Trial Outcomes & Findings for Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali (NCT NCT00308061)
NCT ID: NCT00308061
Last Updated: 2017-07-31
Results Overview
Number of participants with solicited adverse events by immunization and type (local, general and any) during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Days 0, 1, 2, 3, 7, 30, 31, 32, 33, 37, 60, 61, 62, 63, 67
Results posted on
2017-07-31
Participant Flow
40 subjects were randomized at 1:1 ratio to receive either FMP1/AS02A or Imovax Rabies vaccine. All 40 subjects received all 3 immunizations and were followed for 12 months
Participant milestones
| Measure |
FMP1/AS02A Vaccine
500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.
|
Imovax Rabies Vaccine
1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, \<150g of neomycin sulfate, and \>2.5 IU of rabies antigen.
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|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali
Baseline characteristics by cohort
| Measure |
FMP1/AS02A Vaccine
n=20 Participants
500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.
|
Imovax Rabies Vaccine
n=20 Participants
1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, \<150g of neomycin sulfate, and \>2.5 IU of rabies antigen.
|
Total
n=40 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
40.3 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
Mali
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 0, 1, 2, 3, 7, 30, 31, 32, 33, 37, 60, 61, 62, 63, 67Number of participants with solicited adverse events by immunization and type (local, general and any) during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7.
Outcome measures
| Measure |
Imovax Rabies Vaccine
n=20 Participants
1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, \<150g of neomycin sulfate, and \>2.5 IU of rabies antigen.
|
FMP1/AS02A Vaccine
n=20 Participants
500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.
|
|---|---|---|
|
Number of Participants With Solicited Adverse Events by Immunization and Type
Immunization 3: General Symptom
|
5 Participants
|
8 Participants
|
|
Number of Participants With Solicited Adverse Events by Immunization and Type
Immunization 1: Any Symptom
|
8 Participants
|
18 Participants
|
|
Number of Participants With Solicited Adverse Events by Immunization and Type
Immunization 2: Any Symptom
|
12 Participants
|
13 Participants
|
|
Number of Participants With Solicited Adverse Events by Immunization and Type
Immunization 2: Local Symptom
|
7 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events by Immunization and Type
Immunization 1: Local Symptom
|
4 Participants
|
13 Participants
|
|
Number of Participants With Solicited Adverse Events by Immunization and Type
Immunization 1: General Symptom
|
4 Participants
|
14 Participants
|
|
Number of Participants With Solicited Adverse Events by Immunization and Type
Immunization 2: General Symptom
|
8 Participants
|
12 Participants
|
|
Number of Participants With Solicited Adverse Events by Immunization and Type
Immunization 3: Any Symptom
|
11 Participants
|
11 Participants
|
|
Number of Participants With Solicited Adverse Events by Immunization and Type
Immunization 3: Local Symptom
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Days 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364Population: Immune response was measured by anti-FMP1 endpoint titers. Data were obtained on day 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364. Samples collected on vaccination days (days 0, 30, and 60) were collected immediately prior to vaccination.
Immune response was measured by anti-FMP1 endpoint titers. Data were obtained on day 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364. Samples collected on vaccination days (days 0, 30, and 60) were collected immediately prior to vaccination.
Outcome measures
| Measure |
Imovax Rabies Vaccine
n=40 Participants
1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, \<150g of neomycin sulfate, and \>2.5 IU of rabies antigen.
|
FMP1/AS02A Vaccine
500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.
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|---|---|---|
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Geometric Mean Titers for Anti-FMP1 Antibody
Imovax: Pre-Imm 3
|
6915 geometric mean titers
Interval 3148.0 to 15190.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
Imovax: Imm 3+30 days
|
6892 geometric mean titers
Interval 3645.0 to 13029.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
Imovax: Pre-Imm 1
|
3282 geometric mean titers
Interval 1423.0 to 7568.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
Imovax: Imm 1+14 days
|
3089 geometric mean titers
Interval 1332.0 to 7161.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
Imovax: Pre-Imm 2
|
3485 geometric mean titers
Interval 1391.0 to 8728.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
Imovax: Imm 2+14 days
|
4036 geometric mean titers
Interval 1796.0 to 9071.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
Imovax: Imm 3+14 days
|
7051 geometric mean titers
Interval 3477.0 to 14300.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
Imovax: Day 180
|
9089 geometric mean titers
Interval 3817.0 to 21645.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
Imovax: Day 272
|
6367 geometric mean titers
Interval 2743.0 to 14779.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
Imovax: Day 364
|
5015 geometric mean titers
Interval 2194.0 to 11462.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
FMP1/AS02A: Pre-Imm 1
|
5858 geometric mean titers
Interval 2650.0 to 12950.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
FMP1/AS02A: Imm 1+14 days
|
7627 geometric mean titers
Interval 3561.0 to 16336.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
FMP1/AS02A: Pre-Imm 2
|
8007 geometric mean titers
Interval 3809.0 to 16831.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
FMP1/AS02A: Imm 2+14 days
|
20044 geometric mean titers
Interval 12994.0 to 30919.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
FMP1/AS02A: Pre-Imm 3
|
26321 geometric mean titers
Interval 19611.0 to 35326.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
FMP1/AS02A: Imm 3+14 days
|
35194 geometric mean titers
Interval 26245.0 to 47194.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
FMP1/AS02A: Day 272
|
19518 geometric mean titers
Interval 11181.0 to 34072.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
FMP1/AS02A: Day 364
|
14693 geometric mean titers
Interval 8216.0 to 26276.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
FMP1/AS02A: Imm 3+30 days
|
37923 geometric mean titers
Interval 26788.0 to 53686.0
|
—
|
|
Geometric Mean Titers for Anti-FMP1 Antibody
FMP1/AS02A: Day 180
|
29150 geometric mean titers
Interval 18301.0 to 46432.0
|
—
|
Adverse Events
Imovax Rabies Vaccine
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
FMP1/AS02A Vaccine
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imovax Rabies Vaccine
n=20 participants at risk
1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, \<150g of neomycin sulfate, and \>2.5 IU of rabies antigen.
