Measure |
Group 1: TDV SC_ 2 Doses Day 0
n=14 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 2: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 3: TDV IM_2 Doses Days 0 and 90
n=17 Participants
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
|
Group 4: TDV SC_2 Doses Day 0
n=17 Participants
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Group 5: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least 1 Serious Adverse Event During the Study
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)Population: Protocol deviations results in testing not performed for outcome measure.
Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 0, 7, 9, 11, 14, 17, 21, 90, 97 and 104Population: Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine, with data available at the given time-point.
Viral RNA was assessed for the four dengue components: Dengue-1 (TDV-1), Dengue-2 (TDV-2), Dengue-3 (TDV-3) and Dengue-4 (TDV-4). Only those time-points where at least 1 participant had Viral RNA detected are reported. Baseline (Day 0) and Day 7 are added for reference. "n" in each of the categories is the number of participants with data available.
Outcome measures
| Measure |
Group 1: TDV SC_ 2 Doses Day 0
n=14 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 2: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 3: TDV IM_2 Doses Days 0 and 90
n=17 Participants
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
|
Group 4: TDV SC_2 Doses Day 0
n=17 Participants
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Group 5: TDV IM_2 Doses Day 0
n=16 Participants
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
|---|---|---|---|---|---|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 14_TDV-2 (n=6,8,7,10,9)
|
2 participants
|
3 participants
|
1 participants
|
9 participants
|
3 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 17_TDV-1, TDV-3, TDV-4 (n=7,8,9,8,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 17_TDV-2 (n=7,8,9,8,7)
|
4 participants
|
2 participants
|
2 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 21_TDV-1, TDV-3, TDV-4 (n=6,8,8,9,9)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 21_TDV-2 (n=6,8,8,9,9)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 0_TDV-1, TDV-2, TDV-3, TDV-4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 7_TDV-1, TDV-2, TDV-3, TDV-4 (n=7,8,9,8,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 9 _TDV-2 (n=6,8,7,9,9)
|
3 participants
|
2 participants
|
1 participants
|
5 participants
|
3 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 11_TDV-1, TDV-3 (n=7,8,9,7,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 11_TDV-2 (n=7,8,9,7,7)
|
3 participants
|
5 participants
|
4 participants
|
3 participants
|
3 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 11_TDV-4 (n=7,8,9,7,7)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 14_TDV-1, TDV-3, TDV-4 (n=6,8,7,10,9)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Day 9_TDV-1, TDV-3, TDV-4 (n=6,8,7,9,9)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 28, 90 and 120 after 1st vaccinationPopulation: Protocol deviations results in testing not performed for outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Group 1: TDV SC_ 2 Doses Day 0
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2: TDV IM_2 Doses Day 0
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 3: TDV IM_2 Doses Days 0 and 90
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 4: TDV SC_2 Doses Day 0
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 5: TDV IM_2 Doses Day 0
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: TDV SC_ 2 Doses Day 0
n=14 participants at risk
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 2: TDV IM_2 Doses Day 0
n=16 participants at risk
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 3: TDV IM_2 Doses Days 0 and 90
n=17 participants at risk
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
|
Group 4: TDV SC_2 Doses Day 0
n=17 participants at risk
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Group 5: TDV IM_2 Doses Day 0
n=16 participants at risk
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Neuralgia
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
Other adverse events
| Measure |
Group 1: TDV SC_ 2 Doses Day 0
n=14 participants at risk
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 2: TDV IM_2 Doses Day 0
n=16 participants at risk
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
|
Group 3: TDV IM_2 Doses Days 0 and 90
n=17 participants at risk
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
|
Group 4: TDV SC_2 Doses Day 0
n=17 participants at risk
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
Group 5: TDV IM_2 Doses Day 0
n=16 participants at risk
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
|
|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
General disorders
Chest pain
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
General disorders
Chills
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
General disorders
Injection site scar
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
General disorders
Pain
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Infections and infestations
Eye infection
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Infections and infestations
Tooth infection
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
11.8%
2/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
11.8%
2/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
12.5%
2/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Infections and infestations
Viral infection
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
12.5%
2/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Nervous system disorders
Migraine
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
11.8%
2/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
11.8%
2/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
11.8%
2/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Vascular disorders
Hot flush
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Endocrine disorders
Endocrine disorder
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Eye disorders
Eye pain
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
6.2%
1/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
12.5%
2/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
5.9%
1/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
Gastrointestinal disorders
Toothache
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
|
General disorders
Asthenia
|
7.1%
1/14 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/17 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
0.00%
0/16 • Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.
|
Additional Information
Takeda Study Registration Call Center, Central Contact
Takeda
Phone: +1-877-825-3327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER