Trial Outcomes & Findings for Phase I Pediatric FMP2.1/AS02A Trial in Mali (NCT NCT00358332)
NCT ID: NCT00358332
Last Updated: 2011-10-24
Results Overview
The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
100 participants
Primary outcome timeframe
7 Days following any vaccination
Results posted on
2011-10-24
Participant Flow
Parents in Bandiagara Mali were made aware of the study by a radio announcement and voluntarily brought their children to the Bandiagara Malaria Project (BMP) clinic on the campus of the Bandiagara District Hospital in Bandiagara, Mali. The first subject was enrolled on November 3, 2006 and the final subject was enrolled on December 12, 2006.
Participant milestones
| Measure |
FMP2.1/AS02A 10 Mcg
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
30
|
30
|
25
|
|
Overall Study
COMPLETED
|
15
|
27
|
29
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Pediatric FMP2.1/AS02A Trial in Mali
Baseline characteristics by cohort
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
3.5 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
3.5 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
3.6 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
3.2 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
3.4 years
STANDARD_DEVIATION 1.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Region of Enrollment
Mali
|
15 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
25 participants
n=4 Participants
|
100 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 7 Days following any vaccinationPopulation: This outcome includes all enrolled subjects.
The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions.
Outcome measures
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.
Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.
Irritability/Fussiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.
Loss of Appetite
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.
Vomiting
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.
Feverishness
|
3 Participants
|
17 Participants
|
16 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day of vaccination and 30 subsequent days.Population: This outcome includes all enrolled subjects.
The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions.
Outcome measures
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60.
|
4 Participants
|
7 Participants
|
10 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1 year after the last vaccination.Population: This outcome includes all enrolled subjects.
Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.
Outcome measures
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Number of Subjects Spontaneously Reporting Any Serious Adverse Event.
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 7 Days following any vaccinationPopulation: This outcome includes all enrolled subjects.
The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions.
Outcome measures
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.
Site Pain
|
11 Participants
|
27 Participants
|
27 Participants
|
6 Participants
|
|
Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.
Swelling
|
13 Participants
|
28 Participants
|
30 Participants
|
11 Participants
|
|
Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.
Erythema
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0Population: Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Outcome measures
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0
|
2.73 log anti-FMP2.1 titer
Interval 1.99 to 3.47
|
2.70 log anti-FMP2.1 titer
Interval 2.22 to 3.17
|
3.04 log anti-FMP2.1 titer
Interval 2.65 to 3.42
|
2.66 log anti-FMP2.1 titer
Interval 2.18 to 3.14
|
SECONDARY outcome
Timeframe: Day 30 +/- 7 daysPopulation: Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Outcome measures
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=29 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=24 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30
|
4.09 log anti-FMP2.1 titer
Interval 3.78 to 4.41
|
4.20 log anti-FMP2.1 titer
Interval 4.04 to 4.36
|
4.31 log anti-FMP2.1 titer
Interval 4.18 to 4.44
|
2.57 log anti-FMP2.1 titer
Interval 2.05 to 3.09
|
SECONDARY outcome
Timeframe: Day 60 +/- 7 daysPopulation: Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Outcome measures
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=29 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=24 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60
|
4.78 log anti-FMP2.1 titer
Interval 4.61 to 4.96
|
4.98 log anti-FMP2.1 titer
Interval 4.84 to 5.11
|
4.97 log anti-FMP2.1 titer
Interval 4.89 to 5.05
|
2.53 log anti-FMP2.1 titer
Interval 2.03 to 3.03
|
SECONDARY outcome
Timeframe: Day 90 +/- 10 daysPopulation: Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Outcome measures
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=30 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=29 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90
|
4.93 log anti-FMP2.1 titer
Interval 4.75 to 5.11
|
5.22 log anti-FMP2.1 titer
Interval 5.06 to 5.37
|
5.05 log anti-FMP2.1 titer
Interval 4.91 to 5.19
|
2.41 log anti-FMP2.1 titer
Interval 1.98 to 2.84
|
SECONDARY outcome
Timeframe: Day 180 +/- 14 daysPopulation: Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Outcome measures
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=29 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=29 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180
|
4.53 log anti-FMP2.1 titer
Interval 4.33 to 4.73
|
4.73 log anti-FMP2.1 titer
Interval 4.6 to 4.86
|
4.57 log anti-FMP2.1 titer
Interval 4.42 to 4.72
|
2.15 log anti-FMP2.1 titer
Interval 1.75 to 2.54
|
SECONDARY outcome
Timeframe: Day 272 +/- 14 daysPopulation: Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Outcome measures
| Measure |
FMP2.1/AS02A 10 Mcg
n=14 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=29 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=29 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272.
|
4.25 log anti-FMP2.1 titer
Interval 4.05 to 4.45
|
4.43 log anti-FMP2.1 titer
Interval 4.29 to 4.58
|
4.51 log anti-FMP2.1 titer
Interval 4.33 to 4.7
|
2.13 log anti-FMP2.1 titer
Interval 1.78 to 2.48
|
SECONDARY outcome
Timeframe: Day 364 +/- 14 daysPopulation: Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point is available.
This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Outcome measures
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 Participants
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=27 Participants
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=29 Participants
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 Participants
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364
|
4.36 log anti-FMP2.1 titer
Interval 4.16 to 4.56
|
4.68 log anti-FMP2.1 titer
Interval 4.46 to 4.91
|
4.42 log anti-FMP2.1 titer
Interval 4.27 to 4.57
|
2.56 log anti-FMP2.1 titer
Interval 2.2 to 2.92
|
Adverse Events
FMP2.1/AS02A 10 Mcg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
FMP2.1/AS02A 25 Mcg
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
FMP2.1/AS02A 50 Mcg
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
RabAvert(R)
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 participants at risk
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=30 participants at risk
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=30 participants at risk
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 participants at risk
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
8.0%
2/25 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Investigations
White blood cell count increased
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
Other adverse events
| Measure |
FMP2.1/AS02A 10 Mcg
n=15 participants at risk
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 25 Mcg
n=30 participants at risk
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
FMP2.1/AS02A 50 Mcg
n=30 participants at risk
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
RabAvert(R)
n=25 participants at risk
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Blood and lymphatic system disorders
Splenomegaly
|
13.3%
2/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Ear and labyrinth disorders
Cerumen impaction
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Eye disorders
Conjunctivitis
|
13.3%
2/15 • Number of events 8 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
10.0%
3/30 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
23.3%
7/30 • Number of events 8 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
20.0%
5/25 • Number of events 5 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Eye disorders
Conjunctivitis allergic
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Eye disorders
Eye pruritus
|
13.3%
2/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
40.0%
12/30 • Number of events 13 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
13.3%
4/30 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Dental caries
|
13.3%
2/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
4/15 • Number of events 9 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
26.7%
8/30 • Number of events 18 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
33.3%
10/30 • Number of events 14 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
36.0%
9/25 • Number of events 17 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Gingivitis
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Oral disorder
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Rectal prolapse
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
6.7%
1/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Tooth loss
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Umbilical hernia
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
16.7%
5/30 • Number of events 5 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
8.0%
2/25 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
General disorders
Asthenia
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Pyrexia
|
26.7%
4/15 • Number of events 6 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
30.0%
9/30 • Number of events 13 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
13.3%
4/30 • Number of events 5 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
12.0%
3/25 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Hepatobiliary disorders
Jaundice
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Amoebic dysentery
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
8.0%
2/25 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Bronchitis
|
40.0%
6/15 • Number of events 14 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
36.7%
11/30 • Number of events 19 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
40.0%
12/30 • Number of events 20 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
44.0%
11/25 • Number of events 18 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Candidiasis
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Ear infection
|
33.3%
5/15 • Number of events 6 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
40.0%
12/30 • Number of events 15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
20.0%
6/30 • Number of events 7 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
40.0%
10/25 • Number of events 11 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Fungal skin infection
|
33.3%
5/15 • Number of events 5 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
16.7%
5/30 • Number of events 7 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
30.0%
9/30 • Number of events 9 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
16.0%
4/25 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Furuncle
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
10.0%
3/30 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
8.0%
2/25 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
10.0%
3/30 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
12.0%
3/25 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Giardiasis
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Hepatitis A
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Herpetic stomatitis
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Hymenolepiasis
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Infection parasitic
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Malaria
|
66.7%
10/15 • Number of events 20 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
53.3%
16/30 • Number of events 25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
70.0%
21/30 • Number of events 28 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
60.0%
15/25 • Number of events 25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Mumps
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
13.3%
4/30 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Nasopharyngitis
|
66.7%
10/15 • Number of events 14 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
43.3%
13/30 • Number of events 22 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
50.0%
15/30 • Number of events 19 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
60.0%
15/25 • Number of events 28 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Oral herpes
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Otitis media
|
13.3%
2/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
10.0%
3/30 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
20.0%
5/25 • Number of events 7 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Pharyngitis
|
33.3%
5/15 • Number of events 5 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
13.3%
4/30 • Number of events 6 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
16.7%
5/30 • Number of events 5 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
16.0%
4/25 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
13.3%
4/30 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
12.0%
3/25 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Pyoderma
|
33.3%
5/15 • Number of events 8 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
26.7%
8/30 • Number of events 8 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
26.7%
8/30 • Number of events 8 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
40.0%
10/25 • Number of events 10 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Rhinitis
|
86.7%
13/15 • Number of events 27 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