|
FMP1/AS02A Vaccine
n=20 participants at risk
500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.
|
|---|---|---|
|
Reproductive system and breast disorders
Tubal ectopic pregnancy (right side)
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitus
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
Other adverse events
| Measure |
Imovax Rabies Vaccine
n=20 participants at risk
1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, \<150g of neomycin sulfate, and \>2.5 IU of rabies antigen.
|
FMP1/AS02A Vaccine
n=20 participants at risk
500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle
FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Musculoskeletal and connective tissue disorders
Arm motion limitation
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
30.0%
6/20 • Number of events 6 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Anus disorder
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
15.0%
3/20 • Number of events 3 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
General disorders
Asthenia
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
General disorders
Ataxia
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
3/20 • Number of events 3 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Bloody diarrhea
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Cardiac disorders
Bradycardia
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnea
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Musculoskeletal and connective tissue disorders
Chills
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Infections and infestations
Conjunctivitis
|
40.0%
8/20 • Number of events 8 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Diarrhea
|
15.0%
3/20 • Number of events 3 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
25.0%
5/20 • Number of events 5 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
5/20 • Number of events 5 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Renal and urinary disorders
Dysuria
|
15.0%
3/20 • Number of events 3 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
General disorders
Fatigue
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
15.0%
3/20 • Number of events 3 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
General disorders
Fever
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
General disorders
Flu like symptoms
|
25.0%
5/20 • Number of events 5 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
15.0%
3/20 • Number of events 3 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Nervous system disorders
Headache
|
40.0%
8/20 • Number of events 8 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
100.0%
20/20 • Number of events 20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Cardiac disorders
Heart murmur
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Vascular disorders
Hemorrhoids
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Vascular disorders
Hot flushes
|
50.0%
10/20 • Number of events 10 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
100.0%
20/20 • Number of events 20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Infections and infestations
Infection
|
25.0%
5/20 • Number of events 5 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
50.0%
10/20 • Number of events 10 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Injury, poisoning and procedural complications
Inflammation at injection site
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
40.0%
8/20 • Number of events 8 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
15.0%
3/20 • Number of events 3 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Injury, poisoning and procedural complications
Injury
|
20.0%
4/20 • Number of events 4 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
35.0%
7/20 • Number of events 7 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Eye disorders
Lacrimation abnormal
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Reproductive system and breast disorders
Leukorrhea
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
General disorders
Malaise
|
35.0%
7/20 • Number of events 7 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
40.0%
8/20 • Number of events 8 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Blood and lymphatic system disorders
Malaria
|
25.0%
5/20 • Number of events 5 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
25.0%
5/20 • Number of events 5 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • Number of events 3 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
25.0%
5/20 • Number of events 5 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Nervous system disorders
Neuralgia
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Ear and labyrinth disorders
Otitis
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Infections and infestations
Otitis media
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Injury, poisoning and procedural complications
Pain at injection site
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
20.0%
4/20 • Number of events 4 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
15.0%
3/20 • Number of events 3 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Reproductive system and breast disorders
Pregnancy
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Eye disorders
Pruritus ocular
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Eye disorders
Pterygium
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.0%
3/20 • Number of events 3 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Infections and infestations
Rhinitis
|
40.0%
8/20 • Number of events 8 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
50.0%
10/20 • Number of events 10 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Musculoskeletal and connective tissue disorders
Rigors
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Saliva increased
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Injury, poisoning and procedural complications
Site mass at injection site
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
General disorders
Sweating increased
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
General disorders
Swelling
|
75.0%
15/20 • Number of events 15 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
100.0%
20/20 • Number of events 20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Nervous system disorders
Taste perversion
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Metabolism and nutrition disorders
Thirst
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Tooth ache
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Tooth caries aggrevated
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Tooth disorder
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Renal and urinary disorders
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
5.0%
1/20 • Number of events 1 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Eye disorders
Vision accomodation abnormal
|
10.0%
2/20 • Number of events 2 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
|
15.0%
3/20 • Number of events 3 • Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3). Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities
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Additional Information
Mahamadou A. Thera, MD MPH
University of Bamako Faculty of Medicine, Mali
Phone: 223-222-1809
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place