Trial Outcomes & Findings for ACAM 3000 MVA at Harvard Medical School (NCT NCT00133575)
NCT ID: NCT00133575
Last Updated: 2015-01-05
Results Overview
Number of participants reporting moderate or greater local reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
72 participants
Primary outcome timeframe
15 days after vaccination
Results posted on
2015-01-05
Participant Flow
Normal healthy vaccinia-naïve young adults who reside in the greater Boston metropolitan area were recruited for this study between September 29, 2005 and April 23, 2007.
Participant milestones
| Measure |
10^6 TCID50 MVA ID
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
10
|
12
|
|
Overall Study
COMPLETED
|
10
|
10
|
8
|
9
|
6
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
4
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ACAM 3000 MVA at Harvard Medical School
Baseline characteristics by cohort
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=12 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
72 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
24 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
24.7 years
STANDARD_DEVIATION 4.1 • n=4 Participants
|
26.5 years
STANDARD_DEVIATION 2.2 • n=21 Participants
|
24.2 years
STANDARD_DEVIATION 3.6 • n=8 Participants
|
25.6 years
STANDARD_DEVIATION 3.9 • n=8 Participants
|
25.2 years
STANDARD_DEVIATION 3.7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
43 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
29 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
10 participants
n=21 Participants
|
10 participants
n=8 Participants
|
12 participants
n=8 Participants
|
72 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 15 days after vaccinationNumber of participants reporting moderate or greater local reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=12 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Moderate or Greater Solicited Local Reactions
Limitation of motion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Local Reactions
Pain at injection site
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Local Reactions
Tenderness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Local Reactions
Erythema
|
3 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
9 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Local Reactions
Induration
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Local Reactions
Itchiness at vaccination site
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Local Reactions
Rash
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 15 days after vaccinationNumber of participants reporting moderate or greater systemic reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=12 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions
Headache
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions
Underarm swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions
Nausea
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions
Oral temperature elevated
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions
Change in appetite
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions
Underarm pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions
Chills
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions
Feeling tired
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions
Joint pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions
Muscle aches
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 days after vaccinationNumber of participants with hematologic laboratory abnormalities after vaccination, including hemoglobin, white blood cell count, neutrophil count and platelet count. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=12 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematologic Laboratory Abnormalities After Vaccination
Hemoglobin
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Hematologic Laboratory Abnormalities After Vaccination
White blood cells
|
4 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Hematologic Laboratory Abnormalities After Vaccination
Neutrophil count
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematologic Laboratory Abnormalities After Vaccination
Platelets
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 days after vaccinationNumber of participants with clinical chemistry laboratory abnormalities after vaccination, including total bilirubin and serum creatinine. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=12 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Laboratory Abnormalities After Vaccination
Bilirubin
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Abnormalities After Vaccination
Creatinine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 28 days after vaccinationNumber of participants with enzymatic clinical laboratory abnormalities after vaccination, including AST, ALT and alkaline phosphatase. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=12 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Enzymatic Clinical Laboratory Abnormalities After Vaccination
ALT (SGOT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Enzymatic Clinical Laboratory Abnormalities After Vaccination
Alkaline Phosphatase
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Enzymatic Clinical Laboratory Abnormalities After Vaccination
AST (SGPT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 28 days after vaccinationNumber of participants with urinalysis laboratory abnormalies after vaccination, including proteinuria and hematuria by dipstick. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=12 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Urinalysis Laboratory Abnormalies After Vaccination
Proteinuria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Laboratory Abnormalies After Vaccination
Hematuria
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 360 days after vaccinationNumber of participants with signs of possible myopericarditis, either by clinical or laboratory (EKG, troponin) evaluation, at any time after vaccination for the during of the study
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=12 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Signs of Possible Myopericarditis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately Day 42 after first vaccinationMedian neutralizing antibody titers against ACAM3000 MVA as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=8 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=10 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Peak Neutralizing Antibodies to ACAM3000 MVA
|
27 Titers
Interval 20.0 to 76.0
|
74 Titers
Interval 52.0 to 113.0
|
68 Titers
Interval 51.0 to 126.0
|
202 Titers
Interval 157.0 to 569.0
|
220 Titers
Interval 49.0 to 695.0
|
333 Titers
Interval 177.0 to 584.0
|
20 Titers
Interval 20.0 to 20.0
|
SECONDARY outcome
Timeframe: Approximately Day 42 after first vaccinationMedian neutralizing antibody titers against vaccinia virus as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=8 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=10 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Peak Neutralizing Antibodies to Vaccinia
|
20 Titers
Interval 20.0 to 20.0
|
20 Titers
Interval 20.0 to 39.0
|
24 Titers
Interval 20.0 to 32.0
|
70 Titers
Interval 58.0 to 141.0
|
129 Titers
Interval 41.0 to 274.0
|
179 Titers
Interval 88.0 to 237.0
|
20 Titers
Interval 20.0 to 20.0
|
SECONDARY outcome
Timeframe: Approximately Day 42 after first vaccinationMedian binding antibody titers against ACAM3000 MVA as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=8 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=10 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Peak Binding Antibodies (ELISA) to ACAM3000 MVA
|
90 Titers
Interval 30.0 to 810.0
|
270 Titers
Interval 270.0 to 2430.0
|
270 Titers
Interval 270.0 to 810.0
|
810 Titers
Interval 810.0 to 7290.0
|
2430 Titers
Interval 270.0 to 2430.0
|
2430 Titers
Interval 810.0 to 2430.0
|
30 Titers
Interval 30.0 to 30.0
|
SECONDARY outcome
Timeframe: Approximately Day 42 after first vaccinationMedian binding antibody titers against vaccinia virus as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=8 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=10 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Peak Binding Antibodies (ELISA) to Vaccinia
|
90 Titers
Interval 30.0 to 270.0
|
540 Titers
Interval 30.0 to 2430.0
|
540 Titers
Interval 270.0 to 810.0
|
4860 Titers
Interval 2430.0 to 7290.0
|
540 Titers
Interval 270.0 to 2430.0
|
2430 Titers
Interval 810.0 to 2430.0
|
30 Titers
Interval 30.0 to 30.0
|
SECONDARY outcome
Timeframe: Approximately Day 42 after first vaccinationMedian T-cell gamma interferon responses against the vaccinia virus as the assay antigen, as assessed by ELISPOT from sera collected 2 weeks after receipt of 2 doses. Responses are expressed as the number of spot forming units per 10\^6 peripheral blood mononuclear cells (SFU/10\^6 PBMC).
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=8 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=10 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Peak T-cell Gamma Interferon Responses (ELISPOT)
|
61 SFU/10^6 PBMC
Interval 0.0 to 89.0
|
373 SFU/10^6 PBMC
Interval 175.0 to 637.0
|
114 SFU/10^6 PBMC
Interval 79.0 to 279.0
|
99 SFU/10^6 PBMC
Interval 36.0 to 198.0
|
38 SFU/10^6 PBMC
Interval 14.0 to 137.0
|
185 SFU/10^6 PBMC
Interval 113.0 to 377.0
|
10 SFU/10^6 PBMC
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Until vaccination site lesion has scabbedMedian Dryvax virus titers as assessed from swabs of the vaccination site lesion taken at intervals until the vaccination site is scabbed. The maximum titer recovered during the sampling period for each participant is utilized in determining the median for the group.
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=2 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=5 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=7 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=6 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=9 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=7 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Peak Titer of Viral Shedding Post Dryvax Challenge
|
497,000 Titers
|
52,500 Titers
|
23,000 Titers
|
570 Titers
Interval 0.0 to
|
11,550 Titers
Interval 0.0 to
|
—
|
480,000 Titers
|
SECONDARY outcome
Timeframe: 3 weeks after Dryvax challengeRestricted to participants who received Dryvax 6-15 months after MVA. A "take" is a vesicle surrounded by a red areola which becomes umbilicated and then pustular before scabbing. Category 0=No take; Category 1=Significant modified take skin reaction; Category 2=Modified take skin reaction; Category 3=Primary take skin reaction
Outcome measures
| Measure |
10^6 TCID50 MVA ID
n=2 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=4 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=7 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=6 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=9 Participants
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=7 Participants
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Assessment of Dryvax Take Category
Category 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Assessment of Dryvax Take Category
Category 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Assessment of Dryvax Take Category
Category 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Assessment of Dryvax Take Category
Category 3
|
2 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
9 Participants
|
—
|
7 Participants
|
Adverse Events
10^6 TCID50 MVA ID
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
10^7 TCID50 MVA IM
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
10^7 TCID50 MVA SC
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
10^8 TCID50 MVA SC
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
10^7 TCID50 MVA ID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
10^8 TCID50 MVA IM
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Saline Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10^6 TCID50 MVA ID
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=12 participants at risk
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Amenorrhoea
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
Other adverse events
| Measure |
10^6 TCID50 MVA ID
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^7 TCID50 MVA IM
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
10^7 TCID50 MVA SC
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^8 TCID50 MVA SC
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
|
10^7 TCID50 MVA ID
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
|
10^8 TCID50 MVA IM
n=10 participants at risk
ACAM3000 Modified Vaccinia Ankara dose 10\^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
|
Saline Placebo
n=12 participants at risk
Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
|
|---|---|---|---|---|---|---|---|
|
Investigations
Blood pressure systolic decreased
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Investigations
Heart rate increased
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Injury, poisoning and procedural complications
Back injury
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Investigations
White blood cell count increased
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Investigations
Blood pressure
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Chills - post dose 1
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Metabolism and nutrition disorders
Appetite disorder - post dose 2
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Metabolism and nutrition disorders
Appetite disorder - post Dryvax
|
0.00%
0/2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
28.6%
2/7 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
11.1%
1/9 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
28.6%
2/7 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Chills - post dose 2
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Chills - post Dryvax
|
0.00%
0/2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
1/5 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
14.3%
1/7 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/9 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site erythema - post dose 1
|
70.0%
7/10 • Number of events 7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
60.0%
6/10 • Number of events 6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
90.0%
9/10 • Number of events 9 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
25.0%
3/12 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site erythema - post dose 2
|
80.0%
8/10 • Number of events 8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
25.0%
2/8 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
80.0%
8/10 • Number of events 8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
100.0%
10/10 • Number of events 10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site erythema - post Dryvax
|
100.0%
2/2 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
100.0%
5/5 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
100.0%
7/7 • Number of events 7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
100.0%
6/6 • Number of events 6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
77.8%
7/9 • Number of events 7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
100.0%
7/7 • Number of events 7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Fatigue - post dose 1
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
5/10 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
5/10 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Fatigue - post dose 2
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
37.5%
3/8 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
5/10 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
9.1%
1/11 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Fatigue - post Dryvax
|
0.00%
0/2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
60.0%
3/5 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
57.1%
4/7 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
16.7%
1/6 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
11.1%
1/9 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Nervous system disorders
Headache - post dose 1
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
5/10 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Nervous system disorders
Headache - post dose 2
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
12.5%
1/8 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Nervous system disorders
Headache - post Dryvax
|
0.00%
0/2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
60.0%
3/5 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
14.3%
1/7 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
11.1%
1/9 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
14.3%
1/7 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site induration - post dose 1
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
80.0%
8/10 • Number of events 8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
90.0%
9/10 • Number of events 9 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
16.7%
2/12 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site induration - post dose 2
|
50.0%
5/10 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
25.0%
2/8 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
80.0%
8/10 • Number of events 8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
100.0%
10/10 • Number of events 10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site induration - post Dryvax
|
100.0%
2/2 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
100.0%
5/5 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
100.0%
7/7 • Number of events 7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
100.0%
6/6 • Number of events 6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
77.8%
7/9 • Number of events 7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
100.0%
7/7 • Number of events 7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site pruritus - post dose 1
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
60.0%
6/10 • Number of events 6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site pruritus - post dose 2