56.7%
17/30 • Number of events 30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
73.3%
22/30 • Number of events 42 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
80.0%
20/25 • Number of events 39 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Skin infection
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Streptococcal infection
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Tonsillitis
|
40.0%
6/15 • Number of events 7 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
13.3%
4/30 • Number of events 5 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
23.3%
7/30 • Number of events 7 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
24.0%
6/25 • Number of events 7 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Tooth abscess
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Trichomoniasis intestinal
|
13.3%
2/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
10.0%
3/30 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
10.0%
3/30 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
10.0%
3/30 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Vulvovaginitis
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Infections and infestations
Wound infection
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Injury, poisoning and procedural complications
Injury
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Injury, poisoning and procedural complications
Joint injury
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Injury, poisoning and procedural complications
Thermal burn
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Injury, poisoning and procedural complications
Wound
|
20.0%
3/15 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
20.0%
6/30 • Number of events 6 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
16.7%
5/30 • Number of events 5 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
8.0%
2/25 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Investigations
Cardiac murmur
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
8.0%
2/25 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Investigations
White blood cell count increased
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
10.0%
3/30 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
8.0%
2/25 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Metabolism and nutrition disorders
Pica
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Nervous system disorders
Convulsion
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
20.0%
6/30 • Number of events 8 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Nervous system disorders
Somnolence
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
73.3%
11/15 • Number of events 15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
80.0%
24/30 • Number of events 39 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
56.7%
17/30 • Number of events 26 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
72.0%
18/25 • Number of events 34 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
53.3%
8/15 • Number of events 8 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
36.7%
11/30 • Number of events 17 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
36.7%
11/30 • Number of events 14 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
36.0%
9/25 • Number of events 13 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
13.3%
2/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
10.0%
3/30 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
13.3%
2/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
10.0%
3/30 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
6.7%
2/30 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Vomiting - post dose 1
|
6.7%
1/15 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
General disorders
Injection site pain - post dose 1
|
53.3%
8/15 • Number of events 8 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
63.3%
19/30 • Number of events 19 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
53.3%
16/30 • Number of events 16 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
8.0%
2/25 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
General disorders
Injection site swelling - post dose 1
|
73.3%
11/15 • Number of events 11 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
40.0%
12/30 • Number of events 12 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
93.3%
28/30 • Number of events 28 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
24.0%
6/25 • Number of events 6 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
General disorders
Pyrexia - post dose 1
|
0.00%
0/15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
30.0%
9/30 • Number of events 9 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
26.7%
8/30 • Number of events 8 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Metabolism and nutrition disorders
Anorexia - post dose 1
|
13.3%
2/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
3.3%
1/30 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
General disorders
Injection site pain - post dose 2
|
46.7%
7/15 • Number of events 7 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
50.0%
15/30 • Number of events 15 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
67.9%
19/28 • Number of events 19 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
16.0%
4/25 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
General disorders
Injection site swelling - post dose 2
|
46.7%
7/15 • Number of events 7 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
73.3%
22/30 • Number of events 22 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
78.6%
22/28 • Number of events 22 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
16.0%
4/25 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
General disorders
Pyrexia - post dose 2
|
13.3%
2/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
26.7%
8/30 • Number of events 8 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
21.4%
6/28 • Number of events 6 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
8.0%
2/25 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Metabolism and nutrition disorders
Anorexia - post dose 2
|
13.3%
2/15 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/30 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/28 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/25 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
Gastrointestinal disorders
Vomiting - post dose 3
|
7.1%
1/14 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/27 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/27 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
0.00%
0/23 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
General disorders
Injection site pain - post dose 3
|
21.4%
3/14 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
44.4%
12/27 • Number of events 12 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
59.3%
16/27 • Number of events 16 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
4.3%
1/23 • Number of events 1 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
General disorders
Injection site swelling - - post dose 3
|
71.4%
10/14 • Number of events 10 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
59.3%
16/27 • Number of events 16 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
85.2%
23/27 • Number of events 23 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
13.0%
3/23 • Number of events 3 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
|
General disorders
Pyrexia - post dose 3
|
14.3%
2/14 • Number of events 2 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
18.5%
5/27 • Number of events 5 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
25.9%
7/27 • Number of events 7 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
17.4%
4/23 • Number of events 4 • Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
|
Additional Information
Christopher V. Plowe
University of Maryland School of Medicine
Phone: 410-706-3082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60