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
25.0%
2/8 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
60.0%
6/10 • Number of events 6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
60.0%
6/10 • Number of events 6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site pruritus - post Dryvax
|
100.0%
2/2 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
80.0%
4/5 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
85.7%
6/7 • Number of events 6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
3/6 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
55.6%
5/9 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
85.7%
6/7 • Number of events 6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - post dose 1
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - post dose 2
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Nervous system disorders
Sinus headache
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Surgical and medical procedures
Endodontic procedure
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Metabolism and nutrition disorders
Appetite disorder - post dose 1
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - post Dryvax
|
50.0%
1/2 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
1/5 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
14.3%
1/7 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/9 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
14.3%
1/7 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased - post dose 1
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased - post dose 2
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased - post Dryvax
|
0.00%
0/2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
1/5 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
14.3%
1/7 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/9 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia - post dose 1
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
5/10 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
5/10 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia - post dose 2
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
5/10 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
12.5%
1/8 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia - post Dryvax
|
50.0%
1/2 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
40.0%
2/5 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
42.9%
3/7 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/9 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
28.6%
2/7 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Gastrointestinal disorders
Nausea - post dose 1
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Gastrointestinal disorders
Nausea - post dose 2
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Gastrointestinal disorders
Nausea - post Dryvax
|
0.00%
0/2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
28.6%
2/7 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
11.1%
1/9 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
14.3%
1/7 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Pyrexia - post dose 1
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Pyrexia - post dose 2
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Pyrexia - post Dryvax
|
0.00%
0/2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
14.3%
1/7 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/9 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site pain - post dose 1
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
5/10 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
60.0%
6/10 • Number of events 6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
80.0%
8/10 • Number of events 8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
70.0%
7/10 • Number of events 7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
90.0%
9/10 • Number of events 9 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site pain - post dose 2
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
5/10 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
75.0%
6/8 • Number of events 6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
90.0%
9/10 • Number of events 9 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
70.0%
7/10 • Number of events 7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
60.0%
6/10 • Number of events 6 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
9.1%
1/11 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site pain - post Dryvax
|
100.0%
2/2 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
60.0%
3/5 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
57.1%
4/7 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
16.7%
1/6 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
22.2%
2/9 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
57.1%
4/7 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Skin and subcutaneous tissue disorders
Rash - post dose 1
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Skin and subcutaneous tissue disorders
Rash - post dose 2
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Tenderness - post dose 1
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
80.0%
8/10 • Number of events 8 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
5/10 • Number of events 5 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Tenderness - post dose 2
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
37.5%
3/8 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
9.1%
1/11 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Axillary pain - post dose 1
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Axillary pain - post dose 2
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
12.5%
1/8 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/11 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Axillary pain - post Dryvax
|
50.0%
1/2 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
1/5 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
42.9%
3/7 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
16.7%
1/6 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
11.1%
1/9 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
57.1%
4/7 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Swelling - post dose 1
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Swelling - post Dryvax
|
0.00%
0/2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
1/5 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
14.3%
1/7 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
16.7%
1/6 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
11.1%
1/9 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
—
0/0 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
57.1%
4/7 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Cardiac disorders
Bradycardia
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Eye disorders
Visual disturbance
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
8.3%
1/12 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Chest discomfort
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Chest pain
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Injection site discolouration
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Pain
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
General disorders
Upper extremity mass
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Body tinea
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Diarrhoea infectious
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Gastroenteritis
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Localized infection
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Nasopharyngitis
|
60.0%
6/10 • Number of events 9 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
30.0%
3/10 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
50.0%
5/10 • Number of events 9 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
40.0%
4/10 • Number of events 7 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
33.3%
4/12 • Number of events 4 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Ear infection
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
2/10 • Number of events 2 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
16.7%
2/12 • Number of events 3 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
|
Infections and infestations
Vaginal candidiasis
|
10.0%
1/10 • Number of events 1 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/10 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
0.00%
0/12 • Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60